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THE WOODLANDS, TX / ACCESSWIRE / November 2, 2016 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing personalized immunotherapies for autoimmune disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that it was implementing an approximately 40% reduction to the Company's current workforce in order to reduce operating expenses and conserve cash resources. The move comes as the Company recently announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna® (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with this current workforce reduction. Moreover, the Company expects that additional restructuring will occur by year-end. Additionally, the Company has accepted the resignations of Ms. Donna Rill, Opexa's Chief Development Officer, and Mr. Scott Seaman, a member of the Company's Board of Directors. Ms. Rill, who is leaving to pursue other career opportunities, will depart as of November 4, 2016. "This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna, announced last week," said Neil K. Warma, President and Chief Executive Officer of Opexa. "I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment to Tcelna and Opexa. The Opexa team has endeavored to increase the understanding of secondary progressive multiple sclerosis, and we hope our work will contribute to the development of a safe and effective therapy for this devastating disease. I would also like to thank Scott Seaman for his long-time service as a Director of Opexa and note our special heartfelt appreciation of Donna Rill who has dedicated over 15 years to Opexa." Opexa Therapeutics is a biopharmaceutical company developing personalized immunotherapies based on ImmPath®, its proprietary T-cell technology, with the potential to treat autoimmune diseases. Opexa's staff of cell therapy experts operates in a stand-alone facility located on one acre in the Woodlands, Texas. The facility is comprised of over 10,000 sq. ft. of state of the art space for cGMP manufacturing suites, a quality control laboratory, a research and development laboratory, quality assurance, specialized flow cytometry, a microscopy lab and clinical and regulatory affairs, as well as warehouse space for materials management. Opexa's patent estate is currently comprised of over 160 issued patents (domestic and international). For more information, please visit Opexa Therapeutics' website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO or LinkedIn. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995. Statements contained in this report, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the reduction-in-workforce and the anticipated future reduction in operating expenses and cash conservation benefits associated therewith, and the future charges expected to be incurred, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with possible changes in the magnitude of the planned workforce reduction, including as a result of changes that may occur in the Company's operations or operating plan, or other reasons or events, possible changes in the amount of charges and cash payments associated with the workforce reduction, including the possibility that the Company may incur unanticipated charges or make cash payments that are not currently contemplated, and the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of the workforce reduction. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date. THE WOODLANDS, TX / ACCESSWIRE / November 2, 2016 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing personalized immunotherapies for autoimmune disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that it was implementing an approximately 40% reduction to the Company's current workforce in order to reduce operating expenses and conserve cash resources. The move comes as the Company recently announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna® (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with this current workforce reduction. Moreover, the Company expects that additional restructuring will occur by year-end. Additionally, the Company has accepted the resignations of Ms. Donna Rill, Opexa's Chief Development Officer, and Mr. Scott Seaman, a member of the Company's Board of Directors. Ms. Rill, who is leaving to pursue other career opportunities, will depart as of November 4, 2016. "This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna, announced last week," said Neil K. Warma, President and Chief Executive Officer of Opexa. "I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment to Tcelna and Opexa. The Opexa team has endeavored to increase the understanding of secondary progressive multiple sclerosis, and we hope our work will contribute to the development of a safe and effective therapy for this devastating disease. I would also like to thank Scott Seaman for his long-time service as a Director of Opexa and note our special heartfelt appreciation of Donna Rill who has dedicated over 15 years to Opexa." Opexa Therapeutics is a biopharmaceutical company developing personalized immunotherapies based on ImmPath®, its proprietary T-cell technology, with the potential to treat autoimmune diseases. Opexa's staff of cell therapy experts operates in a stand-alone facility located on one acre in the Woodlands, Texas. The facility is comprised of over 10,000 sq. ft. of state of the art space for cGMP manufacturing suites, a quality control laboratory, a research and development laboratory, quality assurance, specialized flow cytometry, a microscopy lab and clinical and regulatory affairs, as well as warehouse space for materials management. Opexa's patent estate is currently comprised of over 160 issued patents (domestic and international). For more information, please visit Opexa Therapeutics' website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO or LinkedIn. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995. Statements contained in this report, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the reduction-in-workforce and the anticipated future reduction in operating expenses and cash conservation benefits associated therewith, and the future charges expected to be incurred, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with possible changes in the magnitude of the planned workforce reduction, including as a result of changes that may occur in the Company's operations or operating plan, or other reasons or events, possible changes in the amount of charges and cash payments associated with the workforce reduction, including the possibility that the Company may incur unanticipated charges or make cash payments that are not currently contemplated, and the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of the workforce reduction. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.


THE WOODLANDS, TX / ACCESSWIRE / November 14, 2016 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today reported financial results for the quarter ended September 30, 2016, and provided an update on the Company's clinical development and corporate activities. "Over the past several years, Opexa has dedicated itself to developing therapies to treat patients with high unmet medical needs, such as those with secondary progressive multiple sclerosis," stated Neil K. Warma, President and Chief Executive Officer of Opexa. "We are extremely disappointed that the Abili-T trial did not meet the predefined endpoints, and we are evaluating strategic alternatives for the Company in order to determine the best path forward." On October 28, 2016, Opexa announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna did show a favorable safety and tolerability profile. Further details surrounding the Abili-T trial results can be found in Opexa's 3rd Quarter Form 10-Q, filed this morning with the Securities and Exchange Commission. Opexa is currently analyzing the complete data set from the Abili-T trial. However, based on the top-line results, it is unlikely that the Company will continue with further development of Tcelna. The Company is conducting a review of its other research and development programs, including the preclinical program for OPX-212 in neuromyelitis optica (NMO), to assess the viability of continuing to pursue one or more of these programs. On November 2, 2016, Opexa announced a reduction in workforce of 40% of the Company's then 20 full-time employees while the Company evaluates its programs and various strategic alternatives in light of the disappointing Abili-T study data. The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with workforce reduction. The Company expects that additional restructuring will occur by year-end. On November 2, 2016, Opexa announced that the Company had accepted the resignations of Ms. Donna Rill, Opexa's Chief Development Officer, and Mr. Scott Seaman, a member of Opexa's Board of Directors. Financial Results for the Quarter Ended September 30, 2016 Cash position: Cash and cash equivalents were $5,814,300 as of September 30, 2016, compared to $12,583,764 as of December 31, 2015. As of September 30, 2016, the Company had accounts payable and accrued expenses of $2,121,043. R & D Expense: Research and development expenses were $2,165,728 for the three months ended September 30, 2016, compared with $2,420,220 for the three months ended September 30, 2015. The decrease in expenses is primarily due to cost reductions in connection with the winding down of the clinical trial of Tcelna in SPMS, including site expenses as well as additional expense reduction due to a pause in NMO study development cost. Additionally, there was a decrease in legal patent protection expenses, and the March 2016 workforce reduction further reduced third quarter expenses. These reductions were almost completely offset by the increase in monthly expenses to Pharmaceutical Research Associates, Inc. (PRA), as well as an execution payment and additional milestone payments relating to an amendment entered into for a change order relating to the clinical trials management services agreement for the Abili-T study. G & A Expense: General and administrative expenses were $512,727 for the three months ended September 30, 2016, compared with $1,023,848 for the three months ended September 30, 2015. Net loss: Net loss reported for the three months ended September 30, 2016 was approximately $2.0 million, or $0.28 loss per share (basic and diluted), compared with a net loss of approximately $2.8 million or $0.42 loss per share (basic and diluted) for the three months ended September 30, 2015. Based on the current activities of the Company and projected burn, Opexa believes it has sufficient liquidity to support current activities in winding down the Abili-T trial and for general operations to sustain the Company and support such activities into the first quarter of 2017. For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC. Opexa Therapeutics is a biopharmaceutical company developing personalized immunotherapies based on ImmPath®, its proprietary T-cell technology, with the potential to treat autoimmune diseases. Opexa's staff of cell therapy experts operates in a stand-alone facility located on one acre in the Woodlands, Texas. The facility is comprised of over 10,000 sq. ft. of state of the art space for cGMP manufacturing suites, a quality control laboratory, a research and development laboratory, quality assurance, specialized flow cytometry, a microscopy lab and clinical and regulatory affairs, as well as warehouse space for materials management. Opexa's patent estate is currently comprised of over 160 issued patents (domestic and international). For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO or LinkedIn. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 Statements contained in this report, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the continued development of Tcelna or NMO or any other drug candidate and the Company's evaluation of its research and development programs, the Company's evaluation of various strategic alternatives, the anticipation of additional workforce restructuring, the anticipated current and future reduction in operating expenses and cash conservation benefits associated therewith, and the future charges expected to be incurred, and the sufficiency of the Company's resources, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with the Company's ability to raise additional capital to continue any of its development programs and support its operations, whether the Company continues development of Tcelna, OPX-212 or any of its other research and development programs, possible changes in the magnitude or timing of the planned workforce reduction, including as a result of changes that may occur in the Company's operations or operating plan, or other reasons or events, possible changes in the amount of charges and cash payments associated with the workforce reduction, including the possibility that the Company may incur unanticipated charges or make cash payments that are not currently contemplated, the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of the workforce reduction or any other cost-cutting measures that are implemented, the ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date. THE WOODLANDS, TX / ACCESSWIRE / November 14, 2016 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today reported financial results for the quarter ended September 30, 2016, and provided an update on the Company's clinical development and corporate activities. "Over the past several years, Opexa has dedicated itself to developing therapies to treat patients with high unmet medical needs, such as those with secondary progressive multiple sclerosis," stated Neil K. Warma, President and Chief Executive Officer of Opexa. "We are extremely disappointed that the Abili-T trial did not meet the predefined endpoints, and we are evaluating strategic alternatives for the Company in order to determine the best path forward." On October 28, 2016, Opexa announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna did show a favorable safety and tolerability profile. Further details surrounding the Abili-T trial results can be found in Opexa's 3rd Quarter Form 10-Q, filed this morning with the Securities and Exchange Commission. Opexa is currently analyzing the complete data set from the Abili-T trial. However, based on the top-line results, it is unlikely that the Company will continue with further development of Tcelna. The Company is conducting a review of its other research and development programs, including the preclinical program for OPX-212 in neuromyelitis optica (NMO), to assess the viability of continuing to pursue one or more of these programs. On November 2, 2016, Opexa announced a reduction in workforce of 40% of the Company's then 20 full-time employees while the Company evaluates its programs and various strategic alternatives in light of the disappointing Abili-T study data. The Company estimates that it will incur incremental aggregate cash charges of approximately $95,000 associated with workforce reduction. The Company expects that additional restructuring will occur by year-end. On November 2, 2016, Opexa announced that the Company had accepted the resignations of Ms. Donna Rill, Opexa's Chief Development Officer, and Mr. Scott Seaman, a member of Opexa's Board of Directors. Financial Results for the Quarter Ended September 30, 2016 Cash position: Cash and cash equivalents were $5,814,300 as of September 30, 2016, compared to $12,583,764 as of December 31, 2015. As of September 30, 2016, the Company had accounts payable and accrued expenses of $2,121,043. R & D Expense: Research and development expenses were $2,165,728 for the three months ended September 30, 2016, compared with $2,420,220 for the three months ended September 30, 2015. The decrease in expenses is primarily due to cost reductions in connection with the winding down of the clinical trial of Tcelna in SPMS, including site expenses as well as additional expense reduction due to a pause in NMO study development cost. Additionally, there was a decrease in legal patent protection expenses, and the March 2016 workforce reduction further reduced third quarter expenses. These reductions were almost completely offset by the increase in monthly expenses to Pharmaceutical Research Associates, Inc. (PRA), as well as an execution payment and additional milestone payments relating to an amendment entered into for a change order relating to the clinical trials management services agreement for the Abili-T study. G & A Expense: General and administrative expenses were $512,727 for the three months ended September 30, 2016, compared with $1,023,848 for the three months ended September 30, 2015. Net loss: Net loss reported for the three months ended September 30, 2016 was approximately $2.0 million, or $0.28 loss per share (basic and diluted), compared with a net loss of approximately $2.8 million or $0.42 loss per share (basic and diluted) for the three months ended September 30, 2015. Based on the current activities of the Company and projected burn, Opexa believes it has sufficient liquidity to support current activities in winding down the Abili-T trial and for general operations to sustain the Company and support such activities into the first quarter of 2017. For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC. Opexa Therapeutics is a biopharmaceutical company developing personalized immunotherapies based on ImmPath®, its proprietary T-cell technology, with the potential to treat autoimmune diseases. Opexa's staff of cell therapy experts operates in a stand-alone facility located on one acre in the Woodlands, Texas. The facility is comprised of over 10,000 sq. ft. of state of the art space for cGMP manufacturing suites, a quality control laboratory, a research and development laboratory, quality assurance, specialized flow cytometry, a microscopy lab and clinical and regulatory affairs, as well as warehouse space for materials management. Opexa's patent estate is currently comprised of over 160 issued patents (domestic and international). For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO or LinkedIn. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 Statements contained in this report, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the continued development of Tcelna or NMO or any other drug candidate and the Company's evaluation of its research and development programs, the Company's evaluation of various strategic alternatives, the anticipation of additional workforce restructuring, the anticipated current and future reduction in operating expenses and cash conservation benefits associated therewith, and the future charges expected to be incurred, and the sufficiency of the Company's resources, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with the Company's ability to raise additional capital to continue any of its development programs and support its operations, whether the Company continues development of Tcelna, OPX-212 or any of its other research and development programs, possible changes in the magnitude or timing of the planned workforce reduction, including as a result of changes that may occur in the Company's operations or operating plan, or other reasons or events, possible changes in the amount of charges and cash payments associated with the workforce reduction, including the possibility that the Company may incur unanticipated charges or make cash payments that are not currently contemplated, the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of the workforce reduction or any other cost-cutting measures that are implemented, the ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.


News Article | November 15, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Secondary Progressive Multiple Sclerosis (SPMS), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Secondary Progressive Multiple Sclerosis (SPMS) and features dormant and discontinued projects. Report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. - The report provides a snapshot of the global therapeutic landscape of Secondary Progressive Multiple Sclerosis (SPMS) - The report reviews pipeline therapeutics for Secondary Progressive Multiple Sclerosis (SPMS) by companies and universities/research institutes based on information derived from company and industry-specific sources - The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages - The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved Secondary Progressive Multiple Sclerosis (SPMS) therapeutics and enlists all their major and minor projects - The report assesses Secondary Progressive Multiple Sclerosis (SPMS) therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type - The report summarizes all the dormant and discontinued pipeline projects - The report reviews latest news related to pipeline therapeutics for Secondary Progressive Multiple Sclerosis (SPMS) - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of therapeutics under development for Secondary Progressive Multiple Sclerosis (SPMS) - Identify potential new clients or partners in the target demographic - Develop strategic initiatives by understanding the focus areas of leading companies - Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics - Devise corrective measures for pipeline projects by understanding Secondary Progressive Multiple Sclerosis (SPMS) pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline


THE WOODLANDS, TX / ACCESSWIRE / May 12, 2017 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today reported financial results for the quarter ended March 31, 2017, and provided an update on the Company's recent corporate developments. "The first quarter saw us continuing with our analysis and progress of identifying and advancing on strategic options for the Company, following the announcement last quarter of disappointing results from the Phase 2b clinical trial of our lead product candidate Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS)," said Neil K. Warma, President and Chief Executive Officer of Opexa. "We have been focused on defining an appropriate path forward for the Company, as well as managing our cash during this process. As previously reported, Opexa was able to eliminate the liabilities for the ongoing operation of its facility and equipment by assigning the facility and equipment leases to KBI Biopharma in the first quarter." Financial Results for the Quarter Ended March 31, 2017 For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 Statements contained in this news release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the continued development of Tcelna or NMO or any other drug candidate and the Company's evaluation of its research and development programs, the Company's evaluation of various strategic options or alternatives, the anticipated reduction in operating expenses and cash conservation benefits associated with recent workforce reductions, the elimination of future lease liabilities and the sufficiency of the Company's resources, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with the Company's ability to raise additional capital to continue any of its development programs and support its operations, whether the Company continues development of Tcelna, OPX-212 or any of its other research and development programs, the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of recent workforce reductions and other cost-cutting measures that are implemented, the ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.


News Article | May 8, 2017
Site: www.prnewswire.com

The research will be led by Dr Jeremy Chataway, UCL Institute of Neurology, London, who led the phase 2 trial of simvastatin involving 140 people with SPMS that was published in The Lancet in 2014. The research found those taking high doses of simvastatin had a significant reduction in the rate of brain atrophy (brain shrinkage) over two years, and also had better disability and quality of life scores at the end of the study. "This drug holds incredible promise for the thousands of people living with secondary progressive MS in the U.K., and around the world, who currently have few options for treatments that have an effect on disability," said Chataway. "This study will establish definitively whether simvastatin is able to slow the rate of disability progression over a three year period, and we are very hopeful it will." Bruce Bebo, Executive Vice President, Research for the National MS Society said, "We are very pleased to be a partner in the public-private funding syndicate that was forged to support a phase 3 clinical trial of a repurposed, generic therapy for people with SPMS, for whom there are few treatment choices." Susan Stellmacher, 62, of Minneapolis lives with SPMS. "I think it's absolutely exciting news," she said. "There has been nothing for me…so to think that something so widely available and more affordable is possible -- that's exciting." The trial will involve 1180 people with SPMS across the U.K. It will take six years to complete. The trial will cost a total of nearly $7 million, with research costs of: For more information about MS and the National MS Society: www.nationalmssociety.org To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/multi-million-dollar-trial-to-investigate-if-statins-could-become-ms-treatment-300453573.html


THE WOODLANDS, TX / ACCESSWIRE / May 12, 2017 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today reported financial results for the quarter ended March 31, 2017, and provided an update on the Company's recent corporate developments. "The first quarter saw us continuing with our analysis and progress of identifying and advancing on strategic options for the Company, following the announcement last quarter of disappointing results from the Phase 2b clinical trial of our lead product candidate Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS)," said Neil K. Warma, President and Chief Executive Officer of Opexa. "We have been focused on defining an appropriate path forward for the Company, as well as managing our cash during this process. As previously reported, Opexa was able to eliminate the liabilities for the ongoing operation of its facility and equipment by assigning the facility and equipment leases to KBI Biopharma in the first quarter." On February 1, 2017, Opexa entered into an assignment and assumption of lease with KBI Biopharma, Inc. for Opexa's 10,200 square foot corporate headquarters facility located in The Woodlands, Texas, and a related assignment of a lease on a major piece of equipment. Opexa also sold certain furniture, fixtures and equipment, as well as its laboratory supplies, located at its corporate headquarters to KBI for a lump sum cash consideration. On January 31, 2017, Opexa implemented a reduction of its workforce by terminating the employment of seven full-time employees, incurring costs of approximately $219,000 associated with this workforce reduction. In addition to assessing strategic options, the Company is conducting a review of its research and development programs other than Tcelna, including its preclinical program for OPX-212 for the treatment of neuromyelitis optica (NMO), to assess the viability of continuing to pursue one or more of these programs. Financial Results for the Quarter Ended March 31, 2017 Cash position: Cash and cash equivalents were $2,822,677 as of March 31, 2017, compared to $3,444,952 as of December 31, 2016. R & D Expense: Research and development expenses were $206,024 for the three months ended March 31, 2017, compared with $1,829,062 for the three months ended March 31, 2016. The decrease in expenses is primarily due to cost reductions in connection with the winding down of the clinical trial of Tcelna in SPMS, including our site expenses as well as additional expense reduction due to a pause in NMO study development cost. Additionally, expenses were further reduced due to the workforce reductions over the past year. The reduction in expense was slightly offset by the severance accrual for our former Chief Scientific Officer. G & A Expense: General and administrative expenses were $719,869 for the three months ended March 31, 2017, compared with $987,248 for the three months ended March 31, 2016. The decrease in expenses is primarily due to the workforce reduction over the past year as well as a reduction in rent and property taxes. These reductions were slightly offset by an increase in professional services and no reallocation of general and administrative expenses to research and development. Net loss: We had a net loss for the three months ended March 31, 2017 of $926,272, or $0.12 loss per share (basic and diluted), compared with a net loss of approximately $2.2 million or $0.31 loss per share (basic and diluted) for the three months ended March 31, 2016. For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 Statements contained in this news release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the continued development of Tcelna or NMO or any other drug candidate and the Company's evaluation of its research and development programs, the Company's evaluation of various strategic options or alternatives, the anticipated reduction in operating expenses and cash conservation benefits associated with recent workforce reductions, the elimination of future lease liabilities and the sufficiency of the Company's resources, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with the Company's ability to raise additional capital to continue any of its development programs and support its operations, whether the Company continues development of Tcelna, OPX-212 or any of its other research and development programs, the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of recent workforce reductions and other cost-cutting measures that are implemented, the ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date. THE WOODLANDS, TX / ACCESSWIRE / May 12, 2017 / Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, today reported financial results for the quarter ended March 31, 2017, and provided an update on the Company's recent corporate developments. "The first quarter saw us continuing with our analysis and progress of identifying and advancing on strategic options for the Company, following the announcement last quarter of disappointing results from the Phase 2b clinical trial of our lead product candidate Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS)," said Neil K. Warma, President and Chief Executive Officer of Opexa. "We have been focused on defining an appropriate path forward for the Company, as well as managing our cash during this process. As previously reported, Opexa was able to eliminate the liabilities for the ongoing operation of its facility and equipment by assigning the facility and equipment leases to KBI Biopharma in the first quarter." On February 1, 2017, Opexa entered into an assignment and assumption of lease with KBI Biopharma, Inc. for Opexa's 10,200 square foot corporate headquarters facility located in The Woodlands, Texas, and a related assignment of a lease on a major piece of equipment. Opexa also sold certain furniture, fixtures and equipment, as well as its laboratory supplies, located at its corporate headquarters to KBI for a lump sum cash consideration. On January 31, 2017, Opexa implemented a reduction of its workforce by terminating the employment of seven full-time employees, incurring costs of approximately $219,000 associated with this workforce reduction. In addition to assessing strategic options, the Company is conducting a review of its research and development programs other than Tcelna, including its preclinical program for OPX-212 for the treatment of neuromyelitis optica (NMO), to assess the viability of continuing to pursue one or more of these programs. Financial Results for the Quarter Ended March 31, 2017 Cash position: Cash and cash equivalents were $2,822,677 as of March 31, 2017, compared to $3,444,952 as of December 31, 2016. R & D Expense: Research and development expenses were $206,024 for the three months ended March 31, 2017, compared with $1,829,062 for the three months ended March 31, 2016. The decrease in expenses is primarily due to cost reductions in connection with the winding down of the clinical trial of Tcelna in SPMS, including our site expenses as well as additional expense reduction due to a pause in NMO study development cost. Additionally, expenses were further reduced due to the workforce reductions over the past year. The reduction in expense was slightly offset by the severance accrual for our former Chief Scientific Officer. G & A Expense: General and administrative expenses were $719,869 for the three months ended March 31, 2017, compared with $987,248 for the three months ended March 31, 2016. The decrease in expenses is primarily due to the workforce reduction over the past year as well as a reduction in rent and property taxes. These reductions were slightly offset by an increase in professional services and no reallocation of general and administrative expenses to research and development. Net loss: We had a net loss for the three months ended March 31, 2017 of $926,272, or $0.12 loss per share (basic and diluted), compared with a net loss of approximately $2.2 million or $0.31 loss per share (basic and diluted) for the three months ended March 31, 2016. For additional information please see Opexa's Quarterly Report on Form 10-Q filed today with the SEC. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 Statements contained in this news release, other than statements of historical fact, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words "expects," "believes," "may," "intends," "potential," "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the continued development of Tcelna or NMO or any other drug candidate and the Company's evaluation of its research and development programs, the Company's evaluation of various strategic options or alternatives, the anticipated reduction in operating expenses and cash conservation benefits associated with recent workforce reductions, the elimination of future lease liabilities and the sufficiency of the Company's resources, constitute forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation risks and uncertainties associated with the Company's ability to raise additional capital to continue any of its development programs and support its operations, whether the Company continues development of Tcelna, OPX-212 or any of its other research and development programs, the Company's ability to reduce its operating expenses and conserve cash on a net basis as a result of recent workforce reductions and other cost-cutting measures that are implemented, the ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. All forward-looking statements contained in this report speak only as of the date on which they were first made by the Company, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date.


SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from three Phase III studies of its investigational medicine OCREVUS™ (ocrelizumab) – the OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ORATORIO study in primary progressive multiple sclerosis (PPMS) – were published in the December 21, 2016 online issue of the New England Journal of Medicine (NEJM). Data from the OCREVUS Phase III studies showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif® (interferon beta-1a) in RMS and with placebo in PPMS. The primary endpoint was met in all three studies, which includes relative reduction of annualized relapse rate in the RMS studies and relative reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study. Key secondary endpoints in all three studies were also met, including multiple measures of disability progression and brain lesion activity. “These publications that indicate that B cells play a central role in MS are the result of a longstanding collaboration between the scientific community and industry for the benefit of people with MS,” said Stephen Hauser, M.D., Chair of the Scientific Steering Committee of the OPERA studies, Director of the Weill Institute for Neurosciences and Chair of the Department of Neurology at the University of California, San Francisco. “In the OPERA I and OPERA II RMS studies, OCREVUS consistently and significantly reduced disease activity and disability progression compared with a standard-of-care high-dose interferon while demonstrating a favorable safety profile. The consistency of these pioneering data, the effect seen in these clinical studies and the favorable safety profile may support treating MS earlier with a high-efficacy disease-modifying medicine.” Data from two identical studies (OPERA I and OPERA II) in RMS showed OCREVUS was superior to high-dose Rebif (interferon beta-1a), a well-established MS therapy, in reducing three major markers of disease activity: relapses (primary endpoint), disability progression and brain lesion activity over the two-year controlled treatment period. In a separate PPMS study (ORATORIO), OCREVUS significantly reduced the risk of confirmed disability progression sustained for at least 12 weeks (primary endpoint) and 24 weeks (a key secondary endpoint) compared with placebo. OCREVUS treatment was also superior to placebo on other key measures of disease progression in PPMS patients including the time required to walk 25 feet, the volume of chronic brain lesions and brain volume loss. “OCREVUS is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” said Xavier Montalban, M.D., Ph.D., Chair of the Scientific Steering Committee of the ORATORIO study and Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for OCREVUS mark an important step in our understanding of this highly disabling form of the disease.” The OCREVUS safety profile was evaluated in the three Phase III studies. In the RMS studies, the proportion of patients with serious adverse events and serious infections was similar between the OCREVUS and interferon beta-1a treatment groups. In the PPMS study, the proportion of patients with adverse events and serious adverse events was similar between the OCREVUS and placebo treatment groups. Safety analyses continue in the open-label extension studies in both RMS and PPMS. Marketing applications for OCREVUS, submitted for RMS and PPMS, have been accepted and are currently under review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). As previously announced, OCREVUS was granted Priority Review Designation by the FDA with a targeted action date of March 28, 2017. OCREVUS™ is the proprietary name submitted to the FDA for the investigational medicine ocrelizumab. About the OPERA I and OPERA II studies in RMS OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses. The primary and key secondary endpoints were previously presented at the 2015 congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Data from the Phase III OPERA studies in patients with RMS showed: As previously reported at the 2016 American Academy of Neurology Annual Meeting (AAN), OCREVUS increased the proportion of patients who achieved no evidence of disease activity (NEDA) by 64 percent and 89 percent compared with interferon beta-1a at 96 weeks in OPERA I and OPERA II, respectively (p<0.001 and p<0.001). The exploratory endpoint is based on a combination of three major markers of disease activity (relapses, disability progression and inflammatory and chronic MRI activity) and provides a more comprehensive measurement of disease activity and the effect of treatment than any single endpoint. Overall, the proportion of patients in the OCREVUS group with adverse events was similar to interferon beta-1a in both studies (80.1 percent in the OCREVUS group vs. 80.9 percent in the interferon beta-1a group in OPERA I and 86.3 percent in the OCREVUS group vs. 85.6 percent in the interferon beta-1a group in OPERA II); the most common adverse event associated with OCREVUS was infusion-related reactions (34.3 percent of patients who received OCREVUS experienced at least one infusion-related reaction vs. 9.9 percent for interferon beta-1a). The proportion of patients in the OCREVUS group with serious adverse events, including serious infections, was also similar to interferon beta-1a (6.9 percent in the OCREVUS group vs. 7.8 percent in the interferon beta-1a group in OPERA I and 7.0 percent in the OCREVUS group vs. 9.6 percent in the interferon beta-1a group in OPERA II). About the ORATORIO study in PPMS ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with PPMS. In contrast to the OPERA I and OPERA II studies, where the blinded treatment period was two years, the blinded treatment period of the ORATORIO study continued beyond that until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study. The primary and key secondary endpoints were previously presented at the 2015 congress of ECTRIMS. Data from the Phase III ORATORIO study in patients with PPMS showed: Overall, the proportion of patients in the OCREVUS group with adverse events was similar to placebo (95.1 percent vs. 90.0 percent, respectively); the most common adverse event associated with OCREVUS was infusion-related reactions (39.9 percent vs. 25.5 percent for placebo). The proportion of patients in the OCREVUS group with serious adverse events, including serious infections, was also similar to placebo (20.4 percent vs. 22.2 percent, respectively). OCREVUS is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved. Multiple sclerosis (MS) is a chronic disease that affects an estimated 400,000 people in the U.S., for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. Approximately 95 percent of people with MS have a relapsing form or primary progressive MS at diagnosis. Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Over time, some people with RRMS experience steadily worsening symptoms and transition to secondary progressive MS (SPMS), with or without relapses. Disease activity and progression can occur even when people do not show signs or symptoms of MS, despite available relapsing MS treatments. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 10-15 percent of people with MS are diagnosed with the primary progressive form of the disease. There are no approved treatments for PPMS. Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism. Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. All trademarks used or mentioned in this release are protected by law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.


News Article | February 21, 2017
Site: www.prnewswire.co.uk

ATX-MS-1467 Reduced the Number and Volume of Brain Lesions With a Very Promising Safety Profile Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, announces positive results from the Phase IIa clinical study of its lead product candidate, ATX-MS-1467, for the treatment of patients with multiple sclerosis. The Phase IIa, open-label, one arm study evaluated the effects of ATX-MS-1467 in 19 patients with relapsing multiple sclerosis. The investigational product was administered intradermally (ID) every 2 weeks for 20 weeks. Following a dose titration of 50 and 200 μg in the initial 4 weeks of treatment a dose of 800μg was administered fortnightly for a further of 16 weeks. There were statistically significant reductions in total and new T1 Gadolinium enhancing lesions measured using MRI during treatment as well as a significant reduction in the volume of T1 Gadolinium enhancing lesions. The data also showed a strong trend towards improvement in the Multiple Sclerosis Functional Composite (MSFC) score that is used clinically as an indicator of improvement in disability. There were no treatment related serious adverse events and the adverse event profile was mild. Dr Keith Martin, Chief Executive Officer of Apitope, commented, "We are delighted with these positive results that confirm both clinical findings in our Phase Ib trial as well as preclinical results showing significant decreases in MRI detected lesions and disability in a standard multiple sclerosis model. We will continue to progress the development of ATX-MS-1467 as a treatment for multiple sclerosis and are currently preparing for a Phase IIb placebo controlled study to demonstrate clinical efficacy." Dr Jeremy Chataway, Consultant Neurologist, National Hospital for Neurology and Neurosurgery, London, commenting on the results said, "Having been the Chief Investigator on the previous Phase Ib study, it is pleasing to see these promising confirmatory Phase IIa results where ATX-MS-1467 has shown both an encouraging efficacy and an excellent safety and tolerability profile. While these patients were only treated for 20 weeks, results in a Phase IIb study with a longer treatment period will be interesting." The compound had previously completed a Phase I clinical study in six patients with secondary progressive multiple sclerosis (SPMS) and a second Phase I study in 43 relapsing multiple sclerosis patients, assessing safety and biological parameters. The latest results support the further development of ATX-MS-1467 in multiple sclerosis. Apitope is a European biotech company focused on the discovery and development of disease modifying therapies for abnormal immune responses, including autoimmune diseases such as, multiple sclerosis, Graves' disease, and uveitis; and Factor VIII intolerance. Apitope has a patented discovery platform which enables selection of disease-modifying peptide therapies for the target of interest; and has already generated a pipeline of seven programmes in clinical and preclinical development, of which the lead programme in multiple sclerosis is in Phase II. The discovery engine selects Apitopes™ - Antigen Processing Independent epiTOPES. Apitopes are soluble, synthetic peptides from the human sequence which can selectively suppress abnormal immune responses and reinstate the normal immune balance. Stakeholders in the company include Wales Life Sciences Fund, Vesalius Biocapital, LRM, the Wellcome Trust and the US MS charity, Fast Forward. Apitope's lead product candidate is ATX-MS-1467, a potentially disease-modifying therapy for the treatment of multiple sclerosis, is a novel peptide-based therapeutic identified using Apitope's proprietary technology platform. It consists of four short peptides that are derived from myelin basic protein, a key autoantigen in multiple sclerosis. It is designed to induce immunological tolerance of the body's T cells to key autoantigens thought to be involved in the pathogenesis of multiple sclerosis. For more information on the Company, please visit: www.apitope.com For further information: Apitope Dr Keith Martin, CEO Tel: +44-(0)-1291-63-55-11 keith.martin@apitope.com For media enquiries: Hume Brophy Conor Griffin, Alexia Faure, Alexander Protsenko Tel: +44-(0)-20-7862-6381 apitope@humebrophy.com


LA JOLLA, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the external Data and Safety Monitoring Board (DSMB) for the ongoing Phase 2b clinical trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS) has reviewed the results of the interim efficacy analysis and made the recommendation to the NIH National Institute of Neurological Diseases and Stroke (NINDS) that the trial should continue as planned and this recommendation was accepted by NINDS.  Dr. Robert Fox at the Cleveland Clinic, the principal investigator of this ongoing NIH-funded Phase 2b clinical trial, commented, "We are very pleased that this important study will continue as planned and we believe this is an encouraging sign.  The unmet medical need for progressive MS patients is extremely high as there is no treatment approved for long-term use for these patients." Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, "We are very pleased to have successfully completed the interim analysis which included a futility analysis.  As the progressive MS study will now continue as planned, we look forward to providing further updates as we receive results of final data analysis from the study, which are expected in the second half of 2017.” The Phase 2 Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28 enrolling clinical sites across the U.S. and is designed to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) administered twice daily to subjects with primary progressive or secondary progressive multiple sclerosis (PPMS or SPMS, respectively).  255 qualifying subjects were randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of up to 100 mg/day (50 mg twice daily). The progressive MS subjects may be either untreated with long-term disease modifying therapy (DMT) or may continue either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization was controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study are to 1) evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF) and 2) evaluate the safety and tolerability of ibudilast (MN-166) versus placebo administered orally in subjects with PPMS or SPMS. Secondary measures include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain. Exploratory objectives include pharmacokinetic and biomarker analyses. The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS's Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS’s existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for the network is based at Massachusetts General Hospital and the data coordinating center is at the University of Iowa. Principal Investigator Dr. Robert Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society is providing patient advocate input and trial enrollment awareness. MediciNova holds the trial IND with the FDA’s Division of Neurology Products and provides scientific and analytical support, as well as drug and placebo supply. According to the National MS Society, MS affects approximately 2.3 million people worldwide. Approximately 85% of MS patients are initially diagnosed with relapsing remitting MS (RRMS). Most RRMS patients will eventually transition into SPMS in which there are fewer or no relapses but gradual worsening of health. Approximately 10% of MS patients are diagnosed with PPMS at onset and exhibit increasing disabilities in walking, vision, mental acuity, and other bodily functions that are typical in both PPMS and SPMS without ever experiencing relapses or remissions. Current therapies for MS affect the inflammatory response, but provide limited benefit for neurodegeneration and/or brain tissue repair. There is an unmet medical need for agents that may provide neuroprotection. MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS and substance abuse/addiction. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast's anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain.  MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction. MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova's current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive MS, ALS and substance dependence (e.g. alcohol use disorder, methamphetamine dependence, opioid dependence) and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF).  MediciNova’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers.  MediciNova is engaged in strategic partnering and other potential funding discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2015 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.


Baldinozzi G.,SPMS | Muller G.,CNRS Laboratory of Condensed Matter Chemistry, Paris | Laberty-Robert C.,CNRS Laboratory of Condensed Matter Chemistry, Paris | Gosset D.,SPMS | And 2 more authors.
Journal of Physical Chemistry C | Year: 2012

Nanocrystals growth mechanism embedded into mesoporous thin films has been determined directly from grazing incidence X-ray diffraction data. We have shown, for the first time, that surface capillary forces control the growth mechanism of nanocrystals into these nanoarchitectures. Moreover, these data allow an estimation of the surface tension of the nanocrystals organized into a 3-D nanoarchitecture. The analysis of the variations in the strain field of these nanocrystals gives information on the evolution of the microstructure of these mesoporous films, that is, the contacts among nanocrystals. This work represents the first application of grazing incidence X-ray for understanding stability and performances of mesoporous thin films. This approach can be used to understand the structural stability of these nanoarchitectures at high temperature. © 2012 American Chemical Society.

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