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News Article | July 25, 2017
Site: www.prnewswire.com

The Microsoft Devices Partner of the Year Special Recognition Awards are given to global enterprise and medium business partners who have demonstrated outstanding leadership in delivering Microsoft devices solutions to mutual customers in the past year. SYNNEX stood out for significantly increasing its number of reseller partners and launching of a Certified Pre-Owned Devices Program, among other accomplishments. "We are honored to receive this recognition, which verifies how our resellers continue to benefit from the robust system SYNNEX has built around the Microsoft Surface portfolio," said Rob Moyer, Vice President, Cloud, Mobility and Software Solutions, SYNNEX Corporation. "Targeted vertical alignment and unparalleled support have fostered continual success for our customers and Microsoft." "Over the past year, SYNNEX has done an excellent job in developing and growing the Surface Hub and Surface Tablet businesses in the U.S., Canada and Japan," said Paul Muckleston, General Manager for Worldwide Commercial Surface Channels, Microsoft. "We look forward to our continued relationship." The input for the awards is provided by the Microsoft worldwide field, partner regional leaders, and the Microsoft Corporate Business Groups team. For more information about Microsoft through SYNNEX, visit www.synnexcorp.com/microsoft/. To learn more about SYNNEX Corporation, visit www.synnex.com. About SYNNEX SYNNEX Corporation (NYSE: SNX) is a Fortune 500 corporation and a leading business process services company, providing a comprehensive range of distribution, logistics and integration services for the technology industry and providing outsourced services focused on customer engagement strategy to a broad range of enterprises. SYNNEX distributes a broad range of information technology systems and products, and also provides systems design and integration solutions. Concentrix, a wholly-owned subsidiary of SYNNEX Corporation, offers a portfolio of strategic solutions and end-to-end business services around customer engagement strategy, process optimization, technology innovation, front and back-office automation and business transformation to clients in ten identified industry verticals. Founded in 1980, SYNNEX Corporation operates in numerous countries throughout North and South America, Asia-Pacific and Europe. Additional information about SYNNEX may be found online at www.synnex.com. About Inspire Formerly called the Microsoft Worldwide Partner Conference (WPC), Inspire is an annual, global convergence of Microsoft's top partners. It provides partners with the opportunity to network, drive business growth and identify new profitability opportunities. This year at Microsoft Inspire, Microsoft will continue to focus on key trends that represent the most profitable models for partners. Safe Harbor Statement Statements in this release that are forward-looking, such as general success of the collaboration, involve known and unknown risks and uncertainties, which may cause the Company's actual results in future periods to be materially different from any future performance that may be suggested in this release. The Company assumes no obligation to update any forward-looking statements contained in this release. Copyright 2017 SYNNEX Corporation. All rights reserved. SYNNEX, the SYNNEX Logo, CONCENTRIX, and all other SYNNEX company, product and services names and slogans are trademarks or registered trademarks of SYNNEX Corporation. SYNNEX, the SYNNEX Logo and CONCENTRIX Reg. U.S. Pat. & Tm. Off. Other names and marks are the property of their respective owners.


News Article | July 31, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today provided an update on the progress of the company’s INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury), which is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete thoracic spinal cord injury (SCI). The primary endpoint of the study is defined as improvement in ASIA Impairment Scale (AIS) grade from baseline at the six-month visit. The study update includes: One of the two patients who recently converted was implanted with the Neuro-Spinal Scaffold™ in January 2017 by Travis Dumont, M.D, Director of the Neurovascular Program and Principal Investigator at Banner – University Medical Center Tucson in Tucson, AZ. This patient initially converted from complete AIS A SCI to sensory incomplete AIS B SCI at two months but reverted back to AIS A at three months. Subsequently, at the six-month visit, the patient converted from AIS A to AIS B. This conversion to AIS B at six months will be included in the primary endpoint analysis of AIS improvements from baseline at the six-month visit. Dr. Dumont said, “This patient has demonstrated motor improvements from baseline assessments, and the conversion to AIS B at the six-month visit is encouraging.” The other patient who recently converted was implanted in June 2017 by Drs. Dan Altman, Nestor Tomycz, and Terrence Julien at Allegheny General Hospital in Pittsburgh, PA. The patient converted from complete AIS A SCI to motor incomplete AIS C SCI between the hospital discharge and one-month visits. At baseline, the patient was assessed to have a T6 neurological level of injury (NLI). In a large European registry*, only 2.9% of patients with a T6-T9 NLI were reported to improve to AIS C or better by one month after injury. This is the second patient in the INSPIRE study to have reached AIS C motor incomplete classification at the one-month evaluation and the fourth patient in the INSPIRE study to have reached AIS C motor incomplete classification. Dr. Julien, System Co-Director of Minimally Invasive Spine Surgery and Principal Investigator, said, “A conversion to AIS C at one month for a patient with a T6 level of injury is rare. I look forward to continuing to track the patient’s progress and hope that the patient continues to show signs of neurological recovery.” The most recent patient to enroll into the INSPIRE study, who was implanted in late June 2017, passed away suddenly at a rehabilitation facility following discharge from the hospital. The cause of death was deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold™ or implantation procedure. This represents the third death in INSPIRE to date, all of which have been deemed to be unrelated to the investigational product or implantation procedure by each respective site’s Principal Investigators. The company has elected, based in part on discussions with the company’s independent Data Safety Monitoring Board, to implement a temporary halt to enrollment as it engages with the Food and Drug Administration (FDA) to determine whether any changes to patient enrollment criteria related to patients who may have a higher mortality risk or other study modifications are deemed necessary. As a result of the temporary enrollment halt, the company anticipates completing INSPIRE enrollment in the first half of 2018 and submitting a Humanitarian Device Exemption (HDE) application in the second half of 2018. Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “Our thoughts and condolences are with the patient’s loved ones at this difficult time. We remain committed to monitoring carefully all aspects of the INSPIRE study to ensure the ongoing safety of subjects. Regarding the enrollment halt, we are working toward an expeditious resolution. Based on the compelling clinical results to date, particularly the two most recent AIS conversions, we hope to reopen enrollment as soon as possible.” The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110. Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold™ within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold™, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882. InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™ received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect," “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold™ and the status of the clinical program, including the timing for enrollment and completion of the INSPIRE Study and submission of an HDE application to the FDA. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.


NEWTOWN, Pa., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes, today announced that the Company will release its second quarter 2017 financial results on August 14, 2017 after the market closes. The Company will host a conference call to discuss these results on August 15, 2017 at 9:00 a.m. Eastern Time. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID 48705257. The call will also be webcast live at:  http://investor.onconova.com/events.cfm. A replay will be available at that link until November 30, 2017. Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Rigosertib, Onconova's lead candidate, is a proprietary Phase 3 small molecule agent, which  the Company believes blocks cellular signaling by targeting RAS effector pathways.  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. Advanced clinical trials with the Company’s  lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit http://www.onconova.com. The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease,  provides long duration of exposure, and ensures dosing under a controlled setting. The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the  U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial.  INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib.  Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028. Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.'s future operations, clinical development of Onconova's product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova's cash and other resources to fund operating expenses and capital expenditures, Onconova's anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova's ability to continue as a going concern, the need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of Onconova's clinical trials and regulatory approval of protocols, and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.


The 2017 categories for IMPACT Awards reflect areas in which Microsoft is growing and transforming. Finalists and winners have shown a proven commitment to Microsoft by delivering outstanding performances. The SMB Cloud Productivity Innovation Partner of the Year Award demonstrates SYNNEX' success in growing its cloud solutions business in the highly competitive Canadian market. SYNNEX Canada was also the IMPACT Award finalist for SMB Partner of the Year. "Our relationship with Microsoft brings the best solutions to customers looking for a competitive advantage as cloud becomes increasingly important in every aspect of their businesses," said Mitchell Martin, President, SYNNEX Canada Limited. "We are honored to be acknowledged for our accomplishments within Microsoft's Canadian partner community through this award." "The IMPACT Awards recognize Microsoft's community of partners, system integrators and service providers who are committed to the pursuit of quality and innovation," said Jason Brommet, Commercial Channel Lead, Microsoft Canada. "In this mobile-first, cloud-first era, the work that SYNNEX is doing to help small and mid-sized businesses innovate and digitally transform is more important than ever." Microsoft's IMPACT Awards recognize the outstanding work of Canadian partners who lead the way in the pursuit of excellence and show confidence and commitment to the relationship by leveraging Microsoft cloud offerings. For more information about Microsoft through SYNNEX Canada, contact microsoftCSPCanada@synnex.com. For more information about Microsoft through SYNNEX, visit www.synnexcorp.com/microsoft/. To learn more about SYNNEX Canada Limited, visit www.synnex.ca. About SYNNEX SYNNEX Corporation (NYSE: SNX), is a Fortune 500 corporation and a leading business process services company, providing a comprehensive range of distribution, logistics and integration services for the technology industry and providing outsourced services focused on customer engagement strategy to a broad range of enterprises. SYNNEX distributes a broad range of information technology systems and products, and also provides systems design and integration solutions. Concentrix, a wholly-owned subsidiary of SYNNEX Corporation, offers a portfolio of strategic solutions and end-to-end business services around customer engagement strategy, process optimization, technology innovation, front and back-office automation and business transformation to clients in ten identified industry verticals. Founded in 1980, SYNNEX Corporation operates in numerous countries throughout North and South America, Asia-Pacific and Europe. Additional information about SYNNEX may be found online at www.synnex.com. About Inspire Formerly called the Microsoft Worldwide Partner Conference (WPC), Inspire is an annual, global convergence of Microsoft's top partners. It provides partners with the opportunity to network, drive business growth and identify new profitability opportunities. This year at Microsoft Inspire, Microsoft will continue to focus on key trends that represent the most profitable models for partners. About Microsoft Canada Established in 1985, Microsoft Canada Inc. is the Canadian subsidiary of Microsoft Corporation the worldwide leader in software, services and solutions that help people and businesses realize their full potential. Microsoft Canada provides nationwide sales, marketing, consulting and local support services in both French and English. Headquartered in Mississauga, Microsoft Canada has nine regional offices across the country dedicated to empowering people through great software - any time, any place and on any device. For more information on Microsoft Canada, please visit www.microsoft.ca. Safe Harbor Statement Statements in this release that are forward-looking, such as general success of the collaboration, involve known and unknown risks and uncertainties, which may cause the Company's actual results in future periods to be materially different from any future performance that may be suggested in this release. The Company assumes no obligation to update any forward-looking statements contained in this release. Copyright 2017 SYNNEX Corporation. All rights reserved. SYNNEX, the SYNNEX Logo, CONCENTRIX, and all other SYNNEX company, product and services names and slogans are trademarks or registered trademarks of SYNNEX Corporation. SYNNEX, the SYNNEX Logo and CONCENTRIX Reg. U.S. Pat. & Tm. Off. Other names and marks are the property of their respective owners.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today provided a general business update and reported financial results for the quarter ended June 30, 2017. Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the second quarter, we continued to make significant progress at InVivo. During the quarter, we enrolled four more patients into INSPIRE, and we now have 16 patients in follow-up. One of these patients improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. We also announced that two patients who had previously converted to AIS B had been assessed to have converted to AIS C at their 12- and 24-month visits, respectively. Of the seven total AIS grade conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. Given these AIS C conversions and an overall conversion rate of 54.5% (6/11) at the 6-month primary endpoint visit, we remain enthusiastic about the potential of establishing the Neuro-Spinal Scaffold™ as the foundation of a new standard of care for acute spinal cord injury. “Last week, we announced that the most recent patient to enroll into the INSPIRE study passed away with the cause of death deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold™ or implantation procedure. This was the third death in the INSPIRE study. Following discussions with the company’s independent Data Safety Monitoring Board (DSMB), we elected to implement a temporary halt to enrollment as we engaged with the FDA to determine whether any changes to the protocol were needed. The FDA responded formally with its recommendations; we are working on assessing the recommendations and formulating a response that will include a protocol amendment. At this time, our primary focus at InVivo is re-opening enrollment in INSPIRE as quickly as possible so that we can continue to make progress toward our goal of redefining the life of the spinal cord injury patient.” For the three-month period ended June 30, 2017, the Company reported a net loss of approximately $6.3 million, or $0.20 per diluted share, compared to a net loss of $5.2 million, or $0.16 per diluted share, for the three-month period ended June 30, 2016. The results for the three-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $416,000 in research and development and $724,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $554,000 for the three-month period ended June 30, 2017 reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended June 30, 2017 was $6.9 million, or $0.22 per diluted share, compared to adjusted net loss of $5.8 million, or $0.18 per diluted share, for the three-month period ended June 30, 2016. The Company ended the quarter with $21.8 million of cash, cash equivalents, and marketable securities. For the six-month period ended June 30, 2017, the Company reported a net loss of approximately $12.7 million, or $0.40 per diluted share, compared to a net loss of $11.8 million or $0.39 per diluted share, for the six-month period ended June 30, 2016. The results for the six-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $1.2 million in research and development and $1.0 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $795,000 for the six-month period ended June 30, 2017 reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the six-month period ended June 30, 2017 was $13.5 million, or $0.42 per diluted share, compared to adjusted net loss of $11.4 million, or $0.37 per diluted share, for the six-month period ended June 30, 2016. Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the derivative warrant liability. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the Company's operations, on a period-to-period comparable basis, with financial amounts both including and excluding the identified items. The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110. Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold™ within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold™, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882. InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™ received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect," “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold™ and the status of the clinical program, including the changes to the INSPIRE protocol, the timing for re-opening enrollment in the INSPIRE Study and the submission of an HDE application to the FDA. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended June 30, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.


News Article | July 11, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that James Cook University Hospital in Middlesbrough, United Kingdom has been added as the UK’s first clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. The Golden Jubilee Regional Spinal Cord Injuries Centre located at the James Cook University Hospital, a major trauma center, focuses exclusively on patients with spinal cord injuries and is one of eight specialist centers within England. “I am enthusiastic about the opportunity to be joining the INSPIRE study and I look forward to helping InVivo evaluate this exciting experimental technology while bringing awareness of the study to the United Kingdom,” Dr. Prasad said. Mark Perrin, InVivo’s CEO and Chairman, said, “We are thrilled to open our first INSPIRE site in the United Kingdom and are looking forward to working with Dr. Prasad and the staff at James Cook University Hospital. The INSPIRE Study is now open for enrollment across three countries: the United States, Canada, and the United Kingdom.” There are now 33 clinical sites participating in the clinical study: The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110. Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882. InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect," “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that data from the Christopher & Dana Reeve Foundation NACTN Registry will be included in the Contemporary Thoracic SCI Registry Study (now called the “CONTEMPO Registry Study”), a complement to the ongoing INSPIRE study of the Neuro-Spinal Scaffold™. The CONTEMPO Registry Study is intended to provide comprehensive natural history benchmarks for INSPIRE study results that include spinal cord injury (SCI) patients with similar baseline characteristics treated since 2006. The NACTN registry is derived from a network of academic neurosurgical departments of hospitals that have a strong focus on SCI, especially in the acute injury phase. The NACTN Registry includes acute patient data such as pre- and post-operative data, post-injury complications and treatments, MRI data, and follow-up neurological exams. Because the NACTN registry contains acute care data, it will allow for the close matching of registry patient characteristics with INSPIRE inclusion and exclusion criteria, and will be highlighted in the CONTEMPO Registry Study as a well matched natural history benchmark comparator for INSPIRE results. The CONTEMPO Registry Study will provide a robust evaluation of the recent natural history of acute, complete thoracic SCI patients across North American and European populations. InVivo has submitted a protocol for the CONTEMPO Registry Study to the U.S. Food and Drug Administration (FDA) and does not expect this study to affect clinical or regulatory timelines. InVivo believes that the combined information in the INSPIRE study and the CONTEMPO Registry Study will provide a rigorous body of evidence for the demonstration of safety and probable benefit as required by the Humanitarian Device Exemption (HDE) approval process, and plans to submit the two studies together for HDE approval. James Guest, M.D., Ph.D., a member of InVivo’s Scientific Advisory Board, a NACTN investigator, and the Principal Investigator of the CONTEMPO Registry Study, said, “The NACTN Registry was developed in large part to aid in the interpretation of SCI clinical trial results. This is the first time that the registry will be used with a partner in industry, and I believe that the registry will provide a valuable benchmark for analysis of INSPIRE results.” Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We are grateful for the care and vigilance that NACTN has put into developing an impressively thorough, curated database over many years. The inclusion of the NACTN Registry substantially increases the strength of the CONTEMPO Registry Study. We look forward to completing the INSPIRE study and the CONTEMPO Registry Study and submitting the results together in 2018 in an application for HDE approval of the Neuro-Spinal Scaffold.” A new CEO’s Perspective discussing the CONTEMPO Registry Study can be found on the InVivo Therapeutics website: http://www.invivotherapeutics.com/about-invivo/ceo-perspective/ The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. InVivo is in discussions with the FDA on this recommendation and believes that the combined information in the INSPIRE study and the CONTEMPO Registry Study will provide a rigorous body of evidence for the demonstration of safety and probable benefit as required by the HDE approval process. InVivo plans to submit the two studies together for HDE approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110. Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and carefully debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882. InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect," “designed to,” “potentially,” and similar expressions, and include statements regarding the HDE approval process, the expected impact of the Contemporary Thoracic SCI Cohort Study on clinical and regulatory timelines and the likelihood of demonstration of safety and probable benefit. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.


NEWTOWN, Pa., June 26, 2017 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), has announced data demonstrating responses of oral rigosertib with azacitidine in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), as well as oral rigosertib as a single agent. The findings were presented by Onconova, Mount Sinai, and SymBio at the 22nd Congress of the European Hematology Association taking place on June 22-24 in Madrid, Spain. “Advancing oral rigosertib in the clinic as a stand-alone agent, and providing further evidence for activity of rigosertib in combination with azacitidine in patients with MDS and AML represents an extension of our pipeline,” said Dr. Ramesh Kumar, CEO of Onconova. “We are positioned for multiple key milestones in 2017 and beyond, beginning with the interim analysis of our pivotal Phase 3 INSPIRE trial later this year.” Full copies of the posters and oral presentations  can be accessed by visiting “Scientific Presentations” in the Investors section of Onconova’s website. Oral Presentation: Oral Rigosertib Combined with Azacitidine in Patients with AML and MDS; Effects in Treatment Naive and Relapsed/Refractory Patients A novel combination therapy of oral rigosertib plus injectable azacitidine was tested in this trial (09-08) at three sites in the U.S. and Europe, representing a first-in-man study of this approach. Eight AML patients were evaluable for response, with an overall response rate (ORR) of 37.5%, and responses in both secondary and refractory AML. Two additional patients had stable disease (25%). Responses were durable, with the longest response in AML approaching one year. Among 33 evaluable MDS patients, ORR was 76%. Complete remission (CR) in eight (24%), concurrent marrow CR (mCR) and hematologic improvement (HI) in 10 (30%), mCR alone in six (18%), and HI alone in 1 (3%).  ORR was 85% in hypomethylating agent (HMA) naïve patients and 62% in HMA resistant patients. Earlier, Phase 1 and Phase 2 data in first and second-line higher risk (HR)-MDS patients were presented at the 2016 American Society of Hematology (ASH) Meeting and updated at the 2017 ASH and MDS Foundation meetings. Based on these results, the authors determined that continued study in AML is warranted. A Phase 3 study of the combination of oral rigosertib and azacitidine in patients with treatment naïve HR-MDS is currently being designed based on an end-of-phase 2 meeting with the Food and Drug Administration. E-Poster: Rigosertib Combined with Azacitidine Epigenetically Modulates Chromatin and Hematopoietic Stem Cell Populations in MDS Onconova’s collaborators from the Mount Sinai School of Medicine investigated the in vitro effects of rigosertib combined with azacitidine or vorinostat on two cell lines and on bone marrow samples from patients treated in the Phase 1-2 study, obtained prior to and after one cycle of the combination regimen. Azacitidine is an HMA and vorinostat is an inhibitor of Histone Deacetylase. Rigosertib’s mechanism of action is reported to be mediated by binding to a Ras Binding Domain present in Ras and its effector proteins, including PI3 Kinase and Raf. Chromatin remodeling by changes in methylation and acetylation were noted in cell-lines treated with all three agents, as well as after treatment with the two combinations. The nature of the changes induced with the two combinations was distinct. The authors propose that rigosertib potentially functions as a chromatin modifying agent in combination with azacitidine and may overcome HMA resistance through chromatin remodeling. Rigosertib alone, and in combination, also leads to epigenetic reprogramming of hematopoietic stem cell populations (HSPCs) that may manifest in hematological improvements in the clinical setting. A U.S. patent describing the synergistic activity of rigosertib in combination with azacitidine has been issued. SymBio, Onconova’s Partner in Japan and Korea, Presents Phase 1 data Demonstrating Oral Rigosertib as a Single Agent E-Poster: A Multicenter, Open-label, Phase 1 Clinical Study; Safety, Efficacy, and Pharmacokinetics of Oral Rigosertib in Japanese Patients with Recurrent/Relapsed or Refractory MDS A multicenter, open-label, Phase 1 clinical study of oral rigosertib (primary endpoint was dose-limiting toxicity) indicated that the recommended dose for a Phase 2 clinical study is 560 mg BID in a 2-out-of-3-week administration scheme in Japanese patients with recurrent/relapsed or refractory MDS. This regimen of oral rigosertib was well tolerated. The primary endpoint of the study was dose-limiting toxicity. The secondary endpoints were 1) safety as assessed by adverse events and laboratory results, 2) efficacy as defined by the International Working Group 2006 Criteria, and 3) pharmacokinetics. Both hematological remission rate and hematological improvement rate were 11.1% of the nine patients with a median age of 70. In this study, the recommended dose was 560 mg BID. This study and a companion Phase 1 study with IV rigosertib were designed to obtain pharmacokinetics, safety, tolerability and efficacy data in MDS patients in Japan. Currently, SymBio is enrolling patients in a pivotal Phase 3 INSPIRE global study to assess the safety and efficacy of IV rigosertib. Publication: Safety, Efficacy and Pharmacokinetics of Intravenous Rigosertib in Japanese Patients with Recurrent/Relapsed or Refractory MDS; A Multicenter, Open-label, Phase 1 Study A multicenter, open-label, Phase 1 study of intravenous rigosertib was conducted to evaluate its safety, efficacy, and pharmacokinetics and to determine the recommended dose (RD) for Japanese patients. The Phase 1 study showed that intravenous rigosertib (1,800 mg daily) for consecutive 72 hours was well-tolerated, indicating that this is the RD for Japanese patients with MDS, similar to a Phase 3 study in the U.S. Based on these clinical outcomes, Japanese patients with MDS are participating in a global randomized Phase 3 study to compare rigosertib with physicians’ choice of treatment. Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Rigosertib, Onconova's lead candidate, is a proprietary Phase 3 small molecule agent, which we believe blocks cellular signaling by targeting RAS effector pathways.  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit http://www.onconova.com. The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease,  provides long duration of exposure, and ensures dosing under a controlled setting. The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial.  INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib.  Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028. Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.'s future operations, clinical development of Onconova's product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova's cash and other resources to fund operating expenses and capital expenditures, Onconova's anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova's ability to continue as a going concern, the need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of Onconova's clinical trials and regulatory approval of protocols, and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.


NEWTOWN, Pa., Aug. 15, 2017 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), today provided a corporate update and reported financial results for the second quarter ended June 30, 2017. “We are advancing IV rigosertib in a late stage clinical trial for patients with unmet medical needs in MDS. Our Phase 3 INSPIRE trial with IV rigosertib is enrolling globally and the next milestone of interim analysis is anticipated in the fourth quarter,” said Dr. Ramesh Kumar, President and Chief Executive Officer. “After consulting with regulators in the US and Europe following Phase 1/2 data with oral rigosertib in combination with azacitidine, we are designing a Phase 3 trial in first-line higher risk MDS patients for submission under a Special Protocol Assessment," continued Dr. Kumar.  "We also believe there is interest for our pediatric RASopathies rare disease collaborative program from the National Cancer Institute, academia, and patient advocacy which we find extremely gratifying.” Oral Rigosertib in Combination with Azacitidine for 1st-line HR-MDS Expansion of Phase 1/2 Trial of Oral Rigosertib in Combination with Azacitidine Other Programs for Future Development or Partnership and Presentations New Collaborative Program in “RASopathies”: Rare Disease in Children The Company will host a conference call on August 15th at 9:00 a.m. Eastern Time to provide a corporate update and discuss second quarter financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID: 48705257. The call will also be webcast live at: A replay will be available at that link until November 15, 2017. Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Rigosertib, Onconova's lead candidate, is a proprietary Phase 3 small molecule agent, which the Company believes blocks cellular signaling by targeting RAS effector pathways.  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. The advanced clinical trial with the Company’s lead compound, rigosertib, is aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit  . The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk (HR) MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease, to provide long duration of exposure, and to ensure dosing under a controlled setting. The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the  U.S. Food and Drug Administration and European Medicines Agency and derives from the analysis of the ONTIME Phase 3 trial.  INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per the National Comprehensive Cancer Network (NCCN) Guidelines.  The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov ( ). The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib.  Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 1/2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028. Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.'s future operations, clinical development of Onconova's product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova's cash and other resources to fund operating expenses and capital expenditures, Onconova's anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova's ability to continue as a going concern, the need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of Onconova's clinical trials and regulatory approval of protocols, and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.


NEWTOWN, Pa., June 05, 2017 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), today announced the results of a Phase 2 study with rigosertib as a treatment for higher risk (HR-MDS) after failure of hypomethylating agents (HMAs). The study sought to evaluate bone marrow blast (BMBL) response to rigosertib as a surrogate for overall survival (OS) in this patient population. The results showed treatment with rigosertib resulted in a reduction in BMBL count, including complete bone marrow responses, confirming findings in earlier studies. Thus, BMBL response to rigosertib is a potential surrogate marker for improvement in overall survival in this patient population. “In this new study for HR-MDS patients after failure of HMA therapy, we are excited to confirm a correlation between blast reduction and prolongation of survival in rigosertib treated patients. These results build upon our previous findings in the ONTIME trial showing improvement in overall survival in patients with the highest risk prognostic categories after failure of HMA treatment (ASH 2014 presentation),”said Ramesh Kumar, Ph.D., President and CEO of Onconova. Rigosertib is currently being tested in a randomized, global, Phase 3 INSPIRE trial for this patient population. Study Name: Relationship of Bone Marrow Blast response to Overall Survival in a Multicenter Study of Rigosertib in Patients with Myelodysplastic Syndromes with Excess Blasts Progressing on or After Treatment with a Hypomethylating Agent Summary of Data from the 04-24 Trial Following these results, all patients will be followed until death and/or progression, even if they have discontinued treatment for any reason. View the complete study poster HERE. Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Rigosertib, Onconova's lead candidate, is a proprietary Phase 3 small molecule agent, which we believe blocks cellular signaling by targeting RAS effector pathways.  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit http://www.onconova.com. The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease,  provides long duration of exposure, and ensures dosing under a controlled setting. The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial.  INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib.  Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy.  A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028. Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.'s future operations, clinical development of Onconova's product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova's cash and other resources to fund operating expenses and capital expenditures, Onconova's anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova's ability to continue as a going concern, the need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of Onconova's clinical trials and regulatory approval of protocols, and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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