Patient Reported Outcomes

Cheshire, United Kingdom

Patient Reported Outcomes

Cheshire, United Kingdom
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NEW YORK, May 08, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s Chief Medical Officer and Head of Business Development, Dr. Ramon Mohanlal, M.D., Ph.D., M.B.A., will present at the Evolution Summit in Miami, Chief Medical Officer Summit in Boston and Clinical Leader Forum in Philadelphia on May 8, 10 and 11, 2017, respectively. Dr. Mohanlal will discuss the “Progression of Immunotherapy and its Impact on Cancer Research” as part of his presentation at the Evolution Summit at 5:15 p.m. ET at the Ritz-Carlton Coconut Grove, as well as join a panel on “Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies” at the Chief Medical Officer Summit at 9:30 a.m. ET at the Colonnade Hotel. Finally, Dr. Mohanlal will present on the importance of “Payer Perspective, Market Access and Patient Reported Outcomes” at this year’s Clinical Leader Forum at 3:15 p.m. ET at the Hilton Philadelphia City Avenue. “It is an honor to speak at each of these prestigious conferences and present alongside some of the most exemplary leaders and pioneers in the healthcare and medical industry, opening up the dialogue around important topics that affect biopharma professionals everywhere,” said Dr. Mohanlal. “At BeyondSpring, these conversations are essential when it comes to continuing our work and growing our partnerships with other pharmaceutical professionals who have deep industry knowledge of the oncology space. Our team looks forward to capitalizing on these opportunities to help advance our lead asset, Plinabulin, which is in a Phase 3 trial as a direct anticancer agent in non-small cell lung cancer and Phase 2/3 trial for neutropenia prevention, to build toward its commercial success.” Plinabulin, a novel small molecule that alters the tumor micro-environment and stimulates dendritic cell maturation and T-cell activation, has produced encouraging data regarding the mitigation of severe neutropenia, a common and potentially life-threatening adverse effect of Docetaxel. Plinabulin can be administered one hour after chemotherapy and has the potential to be a safe, cost-effective and convenient alternative with much less bone pain than G-CSF, the current standard of care for chemotherapy-induced neutropenia. Plinabulin offers a same-day dosing advantage over G-CSF, which should be administered 24 hours after chemotherapy, per G-CSF label (next-day dosing), by which time significant damage to neutrophils has occurred. Additionally, Plinabulin has demonstrated a reduction in clinical sequelae associated with Docetaxel-induced neutropenia, including infections, sepsis, hospitalizations and the need for Docetaxel dose reductions. The Evolution Summit is a forum that brings together leading drug development executives and solution providers, with the goal of providing an intimate environment in which attendees can take part in a focused discussion on key new drivers that are shaping drug development. The Chief Medical Officer Summit is an annual gathering of physicians where they exchange best practices in the advancement of drug development within the confines of the emerging biotech space. The Clinical Leader Forum is an event that’s focused on sponsor-CRO partnerships and issues that matter most to executives at small and midsize sponsor companies. About BeyondSpring BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market. About Plinabulin Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.


NEW YORK, May 08, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s Chief Medical Officer and Head of Business Development, Dr. Ramon Mohanlal, M.D., Ph.D., M.B.A., will present at the Evolution Summit in Miami, Chief Medical Officer Summit in Boston and Clinical Leader Forum in Philadelphia on May 8, 10 and 11, 2017, respectively. Dr. Mohanlal will discuss the “Progression of Immunotherapy and its Impact on Cancer Research” as part of his presentation at the Evolution Summit at 5:15 p.m. ET at the Ritz-Carlton Coconut Grove, as well as join a panel on “Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies” at the Chief Medical Officer Summit at 9:30 a.m. ET at the Colonnade Hotel. Finally, Dr. Mohanlal will present on the importance of “Payer Perspective, Market Access and Patient Reported Outcomes” at this year’s Clinical Leader Forum at 3:15 p.m. ET at the Hilton Philadelphia City Avenue. “It is an honor to speak at each of these prestigious conferences and present alongside some of the most exemplary leaders and pioneers in the healthcare and medical industry, opening up the dialogue around important topics that affect biopharma professionals everywhere,” said Dr. Mohanlal. “At BeyondSpring, these conversations are essential when it comes to continuing our work and growing our partnerships with other pharmaceutical professionals who have deep industry knowledge of the oncology space. Our team looks forward to capitalizing on these opportunities to help advance our lead asset, Plinabulin, which is in a Phase 3 trial as a direct anticancer agent in non-small cell lung cancer and Phase 2/3 trial for neutropenia prevention, to build toward its commercial success.” Plinabulin, a novel small molecule that alters the tumor micro-environment and stimulates dendritic cell maturation and T-cell activation, has produced encouraging data regarding the mitigation of severe neutropenia, a common and potentially life-threatening adverse effect of Docetaxel. Plinabulin can be administered one hour after chemotherapy and has the potential to be a safe, cost-effective and convenient alternative with much less bone pain than G-CSF, the current standard of care for chemotherapy-induced neutropenia. Plinabulin offers a same-day dosing advantage over G-CSF, which should be administered 24 hours after chemotherapy, per G-CSF label (next-day dosing), by which time significant damage to neutrophils has occurred. Additionally, Plinabulin has demonstrated a reduction in clinical sequelae associated with Docetaxel-induced neutropenia, including infections, sepsis, hospitalizations and the need for Docetaxel dose reductions. The Evolution Summit is a forum that brings together leading drug development executives and solution providers, with the goal of providing an intimate environment in which attendees can take part in a focused discussion on key new drivers that are shaping drug development. The Chief Medical Officer Summit is an annual gathering of physicians where they exchange best practices in the advancement of drug development within the confines of the emerging biotech space. The Clinical Leader Forum is an event that’s focused on sponsor-CRO partnerships and issues that matter most to executives at small and midsize sponsor companies. About BeyondSpring BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market. About Plinabulin Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.


NEW YORK, May 08, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s Chief Medical Officer and Head of Business Development, Dr. Ramon Mohanlal, M.D., Ph.D., M.B.A., will present at the Evolution Summit in Miami, Chief Medical Officer Summit in Boston and Clinical Leader Forum in Philadelphia on May 8, 10 and 11, 2017, respectively. Dr. Mohanlal will discuss the “Progression of Immunotherapy and its Impact on Cancer Research” as part of his presentation at the Evolution Summit at 5:15 p.m. ET at the Ritz-Carlton Coconut Grove, as well as join a panel on “Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies” at the Chief Medical Officer Summit at 9:30 a.m. ET at the Colonnade Hotel. Finally, Dr. Mohanlal will present on the importance of “Payer Perspective, Market Access and Patient Reported Outcomes” at this year’s Clinical Leader Forum at 3:15 p.m. ET at the Hilton Philadelphia City Avenue. “It is an honor to speak at each of these prestigious conferences and present alongside some of the most exemplary leaders and pioneers in the healthcare and medical industry, opening up the dialogue around important topics that affect biopharma professionals everywhere,” said Dr. Mohanlal. “At BeyondSpring, these conversations are essential when it comes to continuing our work and growing our partnerships with other pharmaceutical professionals who have deep industry knowledge of the oncology space. Our team looks forward to capitalizing on these opportunities to help advance our lead asset, Plinabulin, which is in a Phase 3 trial as a direct anticancer agent in non-small cell lung cancer and Phase 2/3 trial for neutropenia prevention, to build toward its commercial success.” Plinabulin, a novel small molecule that alters the tumor micro-environment and stimulates dendritic cell maturation and T-cell activation, has produced encouraging data regarding the mitigation of severe neutropenia, a common and potentially life-threatening adverse effect of Docetaxel. Plinabulin can be administered one hour after chemotherapy and has the potential to be a safe, cost-effective and convenient alternative with much less bone pain than G-CSF, the current standard of care for chemotherapy-induced neutropenia. Plinabulin offers a same-day dosing advantage over G-CSF, which should be administered 24 hours after chemotherapy, per G-CSF label (next-day dosing), by which time significant damage to neutrophils has occurred. Additionally, Plinabulin has demonstrated a reduction in clinical sequelae associated with Docetaxel-induced neutropenia, including infections, sepsis, hospitalizations and the need for Docetaxel dose reductions. The Evolution Summit is a forum that brings together leading drug development executives and solution providers, with the goal of providing an intimate environment in which attendees can take part in a focused discussion on key new drivers that are shaping drug development. The Chief Medical Officer Summit is an annual gathering of physicians where they exchange best practices in the advancement of drug development within the confines of the emerging biotech space. The Clinical Leader Forum is an event that’s focused on sponsor-CRO partnerships and issues that matter most to executives at small and midsize sponsor companies. About BeyondSpring BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market. About Plinabulin Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.


NEW YORK, May 08, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s Chief Medical Officer and Head of Business Development, Dr. Ramon Mohanlal, M.D., Ph.D., M.B.A., will present at the Evolution Summit in Miami, Chief Medical Officer Summit in Boston and Clinical Leader Forum in Philadelphia on May 8, 10 and 11, 2017, respectively. Dr. Mohanlal will discuss the “Progression of Immunotherapy and its Impact on Cancer Research” as part of his presentation at the Evolution Summit at 5:15 p.m. ET at the Ritz-Carlton Coconut Grove, as well as join a panel on “Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies” at the Chief Medical Officer Summit at 9:30 a.m. ET at the Colonnade Hotel. Finally, Dr. Mohanlal will present on the importance of “Payer Perspective, Market Access and Patient Reported Outcomes” at this year’s Clinical Leader Forum at 3:15 p.m. ET at the Hilton Philadelphia City Avenue. “It is an honor to speak at each of these prestigious conferences and present alongside some of the most exemplary leaders and pioneers in the healthcare and medical industry, opening up the dialogue around important topics that affect biopharma professionals everywhere,” said Dr. Mohanlal. “At BeyondSpring, these conversations are essential when it comes to continuing our work and growing our partnerships with other pharmaceutical professionals who have deep industry knowledge of the oncology space. Our team looks forward to capitalizing on these opportunities to help advance our lead asset, Plinabulin, which is in a Phase 3 trial as a direct anticancer agent in non-small cell lung cancer and Phase 2/3 trial for neutropenia prevention, to build toward its commercial success.” Plinabulin, a novel small molecule that alters the tumor micro-environment and stimulates dendritic cell maturation and T-cell activation, has produced encouraging data regarding the mitigation of severe neutropenia, a common and potentially life-threatening adverse effect of Docetaxel. Plinabulin can be administered one hour after chemotherapy and has the potential to be a safe, cost-effective and convenient alternative with much less bone pain than G-CSF, the current standard of care for chemotherapy-induced neutropenia. Plinabulin offers a same-day dosing advantage over G-CSF, which should be administered 24 hours after chemotherapy, per G-CSF label (next-day dosing), by which time significant damage to neutrophils has occurred. Additionally, Plinabulin has demonstrated a reduction in clinical sequelae associated with Docetaxel-induced neutropenia, including infections, sepsis, hospitalizations and the need for Docetaxel dose reductions. The Evolution Summit is a forum that brings together leading drug development executives and solution providers, with the goal of providing an intimate environment in which attendees can take part in a focused discussion on key new drivers that are shaping drug development. The Chief Medical Officer Summit is an annual gathering of physicians where they exchange best practices in the advancement of drug development within the confines of the emerging biotech space. The Clinical Leader Forum is an event that’s focused on sponsor-CRO partnerships and issues that matter most to executives at small and midsize sponsor companies. About BeyondSpring BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market. About Plinabulin Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.


NEW YORK, May 22, 2017 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (OTCQB:TYMI), a clinical stage biotechnology company developing cancer therapeutics to address multiple tumor types, today announced that it will present data from its ongoing clinical trial with its investigational drug candidate SM-88 in prostate cancer at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 2 – 6, 2017. Details of the Company’s poster presentation are listed below: A Phase Ib/II, Open-label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of SM-88 in Patients with Prostate Cancer (J Clin Oncol 35, 2017 (suppl; abstr TPS2615)) Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics Date and Time:  Monday June 5, 2017, 8:00 AM - 11:30 AM CT Location: Hall A, Poster Board: #97b Presenter: Dr. Giuseppe Del Priore, Chief Medical Officer of Tyme Technologies, Inc. Additionally, the following abstracts have been published online in conjunction with the Meeting and are available for review via the hyperlinks below. SMK/SM-88 Toxicity, Efficacy, and Patient Reported Outcomes in Metastatic Pancreas Cancer Author(s): Steve Hoffman, Jeanetta Stega, Giuseppe Del Priore, John Rothman; Tyme Inc, New York, NY; Morehouse School of Medicine, Atlanta, GA. J Clin Oncol 35, 2017 (suppl; abstr e14060). SM-88/SMK Non-hormonal Therapy in Recurrent or Untreated Prostate Cancer Author(s): Steve Hoffman, John Rothman, Giuseppe Del Priore, Jeanetta Stega; Tyme Inc, New York, NY; Morehouse School of Medicine, Atlanta, GA. J Clin Oncol 35, 2017 (suppl; abstr e16540). SM-88 in Non-metastatic Rising PSA-recurrent Prostate Cancer Author(s): Giuseppe Del Priore, Gerald H. Sokol, Wen-Tien Chen, Che-Kai Tsao, Steve Hoffman; Morehouse School of Medicine, Atlanta, GA; Florida Cancer Institute New Hope, Hudson, FL; Stony Brook University, Stony Brook, NY; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY; Tyme Inc, New York, NY. J Clin Oncol 35, 2017 (suppl; abstr e16567). Phase Ib Pharmacokinetics of Non-hormonal SM-88 in Patients with Non-metastatic Recurrent Prostate Cancer Author(s): Giuseppe Del Priore, John Rothman, Gerald H. Sokol, Karen Hoffman, Avi S. Retter, Steve Hoffman; Morehouse School of Medicine, Atlanta, GA; Tyme Inc, New York, NY; Florida Cancer Institute New Hope, Hudson, FL; Eastchester Center for Cancer Care, Bronx, NY; Montefiore Medical Center, Bronx, NY. J Clin Oncol 35, 2017 (suppl; abstr e14061). About Tyme Tyme Technologies is a clinical-stage biopharmaceutical company focused on development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications. Its lead investigational candidate, SM-88, is a novel first-in-class therapy that is designed to use cancer’s unusual metabolism to selectively break down the cellular defenses of tumors, leading to tumor cell death. Through clinical trials and expanded access programs, SM-88 has been used in over 84 individuals and shown a clinical response in thirteen cancer types. In its first-in-human trial for end-stage, metastatic cancer patients, SM-88 treatment resulted in a median overall survival of 26 months, with 32% of patients alive at the end of the three-year evaluation period without any drug-related serious adverse events. The Company is currently conducting a Phase II trial in prostate cancer in addition to ongoing collaborations with the Mayo Clinic, Mount Sinai and other institutions. For more information, visit our website: www.tymeinc.com. Forward-Looking Statements/Disclosure Notice In addition to historical information, this press release contains forward-looking statements that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates (including SM-88), our drug development plans and strategies, our completed and planned clinical trials and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Tyme’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of Tyme’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 30, 2016 (available at www.sec.gov). The information contained in this press release is as of May 22, 2017 and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.


NEW YORK, May 22, 2017 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (OTCQB:TYMI), a clinical stage biotechnology company developing cancer therapeutics to address multiple tumor types, today announced that it will present data from its ongoing clinical trial with its investigational drug candidate SM-88 in prostate cancer at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 2 – 6, 2017. Details of the Company’s poster presentation are listed below: A Phase Ib/II, Open-label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of SM-88 in Patients with Prostate Cancer (J Clin Oncol 35, 2017 (suppl; abstr TPS2615)) Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics Date and Time:  Monday June 5, 2017, 8:00 AM - 11:30 AM CT Location: Hall A, Poster Board: #97b Presenter: Dr. Giuseppe Del Priore, Chief Medical Officer of Tyme Technologies, Inc. Additionally, the following abstracts have been published online in conjunction with the Meeting and are available for review via the hyperlinks below. SMK/SM-88 Toxicity, Efficacy, and Patient Reported Outcomes in Metastatic Pancreas Cancer Author(s): Steve Hoffman, Jeanetta Stega, Giuseppe Del Priore, John Rothman; Tyme Inc, New York, NY; Morehouse School of Medicine, Atlanta, GA. J Clin Oncol 35, 2017 (suppl; abstr e14060). SM-88/SMK Non-hormonal Therapy in Recurrent or Untreated Prostate Cancer Author(s): Steve Hoffman, John Rothman, Giuseppe Del Priore, Jeanetta Stega; Tyme Inc, New York, NY; Morehouse School of Medicine, Atlanta, GA. J Clin Oncol 35, 2017 (suppl; abstr e16540). SM-88 in Non-metastatic Rising PSA-recurrent Prostate Cancer Author(s): Giuseppe Del Priore, Gerald H. Sokol, Wen-Tien Chen, Che-Kai Tsao, Steve Hoffman; Morehouse School of Medicine, Atlanta, GA; Florida Cancer Institute New Hope, Hudson, FL; Stony Brook University, Stony Brook, NY; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY; Tyme Inc, New York, NY. J Clin Oncol 35, 2017 (suppl; abstr e16567). Phase Ib Pharmacokinetics of Non-hormonal SM-88 in Patients with Non-metastatic Recurrent Prostate Cancer Author(s): Giuseppe Del Priore, John Rothman, Gerald H. Sokol, Karen Hoffman, Avi S. Retter, Steve Hoffman; Morehouse School of Medicine, Atlanta, GA; Tyme Inc, New York, NY; Florida Cancer Institute New Hope, Hudson, FL; Eastchester Center for Cancer Care, Bronx, NY; Montefiore Medical Center, Bronx, NY. J Clin Oncol 35, 2017 (suppl; abstr e14061). About Tyme Tyme Technologies is a clinical-stage biopharmaceutical company focused on development and commercialization of highly targeted cancer therapeutics with a broad range of oncology indications. Its lead investigational candidate, SM-88, is a novel first-in-class therapy that is designed to use cancer’s unusual metabolism to selectively break down the cellular defenses of tumors, leading to tumor cell death. Through clinical trials and expanded access programs, SM-88 has been used in over 84 individuals and shown a clinical response in thirteen cancer types. In its first-in-human trial for end-stage, metastatic cancer patients, SM-88 treatment resulted in a median overall survival of 26 months, with 32% of patients alive at the end of the three-year evaluation period without any drug-related serious adverse events. The Company is currently conducting a Phase II trial in prostate cancer in addition to ongoing collaborations with the Mayo Clinic, Mount Sinai and other institutions. For more information, visit our website: www.tymeinc.com. Forward-Looking Statements/Disclosure Notice In addition to historical information, this press release contains forward-looking statements that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates (including SM-88), our drug development plans and strategies, our completed and planned clinical trials and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Tyme’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of Tyme’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 30, 2016 (available at www.sec.gov). The information contained in this press release is as of May 22, 2017 and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Electronic Clinical Outcome Assessment (eCOA) Solutions Market, 2014-2025" report to their offering. The global electronic clinical outcome assessment (eCOA) solutions market is expected to reach USD 2.16 billion by 2025. The complexity in healthcare information management is anticipated to fuel the demand for eCOA solutions in coming years. These solutions deliver accurate and timely health information and reduce burden of patients enrolled in clinical trials. eCOA measures overall mental state, patient symptoms, and the progression of a disease. Electronic diaries and electronic Patient Reported Outcomes (ePRO) are a part of eCOA platforms. Electronic diaries help document patient response. These are used as support systems for ePRO. In all the applications of clinical outcome assessment systems, the compliance rates are more than 90%, which helps accelerate research procedures. In addition, assessment systems help detect probable adverse conditions in advance for patients, which is crucial for taking preventive measures to avoid adverse effects in future. The ePRO platforms transfer real-time data from the patients to healthcare professionals for accurate decision-making and better evaluation of a patient's health. Thus, the adoption of these platforms is expected to grow in near future. For more information about this report visit http://www.researchandmarkets.com/research/rntlbk/electronic


News Article | May 22, 2017
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BOSTON--(BUSINESS WIRE)--Analysis Group, one of the largest private economics consulting firms, announces the promotion of 41 consultants and welcomes seven new affiliates to the firm. “ We are pleased to recognize the outstanding efforts of our consultants, as well as the addition of such impressive new affiliates, all of whom are recognized leaders in their respective fields,” said CEO and Chairman Martha S. Samuelson. Shannon W. Anderson, a professor of management at the UC Davis Graduate School of Management, conducts research on the design of cost accounting systems and on how firms use management control practices to mitigate risk and facilitate collaboration in inter-firm transactions. This research includes performance measurement, incentive contracting, supply chain contracting, and operations management. Professor Anderson uses empirical analysis of firm-level accounting and operational data to test economic theories about firm performance. She also has experience designing and administering surveys and analyzing survey data. Her published work has employed data from many industries, including automotive, electronics manufacturing, office furniture manufacturing, commercial airlines, consumer retail, coal extraction, transportation, and warehousing and distribution. Professor Anderson coauthored the award-winning book Implementing Management Innovations and the textbook Fundamentals of Cost Accounting (now in its 5th edition). Her research has been published in leading research journals, including The Accounting Review, Management Science, and Contemporary Accounting Research, and has been funded by the American Institute of Certified Public Accountants, the Institute of Internal Auditors, and the National Science Foundation, among others. Jacques Crémer, research faculty at the Toulouse School of Economics, is an expert in industrial organization with a focus on competition, contracting, auction and planning theory, and the economics of organization. His recent research examines these issues with applications to the economics of two-sided platforms, industries with network effects, and the Internet. Professor Crémer has testified before the European Commission in relation to the AOL-Time Warner merger, and consulted to clients including Microsoft, Google, Sucre Saint Louis, Intel, GTE, and Time Warner. He has published on such topics as the consequences of mergers on competition and policy, the costs and benefits of vertical integration, and the value of switching costs. Professor Crémer’s work has appeared in peer-reviewed journals such as American Economic Review and The Quarterly Journal of Economics. He is a Fellow of the European Economic Association and the Econometric Society. From 2011 to 2014, Professor Crémer was the Scientific Director at the Toulouse School of Economics (TSE), and was previously Director of Institut d’Economie Industrielle (IDEI), a TSE research institute focused on partnerships with government and industry. Randal S. Milch, a Distinguished Fellow at the New York University School of Law's Center on Law and Security, has extensive expertise in corporate governance, cybersecurity, and data privacy issues. Over his 21 years at Verizon Communications Inc. (where he was EVP and General Counsel to the Chair and CEO), Mr. Milch was deeply involved in the deregulation and transformation of the telecommunications industry. He oversaw the public policy, legal, regulatory, government affairs, and security groups at Verizon, testified before committees of Congress, and organized and led significant public policy campaigns relating to state and federal legislation and transactional approvals. He also managed national security matters, set cyber-policy, and served as the senior cleared executive. Mr. Milch is currently chair of the Board of Equal Justice Works and serves as a trustee of New York University School of Law. He is a former partner in the Washington, D.C. office of Donovan, Leisure, Newton & Irvine. Michael D. Mitzenmacher, the Thomas J. Watson, Sr. Professor of Computer Science at Harvard University’s John A. Paulson School of Engineering and Applied Sciences, researches the design and analysis of algorithms, networks and data transmission, computer security, information theory, and use of encryption. He has consulted to numerous technology companies and research laboratories, including Adverplex (Cogolabs), Akamai, AT&T, Digital Fountain, eHarmony, Fluent Mobile (Fiksu), Google, Huawei, ITA Software, JobSync, Microsoft, Mitsubishi Research Laboratories, and Yahoo. In addition, he has served as an expert witness on software and intellectual property issues in several cases, including testimony in multiple trials. Professor Mitzenmacher has authored or coauthored over 200 conference and journal publications on various topics, including algorithms for the Internet; efficient hash-based data structures; erasure; and error-correcting codes, power laws, and compression. His work on low-density parity-check codes shared the 2002 IEEE Information Theory Society Best Paper Award and won the 2009 ACM SIGCOMM Test of Time Award. Prior to joining Harvard, he worked as a research scientist at Digital Systems Research Center on information retrieval on the Web, erasure codes, error-correcting codes, on-line algorithms, and load balancing. Nathan Novemsky, a professor of marketing in the Yale School of Management and a professor of psychology at Yale University, is an expert in the psychology of judgment and decision-making, an area that overlaps heavily with behavioral economics and consumer behavior. His area of specialization is examining how consumers are affected by information in their environments, including how particular types of information impact their choices and judgments. He is a member of the Yale Center for Customer Insights, and has consulted on numerous legal cases (e.g., deceptive advertising, defamation) related to how individuals interpret information they see in the media and other contexts. Professor Novemsky has published widely on the topics of judgment and decision-making, and regularly teaches these concepts to executives around the world. Paul Oyer, the Fred H. Merrill Professor of Economics at the Stanford Graduate School of Business, is an expert in the economics of organizations and human resource practices. In the field of personnel economics, he has undertaken several studies on how organizations pay and provide incentives for their workers. He has also examined how salespeople and executives react to incentive systems, and why some firms use broad-based stock option programs. In addition, he has conducted research on how firms have adjusted their human resource practices in response to legal barriers for dismissing workers. His current research focuses on how companies identify and recruit workers in highly-skilled and competitive labor markets. His research has been published in numerous peer-reviewed journals, including The Quarterly Journal of Economics, American Economic Review, and The Journal of Finance. Professor Oyer is a research associate with the National Bureau of Economic Research and the editor-in-chief of the Journal of Labor Economics. Prior to joining Stanford, he was on the faculty of the Kellogg School of Management at Northwestern University. He also previously worked for Booz, Allen & Hamilton; 3Com Corporation; and ASK Computer Systems. John E. Ware, the Professor and Chief of Outcomes Measurement Science in the Department of Quantitative Health Sciences at the University of Massachusetts Medical School, is an internationally recognized leader in measuring Patient Reported Outcomes (PRO). His substantial contributions to the outcomes research field have focused on developing, standardizing, and applying health metrics to assess patient reported outcomes. His work has led to the development of a set of standardized, generic PRO measures, including the SF-36® Health Survey, as well as disease-specific measures such as the Headache Impact Test (HIT-6™) survey. Professor Ware frequently provides guidance on evidence support for PRO labeling, and he has been the invited expert for testimony on PRO topics at hearings held by the U.S. Food and Drug Administration. His current research interests also include applying modern psychometric methods to construct more actionable measures, including the first disease-specific quality-of-life (QOL) impact scale standardized across conditions and normed in representative chronically-ill populations. Professor Ware is a member of the National Academy of Medicine (formerly the Institute of Medicine). The firm promoted one consultant to managing principal. Richard A. Mortimer specializes in health economics, industrial organization, microeconomic theory, and econometrics. He has provided economic analyses in numerous antitrust matters involving questions of market power, pricing, and market exclusion and foreclosure in a variety of industries, with a focus on healthcare. He has also provided analyses and expert testimony on behalf of clients in the healthcare industry on litigation and government investigations involving allegations of improper promotion and kickback payments. Dr. Mortimer's experience includes leading analyses of large data sets to assess questions of market definition, class certification, liability, and damages. In addition to work in litigation, Dr. Mortimer has undertaken research in the area of health care policy, and he has authored several public policy studies related to pharmaceutical and general health care legislation. His research has been published in leading peer-reviewed journals, including Health Affairs, Nature Reviews Drug Discovery, The Journal of Industrial Economics, and Journal of Medical Economics. In Boston, Ryan Booth specializes in applying microeconomic theory, antitrust economics, and econometric methods to a range of issues that include assessing the competitive effects of firm conduct, the implications of mergers and acquisitions on consumer welfare, and the effects of government policy on consumer and firm behavior. Emily Cotton has extensive experience conducting complex quantitative and qualitative analyses of data in both mergers and litigation matters, including antitrust, bankruptcy, class certification, intellectual property, securities, survey design, tax, and transfer-pricing matters. Chris Feige specializes in the areas of finance, securities, and financial systems. He has developed complex valuation models, including discounted cash flow models, and has analyzed asset-backed securities and credit ratings in support of expert testimony in a number of bankruptcy and damages matters. Lauren Hunt specializes in providing analyses in finance cases involving complex securities, including mortgage-backed securities (MBS). She has supported experts in numerous litigations involving class action claims, allegations of violations of Sections 10b-5 and 11, and damages claims relating to the underwriting of mortgage loans. Kenneth Weinstein specializes in the application of quantitative methods to real-world problems involving decision-making, strategy, risk management, and litigation. He has managed the analysis of large transaction-level and claims databases, helped clients mitigate the risks associated with distributing controlled substances, and developed flexible damages models for negotiating high-stakes settlements. Hongbo Yang, a specialist in health economics and outcomes research, has directed and conducted numerous studies in a variety of therapeutic areas, including autoimmune diseases, infectious diseases, diabetes, blood disorders, oncology, women's health, and central nervous system diseases. She has led the submission of economic models to multiple health technology assessment agencies (HTAs), including NICE, CADTH, INESSS, and OHTAC. In Denver, Carletta Wong has a decade of experience applying economic consulting expertise to a variety of litigation matters involving securities, accounting, antitrust, corporate governance, off-label pharmaceutical marketing, and intellectual property and trade secrets. In Los Angeles, Keith Betts specializes in the application of advanced biostatistics techniques in the field of health economics and outcomes research. He has broad experience developing research strategies in a range of disease areas, including immunology, hematology, oncology, psychiatry, and virology. In Menlo Park, Anjali D. Oza specializes in the application of economic, statistical, and market research methods to litigation and strategy matters. She is an expert in designing and evaluating qualitative and quantitative surveys, including conjoint analysis and experiments. In Montréal, François Laliberté applies his distinctive competencies in biostatistics and economics to the field of health outcomes research. He has investigated different facets of health research including safety, cost of illness, resource utilization, adherence to therapies, cost-effectiveness, and treatment outcomes. Markus von Wartburg specializes in the application of econometric methods and microeconomic theory to complex problems in antitrust and competition, commercial litigation, media and telecommunications, finance, and intellectual property. In New York City, Duncan Fung specializes in commercial litigation matters involving securities, finance, valuation, corporate governance, and statistics. He has supported clients on consulting engagements involving structured finance products, hedge funds, market microstructure, employee stock options, equity financing trades, and liquidity in money markets. Stephanie Lee’s litigation and advisory experience includes analyses of municipal bonds and interest rate swaps, auction-rate securities, student loan asset-backed securities, residential mortgage-backed securities, hedge funds, and mutual funds. She has provided testimony to Financial Industry Regulatory Authority (FINRA) arbitration panels. In Washington, D.C., F. Michael Nolan has extensive experience applying microeconomic, financial, and accounting principles to complex business litigation matters involving automobiles, agricultural products, high-technology products, telecommunications, consumer electronics, medical equipment, and pharmaceuticals. Federico Temerlin specializes in the application of economics, finance, and statistical theory to the analysis of complex legal and business disputes. He has evaluated issues related to misrepresentation of information, damages modeling, business and asset valuation, complex financial structures, tax shelters, and corporate restructurings. The firm promoted 25 consultants to manager or senior economist. In Beijing: Simeng Han. In Boston: Anya Blank, Konstantin A. Danilov, Katie Franklin, Olga Korolev, Elizabeth Milsark, Jeremy Smith, Yan Song, Todor Stoyanov, David Toniatti, and Kristof Zetenyi. In Chicago: Mark Berberian and David Smith. In Dallas: Jeffrey Hulbert. In Denver: Stacey Chan. In Los Angeles: Maral DerSarkissian, Anne LaRue, Jinlin Song, Nathan Trujillo, and Joel Wiles. In Menlo Park: Daniel Deisenroth and Ruoding Tan. In Montréal: Dominic Pilon. In San Francisco: Tracy Danner. In Washington, D.C.: Anna Gumen. Analysis Group is one of the largest private economics consulting firms, with more than 700 professionals across 11 offices in the United States, Canada, and China. Since 1981, we have provided expertise in economics, finance, health care analytics, and strategy to top law firms, Fortune 500 companies, and government agencies worldwide. Our internal experts, together with our network of affiliated experts from academia, industry, and government, offer our clients exceptional depth of expertise.

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