CAMBRIDGE, Mass., Mar. 1, 2016 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine, has announced that it has received a Special Protocol Agreement for its second pivotal Phase 3 clinical trial, called SPARTAN, from the U.S. Food and Drug Administration (“FDA”). The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 130 sites in the U.S., United Kingdom and Germany. CoLucid expects migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”).
CoLucid Pharmaceuticals Announces Special Protocol Agreement for SPARTAN
Thrasos Announces Promising Results for Phase 2 THR-184 Dose Ranging Clinical Study for the Prevention of Acute Kidney Injury (AKI)
MONTREAL Canada & Boston MA, February 29, 2016 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today announced it has successfully completed its Phase 2, first-in-patients, dose ranging, clinical study of THR-184 for the prevention of acute kidney injury (AKI) in at risk patients undergoing cardiac surgery (NCT01830920). In the study, there was a reduction in the incidence of AKI in patients treated with the highest dose and THR-184 was safe and well tolerated. The effect was observed across different definitions of AKI and was most prominent in patients with underlying chronic kidney disease (CKD), which is an important risk factor for AKI.
CoLucid Pharmaceuticals Announces Confirmatory Support for Non-vasoconstrictive Mechanism of Action for Lasmiditan
CAMBRIDGE, Mass., Feb. 23, 2016 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the completion of a preclinical in vivo study examining the effect of lasmiditan on coronary and carotid artery diameters. This study confirms the lack of effect of lasmiditan on coronary artery and carotid artery vasoconstriction; the data are expected to be used in support of potential future regulatory filings.
One-Year Results From Phase 2 Stroke Study of MultiStem® Cell Therapy Demonstrate a Significantly Higher Rate of Complete or Nearly Full Recovery
CLEVELAND February 17, 2016 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced positive results from the analysis of one-year follow-up data from its Phase 2 clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who have suffered an ischemic stroke. Dr. David Hess, lead clinical investigator of this study and a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia, Augusta University, presented the summary results today at the 2016 International Stroke Conference in Los Angeles. The one-year data demonstrates that MultiStem-treated subjects on average continued to improve through one year and had a significantly higher rate of "Excellent Outcome" (defined clinically as attaining mRS 0-1, NIHSS 0-1 and BI ≥95) compared to placebo subjects at one year when evaluating all subjects enrolled in the study (p=0.02), i.e., the intent-to-treat population. The relative improvement in Excellent Outcomes was even more pronounced in the patients who received MultiStem treatment within 36 hours of the stroke (p < 0.01).
Envisia Therapeutics Announces First Patient Dosed in Second Cohort of Novel Phase 2 Program Evaluating ENV515 in Patients with Glaucoma
RESEARCH TRIANGLE PARK, NC – January 12, 2015 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today announced it has dosed its first patient in the second cohort of the phase 2 clinical program evaluating the Company's lead product candidate, ENV515. ENV515 is an extended-release formulation of travoprost that could offer sustained reduction in intraocular pressure (IOP) for more than six months after a single dose.
Healios and Athersys Enter Into Regenerative Medicine Partnership for Treatment of Stroke Using MultiStem(R) Therapy
CLEVELAND and TOKYO, Jan. 08, 2016 – Healios K.K. ("Healios") (Tokyo Stock Exchange:4593) and Athersys, Inc. ("Athersys") (NASDAQ:ATHX) have announced a partnership and license agreement that will focus on the development and commercialization of novel cell therapy treatments, including MultiStem® for the treatment of ischemic stroke and potentially other indications, in Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf stem cell therapy being developed by Athersys, with an initial focus on treating ischemic stroke.
Afferent Pharmaceuticals named one of "The Hottest Startups of 2015" by Forbes
Afferent Pharmaceuticals named one of "The Hottest Startups of 2015" by Forbes.
Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Announce Collaboration to Evaluate Combination of Avelumab and Entinostat in Ovarian Cancer
Darmstadt, Germany, New York, US and Waltham, Mass., US, January 4, 2016 – Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals, Inc. announced today that they have entered into a collaboration agreement to evaluate avelumab*, an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral, small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory Tcells), in patients with heavily pre-treated, recurrent ovarian cancer. Avelumab is currently under clinical investigation across a broad range of tumor types by the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer. This is an exclusive agreement between the alliance and Syndax to study the combination of these two investigational agents in ovarian cancer. Syndax will be responsible for conducting the Phase Ib/II clinical trial in ovarian cancer.
Afferent Pharmaceuticals Advances Novel Molecule, AF-130, to Phase 1 Clinical Trial
San Mateo, CA – December 8, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, announced today initiation of the company’s Phase 1 trial of AF-130, a selective and differentiated P2X3 antagonist. Afferent’s Phase 1, double-blind, randomized, placebo-controlled trial is designed to assess the safety, tolerability and pharmacokinetics of single ascending doses and, in a second cohort, multiple ascending doses of AF-130 administered to healthy subjects. Further information regarding the study can be found at https://clinicaltrials.gov/.
Syndax Announces Initiation Of Entinostat Clinical Program In Japan By Partner Kyowa Hakko Kirin
WALTHAM, Mass., December 1, 2015 – -- Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing entinostat as a combination therapy in multiple cancer indications, announced today the initiation of the entinostat clinical program in Japan by its partner Kyowa Hakko Kirin, Co., Ltd. Entinostat, an oral, small molecule drug candidate that targets both cancer cells and immune regulatory cells, is being developed by Syndax as an immuno-oncology therapeutic and evaluated as a treatment for advanced hormone receptor positive (HR+) breast cancer in an ongoing Phase 3 clinical trial (designated E2112) in the United States. In September 2013, entinostat was granted breakthrough therapy designation by the U.S. Food and Drug Administration in advanced HR+ breast cancer following positive results from the Phase 2b clinical trial, ENCORE-301.
