RESEARCH TRIANGLE PARK, NC – JANUARY 27, 2015 – Envisia Therapeutics today announced that it has initiated a phase 2a clinical trial to investigate the safety and tolerability of its lead product, ENV515, in patients with glaucoma. ENV515is a proprietary, fully biodegradable PRINT® (Particle Replication In Non-Wetting Templates) particleformulation of a prostaglandin analog, travoprost, with the potential forsustained intraocular pressure (IOP) reduction over as many as six months. ENV515 offersthe potential to significantly address the poor compliance that exists among glaucoma patients today to limit disease progression and vision loss.
Envisia Therapeutics Initiates Phase 2a Clinical Trial for ENV515 in Patients with Glaucoma
Athersys and Cell Therapy Catapult Announce Grant to Support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory Condition
Innovate UK Grant Awarded for MultiStem(R) Therapy Clinical Trial in United Kingdom
LONDON and CLEVELAND, Jan. 22, 2015 (GLOBE NEWSWIRE) -- Athersys Limited (an affiliate of Athersys, Inc.) (Nasdaq:ATHX) and the Cell Therapy Catapult, a not-for-profit centre, which is focused on the development of the United Kingdom cell therapy industry to increase the nation's health and wealth, are pleased to announce that Athersys Limited has been awarded a grant from Innovate UK, formerly the Technology Strategy Board, which will support a Phase 2a clinical study evaluating the administration of MultiStem® cell therapy to acute respiratory distress syndrome (ARDS) patients.
CoLucid Pharmaceuticals, Inc., Raises $37.1 Million in Series C Preferred Stock Offering
Durham, NC, January 13, 2015/PRNewswire/ -- CoLucid Pharmaceuticals, Inc., today announced that it has completed a $37.1 million Series C preferred stock offering. The financing was led by TVM Capital Life Science, based in Montreal and Munich,and included participation from new investors Novo Ventures and Auriga Partners. All of the Company’s existing investors also participated in the Series C, including Pappas Ventures, Domain Associates, Care Capital, Triathlon Medical Ventures and Pearl Street Ventures. Joining the board of directors will be Dr. Luc Marengere from TVM Capital Life Science and Dr. Martin Edwards from Novo Ventures.
Chimerix Receives Notice of Allowance for Brincidofovir Composition of Matter Patent Extending Exclusivity to 2034
Opportunity to pursue multiple additional indications for brincidofovir
DURHAM, N.C., Jan. 12, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent application covering a method of synthesis and the commercial morphic form of brincidofovir. With the addition of this most recent patent, composition of matter coverage for brincidofovir in the U.S. is expected to extend to October 2034.
M. Michelle Berrey, M.D. M.P.H., President and CEO, said, "This important allowance significantly increases the patent protection of brincidofovir for our lead indications to prevent clinically significant cytomegalovirus infection in hematopoietic cell transplant recipients and for the treatment of adenovirus infection. Importantly, this will provide 20 years of patent coverage for Chimerix to pursue multiple additional indications in broad patient populations."
Milestone Pharmaceuticals Receives FDA Clearance of MSP-2017 Phase 2 IND
MONTREAL, Jan. 12, 2015 /PRNewswire/ - Milestone Pharmaceuticals, Inc. announced today that it received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 study of MSP-2017 for the treatment of acute episodes of Paroxysmal Supraventricular Tachycardia (PSVT). The trial is expected to begin patient enrollment in early 2015.
Ultragenyx Announces License of Intellectual Property Related to the Treatment of Huntington's Disease With Triheptanoin
NOVATO, Calif., Jan. 7, 2015 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced a license agreement with Inserm Transfert SA and Institut du Cerveau et de la Moelle Epiniere (ICM) for intellectual property related to the treatment of Huntington's disease with triheptanoin (UX007).
"Huntington's is a severe and lethal rare genetic disease," commented Emil D. Kakkis, Ph.D., M.D., Chief Executive Officer and President of Ultragenyx. "Energy deficiency is believed to play a role in the pathophysiology of Huntington's disease, and we are encouraged by data from a small pilot study suggesting improvement in brain energy metabolism after treatment with triheptanoin."
Mirati Therapeutics Doses First Patient in Phase 2 Study of Mocetinostat in Bladder Cancer Patients with Genetic Alterations of CREBBP and EP300
SAN DIEGO, Jan. 7, 2015 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that the first patient has been dosed in a Phase 2 clinical trial designed to evaluate the efficacy, safety and pharmacokinetics of mocetinostat as a treatment for a select group of patients with bladder cancer. The trial will enroll patients whose tumors have mutations or deletions of the CREBBP and/or EP300 genes.
Kyowa Hakko Kirin and Syndax Announce an Exclusive License Agreement to Develop and Commercialize Entinostat in Japan and Korea
Tokyo, Japan, January 8, 2015 and Waltham, Mass., January 7, 2015 --- Kyowa Hakko Kirin Co., Ltd., (Headquarters: Chiyoda-ku, Tokyo; president and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") and Syndax Pharmaceuticals, Inc., (Waltham, Mass.; president and CEO: Arlene M. Morris, “Syndax”) today jointly announced that the companies have entered into a license agreement for the exclusive rights to develop and commercialize entinostat in Japan and Korea. Entinostat is a Class I selective histone deacetylase (HDAC) inhibitor being developed by Syndax in the United States and Europe in combination with hormone therapy for advanced breast cancer and immune therapy combinations in solid tumors.
Mirati Therapeutics Doses First Patient in Investigator-Sponsored Phase 2 Study of Mocetinostat in Non-Hodgkin's Lymphoma
Study to focus on mutations and deletions of CREBBP and EP300 genes in lymphomas
SAN DIEGO, Jan. 6, 2015 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that Memorial Sloan Kettering Cancer Center in New York has dosed the first patient in an investigator-sponsored Phase 2 clinical trial of mocetinostat in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). The trial will enroll patients whose tumors have mutations or deletions of the CREBBP and/or EP300 genes.
Ultragenyx Initiates New Development Program Studying KRN23 for the Treatment of Tumor-Induced Osteomalacia
NOVATO, Calif., Jan. 6, 2015 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced the initiation of a new development program for the human monoclonal anti-FGF23 antibody KRN23 (UX023) in tumor-induced osteomalacia (TIO). TIO results from typically benign tumors that produce excess levels of fibroblast growth factor 23 (FGF23), which can lead to severe osteomalacia, fractures, bone and muscle pain, and muscle weakness. Ultragenyx intends to initiate a Phase 2 study of KRN23 in six adult TIO patients in the first half of 2015.
KRN23 is being developed under a license and collaboration agreement between Ultragenyx and Kyowa Hakko Kirin Co., Ltd. KRN23 is being evaluated in a separate Phase 2 clinical study for pediatric patients with X-linked hypophosphatemia (XLH) and has completed multiple Phase 1/2 studies in adults with XLH.
