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.
Mirati Therapeutics Doses First Patient in Phase 2 Study of Mocetinostat in Bladder Cancer Patients with Genetic Alterations of CREBBP and EP300
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.
New Clinical Trial Will Evaluate Antibacterial Envelope in Cardiac Implantable Electronic Device Patients at Risk for Major Infections
Medtronic Announces First Patient Enrollment in the WRAP Infection Clinical Trial
MINNEAPOLIS – Jan. 7, 2015 – Medtronic, Inc. (NYSE: MDT) today announced the first patient enrollment in the WRAP Infection Clinical Trial, which will evaluate the effectiveness of the TYRX™ Absorbable Antibacterial Envelope in reducing major infections in patients with cardiac implantable electronic devices (CIEDs) at risk for infection. The global clinical trial also will assess healthcare costs related to treatment of major infections in CIED patients. The first patient implant was performed by Edward J. Schloss, M.D., director of electrophysiology at The Christ Hospital in Cincinnati.
Athersys Finishes Enrollment of Phase 2 Study of MultiStem(R) Cell Therapy for Ischemic Stroke Top-Line Data Readout Expected Around the End of the First Quarter, 2015
Top-Line Data Readout Expected Around the End of the First Quarter, 2015
CLEVELAND, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys' MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015.
Mirati Therapeutics Doses First Patient in Expansion Cohorts of Phase 1b Trial of MGCD265 in Genetically Selected Patients
Study Seeks to Confirm a High Response Rate among Cancer Patients with MET and Axl Genetic Alterations
SAN DIEGO, Dec. 23, 2014 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that the first patient with Non-Small Cell Lung Cancer (NSCLC) has been dosed in a Phase 1b clinical trial of MGCD265 in selected patients exhibiting genetic alterations of MET or Axl. In this segment of the study, one of the expansion cohorts will enroll patients with NSCLC and another will enroll patients with other solid tumors. Both cohorts will enroll only those patients that have specific MET driver mutations including MET gene point mutations, gene amplification, and MET or Axl gene rearrangements.
CardioDx Raises $35 Million in Equity Financing
- Funding Slated for Further Commercial Deployment of the Corus® CAD Blood Test and Continued Development of Next Generation Products -
REDWOOD CITY, CA – December 18, 2014 - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the close of $35 million in total equity financing. Alberta Investment Management Corporation (AIMCo) participated in this round together with the company's existing investors.
Chimerix and ContraVir Pharmaceuticals Establish Strategic Collaboration for Antiviral Drug Candidate CMX157
DURHAM, N.C. and EDISON, N.J., Dec. 18, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX) a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, and ContraVir Pharmaceuticals, Inc. (OTCBB:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the companies have entered into a strategic collaboration for the further clinical development and commercialization of CMX157. CMX157 is a highly potent analog of the successful antiviral drug tenofovir DF (Viread®).
Under the agreement, ContraVir licenses CMX157 from Chimerix in exchange for an upfront payment consisting of 120,000 shares of ContraVir preferred stock with a stated value of $1.2 million. In addition, Chimerix is eligible to receive up to approximately $20 million in clinical, regulatory and initial commercial milestones in the United States and Europe, as well as royalties and additional milestones based on commercial sales in those territories.
Ultragenyx Announces Initiation of Phase 3 Study of Recombinant Human Beta-Glucuronidase in Mucopolysaccharidosis Type 7
Agreement Reached With Both FDA and EMA on Pivotal Trial Design
NOVATO, Calif., Dec. 15, 2014 (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 the dosing of the first patient in the pivotal Phase 3 study of recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of Mucopolysaccharidosis 7 (MPS 7, Sly syndrome).
"We are pleased to have reached alignment with both the FDA and EMA on our single pivotal study design for this devastating disease," commented Sunil Agarwal, M.D., Chief Medical Officer of Ultragenyx. "This is an important step forward for these patients who have no approved treatment options. It is also an important milestone for Ultragenyx as it is the start of our first Phase 3 program."
The Phase 3 global, randomized, placebo-controlled, blind-start clinical study will assess the efficacy and safety of rhGUS in 12 patients between 5 and 35 years of age. Patients will be randomized to one of four groups. One cohort begins rhGUS therapy immediately, while the other three start on placebo and cross over to rhGUS at different predefined time points in a blinded manner. This novel trial design generates treatment data from all 12 patients, improving the statistical power of the study relative to a traditional parallel-group design. Based on data from the Phase 1/2 study, patients will be dosed with 4 mg/kg of rhGUS every other week for up to a total of 48 weeks, and all groups will receive a minimum of 24 weeks of treatment with rhGUS.
