GTXI Capesaris placed on clinical hold. RGEN PDUFA date. TRGT added to database + CHTP THLD ANTH GENT news
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) briefing materials are now available HERE. The meeting will be held on Thursday, February 23, 2012 to review NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension.
GTx, Inc. (Nasdaq: GTXI) announced that its clinical trials evaluating Capesaris (GTx-758) for primary (first line) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal treatment, have been placed on clinical hold by the FDA. This affects its Phase 2 loading dose finding clinical trial and its Phase 2b maintenance dose finding clinical trial, as well as its Phase 2 clinical trial in men with castration resistant prostate cancer. This follows reports of an increased risk of venous thromboembolic events, or blood clots, in subjects treated with Capesaris at the doses studied (1000 mg and higher). In a separate news release today it maintained previous guidance that Phase 3 data of Enobosarm (OstarineTM, GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC) is due 1Q 2013.
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) released data from its Phase 2b trial of TH-302 in combination with gemcitabine compared to gemcitabine alone in patients with first-line advanced pancreatic cancer. The primary endpoint was met, with progression free survival of 5.6 months compared with 3.6 months for patients treated with gemcitabine alone, with a hazard ratio of 0.61 (p = 0.005). Further detailed data will be presented at a future major medical conference.
Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) gave a pipeline update today noting that the Data Safety Monitoring Board (DSMB) will meet in second week of March 2012 to review safety data and conduct an interim efficacy analysis of its VISTA-16 Phase 3 pivotal trial of varespladib treatment in Acute Coronary Syndromes (ACS) patients. Interim efficacy analysis will also be conducted in the first week of March in its Phase 2b PEARL-SC of blisibimod in patients with lupus.
Gentium S.p.A. (Nasdaq:GENT) announced today that it has submitted its response to the Day 120 List of Questions (LoQs) issued by the Committee for Medicinal Products for Human Use (CHMP) with respect to its Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Further communication from the EMA is anticipated by day 150 under the accelerated review timeline (or day 180 under the standard review timeline if accelerated review is not permitted). At that point, the EMA is expected to either submit an LoOI (List of Outstanding Issues) or issue an opinion on the MAA.
Targacept, Inc. (NASDAQ:TRGT) has been added to the Clinical database and FDA Calendar. A summary of its pipeline is listed below.
TC-5214 – Expect to report top-line Phase 3 results from two fixed dose trials (RENAISSANCE 4 and RENAISSANCE 5) and a long term study designed primarily to evaluate safety (RENAISSANCE 7) in 1H 2012, with a potential NDA filing in 2H 2012 for major depressive disorder (MDD);
TC-5214 – Phase 2b “switch” monotherapy study (known as the EXPLORER study) for patients with MDD who do not respond adequately to initial antidepressant therapy is ongoing.
TC-5619 – Phase 2b study as a treatment for negative symptoms and cognitive dysfunction in schizophrenia is ongoing.
TC-5619 – Topline data from its Phase 2 trial in patients with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) is due in 2H 2012.
TC-6987 – Topline data from its Phase 2 trials of both asthma and type 2 diabetes are expected 1H 2012
AZD3480 – Phase 2b trial for Alzheimer’s disease is ongoing.
AZD1446 – Phase 2 trial for Alzheimer’s disease is planned.
Repligen Corporation (NASDAQ:RGEN) announced its NDA for SecreFlo™ for the improved detection of pancreatic duct abnormalities in patients with pancreatitis will be decided under Priority Review with a PDUFA goal date of June 21, 2012.