Shares of Ampio Pharmaceuticals Inc. (AMPE) rose more than 8% on Monday to $4.33 following FDA acceptance of the company's Patient Outcome for Premature Ejaculation, or POPE, Questionnaire, paving way for the U.S. pivotal trial on male sexual dysfunction drug Zertane.
The POPE Questionnaire is a unique evaluation tool to assure that the verbal responses of the patients to physician questions following their treatment would accurately reflect their clinical response to the drug, said the company.
ADVENTRX Pharmaceuticals Inc. has begun trading on the NYSE exchange under the new name "Mast Therapeutics, Inc" and ticker "MSTX", effective Monday.
MSTX closed Monday's trading 3.55% higher at $0.76.
Aeterna Zentaris Inc. (AEZS) (AEZ.TO) plunged more than 22% to close at $2.03 on Monday after it announced that an independent Data Safety Monitoring Board has recommended discontinuing the ongoing phase III study of Perifosine in multiple myeloma.
The company noted it remains focused on other opportunities such as its phase III trial in endometrial cancer and phase II trials in breast, prostate and bladder cancer with AEZS-108, its NDA filing for AEZS-130 as an oral diagnostic test for growth hormone deficiency in adults, as well as its earlier-stage oncology compound, AEZS-120.
Cardiovascular Systems Inc. (CSII) surged over 16% to touch a new 52-week high of $19.27 on Monday after reporting that its pivotal ORBIT II Investigational Device Exemption clinical trial evaluating the safety and effectiveness of its orbital atherectomy technology in treating severely calcified coronary arteries met its primary endpoints.
The company plans to submit its Premarket Approval application to the FDA at the end of this month.
The Medicines Company (MDCO) touched a new high of $33.71 on Monday following the presentation of detailed results from a phase III study evaluating its investigational intravenous blood clot preventer Cangrelor in patients with atherosclerosis undergoing percutaneous coronary intervention, or PCI.
In the phase III trial, dubbed CHAMPION PHOENIX, intravenous Cangrelor was compared with the usual treatment of Plavix (oral Clopidogrel) to find out if there were any improved ischemic outcomes in the PCI patients at 48 hours.
According to the trial results, intravenous Cangrelor reduced ischemic events by 22% and the incidence of stent thrombosis by 38% compared to oral Clopidogrel.
In 2009, the company discontinued a phase III program for Cangrelor, which consisted of two large studies, dubbed CHAMPION-PCI study and CHAMPION-PLATFORM, after Cangrelor failed to show superiority to 600 mg clopidogrel given orally for the pre-specified primary endpoint comprising death, myocardial infarction, or ischemia driven revascularization at 48 hours.
The CHAMPION PHOENIX trial was initiated in September 2010.
The company expects to submit New Drug Application for Cangrelor in the second quarter based on the CHAMPION PHOENIX trial results and BRIDGE trial results.
The BRIDGE trial, whose results were reported in Nov.2011, demonstrated that patients receiving Cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive surgical bleeding.
Simcere Pharmaceutical Group (SCR) gained over 16% following the receipt of "going private" offer at $9.56 per American Depositary Share or $4.78 per ordinary share in cash. The proposal has been put forward by a group led by Jinsheng Ren, founder and Chairman of Simcere Pharma. A response to the proposed transaction is yet to be taken by the company.
Tonix Pharmaceuticals Holding Corp. (TNXP.OB) has completed a pre-phase III meeting with the FDA held to discuss its proposed New Drug Application plan for the novel sublingual tablet formulation of cyclobenzaprine for bedtime use, TNX-102 SL, for the management of fibromyalgia. According to the proposed plan of the clinical program, which has been accepted by the FDA, the registrational clinical trials will consist of two randomized, 12-week safety and efficacy studies.
Dosing in the first trial is scheduled to begin in Q3, 2013 with topline data anticipated to become available in the second half of 2014.
by RTT Staff Writer
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