|Adventrx To Develop ANX-188; FDA Grants QIDP and Fast Track Designations for Cubist|
|By Staff and Wire Reports|
|Thursday, 28 February 2013 19:45|
ADVENTRX Pharmaceuticals (NYSE: ANX) announced its plans to develop ANX-188 in complications of arterial disease, initially as an adjunct to thrombolytics in acute limb ischemia (ALI), a complication of peripheral arterial disease. Peripheral arterial disease affects an estimated 8 to 12 million people in the United States.
Arterial disease resulting from atherosclerotic and thromboembolic processes is a common circulatory problem in which plaque-obstructed arteries reduce the flow of blood to tissues. Peripheral arterial disease refers to disease affecting arteries outside the brain and heart and often refers to blockage of arteries in the lower extremities. Ischemic cerebrovascular infarction, or stroke, results from blockage of arteries to the brain, while myocardial infarction, or heart attack, results from blockage of arteries to the heart. Thrombolytic agents, such as tPA (tissue plasminogen activator), commonly referred to as "clot busting" drugs, are used to treat acute complications of peripheral arterial disease, heart attack and stroke.
R. Martin Emanuele, Senior Vice President, Development, said: "Data from experimental models demonstrate the potential for ANX-188, when used alone or in combination with thrombolytics, to improve outcomes for patients with thrombotic arterial disease, whether manifesting as acute limb ischemia, stroke or some other variant. Studies in animals and humans suggest that ANX-188 can shorten time-to-thrombolysis, improve blood flow, delay re-occlusion and reduce reperfusion injury, each of which may improve the effectiveness of existing thrombolytic agents."
Santosh Vetticaden, Chief Medical Officer, said: "We plan to evaluate the potential of ANX-188 in arterial disease initially by evaluating it in acute limb ischemia. Near-term goals include seeking orphan drug designation for ANX-188 in ALI, meeting with FDA to discuss our development plan in ALI and, assuming FDA agrees with the plan, initiating a phase 2, clinical proof-of-concept study in late 2013 or early 2014. Currently, we estimate that third-party costs to conduct this study will be approximately $2 million and that it will take approximately 15 to 18 months to enroll. Ultimately, we plan to leverage the data in ALI to find a partner to develop ANX-188 in larger indications within arterial disease, such as stroke."
Conference Call Information The Company will hold a conference call tomorrow, Friday, March 1, 2013, at 8:30 a.m. (ET), 5:30 a.m. (PT) to discuss its development plans in acute limb ischemia. Interested parties may access the conference call by dialing (800) 860-2442 from the U.S. and (412) 858-4600 from outside the U.S. and should request the ADVENTRX Pharmaceuticals Update Call. The webcast will be available live via the Internet by accessing the Events & Presentations page of Investors section of ADVENTRX's website at http://www.adventrx.com/investors/events/. Replays of the webcast will be available on the Company's website for 30 days and a phone replay will be available through March 6, 2013 by dialing (877) 344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and entering conference reference number 10025903.
Cubist Pharmaceuticals (NASDAQ: CBST) announced that the U.S. Food and Drug Administration (FDA) has designated the company's late-stage antibiotic candidate, ceftolozane/tazobactam, as a Qualified Infectious Disease Product (QIDP) for the indications of Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI).
Additionally, the company received from the FDA notification that Cubist's antibiotic candidates, ceftolozane/tazobactam and surotomycin, have been granted Fast Track status in their previously granted QIDP indications, Complicated Intra-Abdominal Infections (cIAI) and Clostridium difficile-Associated Diarrhea (CDAD) respectively.
“We are excited to receive the QIDP and Fast Track designations for ceftolozane/tazobactam and surotomycin, which further reinforce the importance the FDA places on helping to advance critically needed antibiotics,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “In a very short period of time, the GAIN Act has shown its value in helping to incentivize antibiotic development.”
The QIDP designation for ceftolozane/tazobactam will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for Fast Track status, and if ceftolozane/tazobactam is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which received strong bipartisan support in Congress and was signed into law by President Obama in July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth authorization of the Prescription Drug User Fee Act.
Ceftolozane/tazobactam is currently being studied in pivotal Phase 3 trials as a potential first-line intravenous therapy for the treatment of cIAI and cUTI caused by Gram-negative pathogens, including those caused by multi-drug resistant Pseudomonas aeruginosa. Cubist expects to initiate a Phase 3 VABP program for ceftolozane/tazobactam by mid-year. Surotomycin, a rapidly bactericidal lipopeptide, is currently in Phase 3 being studied as a potential treatment for patients with a severe and sometimes life-threatening diarrhea caused by CDAD.
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