Caprion Pharmaceuticals Receives FDA Fast Track Designation For Shigamabs Clinical Program
Published: May 11, 2006
The FDA cited the following reasons for granting Fast Track designation:
Hemolytic uremic syndrome (HUS) is a serious condition that may result from infection with Shigatoxin-producing bacteria. There are currently no therapies available for the prevention of HUS in infected patients, and therefore, the Shigamabs antibodies to Shigatoxins 1 and 2 have the theoretical potential to address this unmet medical need. "We are pleased with the Fast Track designation for Shigamabs," stated Dr. Marc Riviere, Caprion's Executive Vice-President of Clinical Development. "Based on our clinical results to date, we believe that Shigamabs is a well-positioned candidate to become the first therapy for this significant unmet medical need."
The Fast Track program is designed by the FDA to facilitate the development and expedite the review of drugs and biologics that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The designation means that the candidate could be eligible for priority review of the Biologics License Application (BLA), submitting portions of the BLA prior to completion of the entire application, and accelerated approvals. An important feature of the Fast Track designation is to emphasize the close and early communication between the FDA and the company to improve the efficiency of product development.
Shigamabs is a single, intravenously administered product that consists of two monoclonal antibodies: caStx1 and caStx2. Shigamabs is being developed for the treatment of Shigatoxin-producing bacterial infections, the most common of which is caused by Shigatoxin-producing E. coli (STEC). STEC is transmitted by contaminated food or water and is responsible for such outbreaks as the one in Walkerton, Ontario in May 2000. STEC affects an estimated 250,000 people annually in Industrialized Countries. In 50% of people that experience Shigatoxin-mediated events, clinical outcomes include hemolytic anemia, thrombocytopenia, kidney failure, brain damage, and for 2% to 3% of such patients, death. There is currently no approved treatment for STEC infections.
Preclinical animal models have demonstrated the efficacy of Shigamabs and Phase I trials have further shown the antibodies to be independently safe and well tolerated in healthy volunteers. A third Phase I trial which will investigate the two antibodies as a single injection in healthy volunteers is expected to be completed in the third quarter of 2006. A pivotal Phase II/III trial is expected to be initiated by the first quarter of 2007. The FDA and European Medicines Agency (EMEA) have both granted Orphan Drug Status to Shigamabs for the treatment of Shigatoxin-producing bacterial infections, which may provide an accelerated regulatory path and grant certain market exclusivities.
About Caprion Pharmaceuticals Inc.
Caprion Pharmaceuticals Inc. is a clinical-stage biotechnology company developing pharmaceutical products in the areas of infectious disease and oncology. CellCarta®, Caprion's proprietary proteomics technology, provides Caprion with an effective means to identify novel drug targets, predict which therapeutics may be safer and more efficacious and, in certain cases, identify which patients may benefit most from a particular therapy.
Caution Concerning Forward-Looking Statements
This press release may contain forward-looking statements about the objectives, strategies, financial conditions, results of operations and businesses of Caprion. These statements are forward-looking as they are based on our current expectations, as of the date of this press release, about our business and the markets we operate in, and on various estimates and assumptions. Our actual results could materially differ from our expectations if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. As a result, there is no assurance that any forward-looking statement will materialize. Risks that could cause our results to differ materially from our current expectations include, among others, the uncertainties related to clinical trials and product development, the market acceptance and commercialization, the government regulations and the Fast Track designation. We disclaim any intention or obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason.
Contact: Caprion Pharmaceuticals Inc. Nathalie Uson, 514-940-3617
Source: Caprion Pharmaceuticals Inc.