MONTREAL, April 1 /PRNewswire/ - Supratek Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SP1049C for the treatment of gastric cancer.
Orphan drug refers to a product that is intended for use in a disease or condition that affects fewer than 200,000 individuals in the United States. According to the US National Cancer Institute it is estimated that 21,500 new cases of gastric cancer will be diagnosed in USA in 2008. Throughout the world, however, gastric cancer is the second leading cause of cancer-related deaths.
Last year Supratek Pharma obtained FDA clearance for its Investigational New Drug application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract. Recently Supratek has also reached an agreement with the FDA for the design of SP1049C pivotal Phase III study protocol under the Special Protocol Assessment process. A randomized Phase III pivotal clinical trial will compare SP1049C plus Best Supportive Care (BSC) versus BSC alone for the treatment of patients with metastatic adenocarcinoma of esophagus, gastroesophageal junction and stomach who have failed adjuvant or 1st or 2nd line chemotherapy. Supratek Pharma will direct the clinical development program.
Oleg Romar, President and Chief Executive Officer, said, "Acquiring an orphan drug designation in gastric cancer is a welcome milestone for the SP1049C program". "Orphan drug designation provides multiple incentives for Supratek Pharma to continue its development of SP1049C for metastatic adenocarcinoma of the upper gastrointestinal tract. Our experience to date with SP1049C has been very encouraging and we look forward to the initiation of our Phase III pivotal clinical trial", added Dr. Christopher E. Newman, Vice-President and Chief Medical Officer of Supratek.
About SP1049C
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SP1049C, Supratek's proprietary lead anticancer drug candidate, is a Biotransport(TM) nano-composition of block copolymers and one of the most potent cytotoxic drugs, doxorubicin. In pre-clinical and clinical development, SP1049C has been shown to have a strong activity and a novel mechanism of action against chemoresistant tumors, in which conventional chemotherapeutics are inactive. In 2005 SP1049C has also obtained an orphan drug designation from the FDA for the treatment of esophageal carcinoma.
About Supratek Pharma Inc.
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Supratek Pharma is an emerging pharmaceutical company focused on the treatment of drug resistant and metastatic cancers. The company has seven clinical-stage proprietary products in its pipeline. The next product in line for clinical development is SP-MET-X1. It is based on the Company's potential breakthrough discovery of a new biochemical pathway and target consistently involved in metastasis formation and cancer progression. SP-MET-X1, the first drug developed in this new therapeutic class. Late-stage metastatic cancers account for the majority of cancer deaths and represent one of the major unmet medical needs world-wide.
CONTACT: Dr. Christopher E. Newman, Vice-President and Chief Medical
Officer, Supratek Pharma Inc., Phone: (514) 849-6094, e-mail:
chris.newman@supratek.com
