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Posted: November 28, 2007
Supratek Pharma Inc. Announced Agreement With The FDA For Study Protocol Of Nanomedicine Drug
(Nanowerk News) Supratek Pharma Inc. announced today that under the Special Protocol Assessment (SPA) process, it has obtained agreement with the United States Food and Drug Administration (FDA) for the design of its pivotal study protocol for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract.
The randomized, multicenter Phase III pivotal
clinical trial will compare SP1049C plus Best Supportive Care (BSC) versus BSC
alone for the treatment of patients with advanced adenocarcinoma of the
esophagus, gastroesophageal junction and stomach who have failed adjuvant or
1st or 2nd line chemotherapy. Supratek Pharma is the sponsor of the
international trial and its Clinical Oncology team will direct the clinical
Oleg Romar, President and Chief Executive Officer, said, "We are pleased
that the FDA has accepted our Phase III clinical protocol for SP1049C. This
acceptance is a significant milestone and represents a critical step in the
advancement of our clinical program. We believe that SP1049C, a novel
anthracycline, may be a breakthrough treatment for this patient population.
FDA's agreement in writing to a protocol reviewed under this process is
considered binding on the review division of the FDA, providing that the
protocol is followed and no substantial scientific issues arise regarding the
safety or efficacy of the drug after the testing has begun."
"In the SPA communication, the FDA advised that the clinical design and
analysis plan of our submitted protocol are suitable to provide evidence of
safety and efficacy to support a new drug application (NDA) for SP1049C for
the treatment of cancer of the upper gastrointestinal tract," said Dr.
Christopher E. Newman, Vice President and Chief Medical Officer of Supratek
Pharma. "The protocol for this trial was optimized with contributions from
world opinion leaders in oncology. We look forward to the launching of this
important pivotal study."
Supratek's proprietary lead anticancer drug candidate, SP1049C, is the
most advanced nanomedicine drug candidate that is based on polymer technology.
This drug is a Biotransport(TM) composition of poloxamers with one of the most
potent cytotoxic drugs, doxorubicin. SP1049C has been shown, in pre-clinical
and clinical development, to have much higher efficacy and a novel mechanism
of action against chemoresistant tumors in which the original drug is
inactive. SP1049C has also obtained an Orphan Drug designation from the FDA
for the treatment of esophageal carcinoma.
About Supratek Pharma Inc.
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 biochemical pathway and target consistently
involved in metastasis formation and cancer progression. SP-MET-X1, the first
drug developed in this new therapeutic class, is a novel use of an existing
non-cancer drug that is specific to the new validated target.