MONTREAL, Oct. 26 /CNW/ - The IND proposes a randomized Phase III pivotal
clinical trial that 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 Sponsor of the IND and
will direct the clinical development program. The Company will initiate the
clinical trial after completion of a Special Protocol Assessment (SPA) which
is currently ongoing.
Oleg Romar, President and Chief Executive Officer, said, "The IND
clearance by the FDA is a significant and exciting milestone in the clinical
development program of our lead product. SP1049C is first among our unique
family of nanomedicines. We believe that our Biotransport(TM) polymers'
ability to provide novel mechanisms of action to drugs that have gone through
clinical development, greatly speeds the overall development time, reduces
risk and builds on approved platforms".
"The IND brings Supratek Pharma one step closer to creating an effective
treatment for patients with metastatic disease who have failed available
therapies and for whom no approved salvage therapies exist. We are dedicated
to the clinical development of our product pipeline and to our commitment to
provide novel therapeutics against drug resistant and metastatic cancers",
said Dr. Christopher E. Newman, Vice-President and Chief Medical Officer of
Supratek's lead anticancer drug candidate, SP1049C, is based on
Biotransport(TM) polymer technology. This drug is a proprietary composition of
poloxamers with one of the most potent cytotoxic drugs, doxorubicin.
Doxorubicin is among the most widely utilized anticancer drugs but is limited
in its clinical use by inherent or induced drug resistance. While SP1049C
retains the fundamental therapeutic characteristics of doxorubicin, it has
been shown to have much higher efficacy and a novel mechanism of action
against tumors in which the original drug is inactive. SP1049C has also
received an Orphan Drug designation from FDA for the treatment of esophageal
About Supratek Pharma Inc.
Supratek Pharma is a 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.
For further information:
For further information: Oleg Romar, President and Chief Executive
Officer, Supratek Pharma Inc., Phone: (514) 849-6094 ext. 102, e-mail: