Supratek Pharma Inc. announced FDA clearance for its IND application for SP1049C for the treatment of metastatic adenocarcinoma

30-Oct-2007

Supratek Pharma Inc. announced that the U.S. food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract. 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.

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 carcinoma.

https://www.bionity.com/en/news/72567/supratek-pharma-inc-announced-fda-clearance-for-its-ind-application-for-sp1049c-for-the-treatment-of-metastatic-adenocarcinoma.html