MONTREAL ¿ Following promising preclinical results, Supratek Pharma Inc. entered its lead anticancer compound, SP1049C, into a Phase I dose-escalating study.

Oleg Romar, president and CEO of Supratek, told BioWorld International SP1049C has demonstrated a new mechanism of action and efficacy against various drug-resistant and metastatic tumors. It succeeded in nine of nine in vivo tumor models that were evaluated according to U.S. National Cancer Institute-recommended efficacy criteria.

In preclinical studies SP1049C showed it was extremely effective in accumulating directly in the nuclei of tumor cells, indicating the novel drug has distinctive features not found in multidrug-modulating agents, drug-polymer conjugates or liposomal drug-delivery systems, Romar said.

¿The properties that we have identified to date make SP1049C unique among chemotherapeutic agents and give it the potential of becoming the primary cytotoxic agent of choice in the treatment of a variety of cancers,¿ he said

The Phase I study, to be carried out at two centers, will determine the maximum tolerated dose of intravenous administration of SP1049C in patients with advanced cancer. In addition, the study will determine the pharmacokinetic profiles of the compound and identify the dose-limiting toxicity. A secondary objective is to evaluate the anti-tumor effect of SP1049C.

Supratek¿s platform Biotransport carrier technology, on which its anticancer drug is based, provides a dual function for drug discovery and development. The carriers combine unique mechanisms of action for targeting and biological-response modification by improving the biological activity of conventional and biotechnology drugs without changing their molecular structure. Since Biotransport is based on highly flexible and manageable chemistries, the technology is applicable to a wide variety of both conventional and biotechnology drugs, including gene therapy. ¿ Peter Winter