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Direct Therapeutics, Inc. is a development-stage pharmaceutical
company using its patented Solvent-Facilitated Perfusion technology to
create new drugs for the localized and regional treatment of solid-tumor
cancers. Our products are designed for direct injection to target tissue
with minimal invasion of healthy tissue. They contain active ingredients
in organic solvent vehicles that facilitate the penetration of the drug
throughout tumor tissue and into tumor cells. In contrast to "sustained
release" or "controlled release" products, our products
rapidly, selectively, and thoroughly saturate tumors with doses of potent
chemotherapeutic agents unachievable by other means. We have demonstrated
that these products, when directly applied by needle or catheter to solid
tumors, perfuse preferentially throughout the tumor, leading to rapid,
selective death of cancerous tissue.
We have completed two Phase I/II studies of our lead
product, DTI-015 in the United States for the treatment of brain cancer,
and will start our first European trial of DTI-015 in Q1 2003. In November
2002 , we received notice from the US FDA that the company had satisfied
the necessary requirements to initiate a Phase III product-registration
trial of DTI-015 in patients with glioblastoma multiforme, the most common
and deadly form of brain cancer. In addition, we are pursuing development
of new Solvent-Facilitated Perfusion products, which have shown positive
results in pre-clinical studies. |