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FOR IMMEDIATE RELEASE Contact: Clarice Merrill, DIRECT THERAPEUTICS AWARDED SBIR GRANT(Redwood City, CA, June 11, 2001) – Direct Therapeutics Inc., (DTI), a privately-held drug development company, today announced that the National Institutes of Health (NIH) has awarded the company a Small Business Innovation Research (SBIR) grant for the development of techniques to evaluate the distribution of its DTI-015 product candidate for the treatment of brain tumors. DTI-015 is currently in two Phase I/II trials in patients diagnosed with glioblastoma multiforme (GBM), the most common form of primary brain cancer. There are approximately 18,000 primary brain tumors diagnosed annually in the U.S. GBM is one of the most rapidly progressive and uniformly fatal of all cancers, underscoring the urgent need for new, more effective treatments. In addition, each year approximately 100,000 cases of other forms of cancer will metastasize to the brain. Improved therapies coupled with better imaging information would provide important opportunities to individualize treatments which could potentially increase survival. The central hypothesis of the research sponsored by this SBIR grant is that the administration of DTI-015 locally to the tumor can be monitored noninvasively with MRI to measure spatial delivery for correlation with therapeutic outcome. This is particularly important since mortality from brain tumors is most often due to failure to achieve local control of the disease rather than to metastatic or distant recurrent disease. "This SBIR grant will support the development of new methods for targeting and assessing delivery of DTI-015 to GBM sites within the brain, and for evaluating the effects of DTI-015 on tumor blood flow," said Dennis Pietronigro, Ph.D., DTI’s Chief Science Officer. "Our goal for this phase of the research program is to develop reliable methods for mapping the effective distribution of DTI-015, which we plan to use as a basis for the development of non-invasive drug targeting and mapping techniques." The SBIR-funded research will be carried out by DTI in conjunction with Kirk A. Frey, M.D., Ph.D., Professor of Radiology and Neurology and Director, PET Neuropharmacology Laboratory at the University of Michigan, and Brian D. Ross, Ph.D., Associate Professor, Departments of Radiology and Biological Chemistry at the University of Michigan Medical Center. DTI-015 is a unique product that contains the chemotherapeutic drug carmustine, also known as BCNU, dissolved in absolute ethanol. Solvent-facilitated perfusion of BCNU enables the drug to enter both the aqueous and lipid compartments of the targeted tissue, thus achieving rapid drug saturation of the tumor and selective elimination of cancer cells. DTI-015 is administered to the brain by image-guided stereotactic injection directly into the tumor, maximizing therapeutic effect while minimizing systemic toxicity and surgical intervention. In addition to DTI-015, Direct Therapeutics is evaluating several product candidates that contain alternative chemotherapeutic agents and solvents. DTI is also applying its technologies to the development of localized or regional treatments for brain metastases, liver, lung, breast and prostate cancers. Direct Therapeutics, Inc. is a drug development company using its proprietary solvent-facilitated perfusion technology to address the delivery and distribution of drugs for the localized and regional treatment of cancer. Its technology encompasses the development of new products containing anticancer drugs and certain organic solvents that facilitate the penetration of drug throughout tumor tissue and into tumor cells. |