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FOR IMMEDIATE RELEASE Contact: Dennis Pietronigro, Ph. D. New anti-cancer drug (DTI-015) from Direct Therapeutics shows safety and evidence of activity in treating advanced brain cancerJanuary 24, 2003 (Redwood City, California, USA) — Direct Therapeutics, Inc., a privately held drug development company, reported today the results of two studies of its new anti-cancer drug DTI-015, currently in multi-center human clinical trials for the treatment of brain cancer. DTI-015 is a novel drug product designed for direct injection into solid-tumor cancers. It contains the active ingredient carmustine (also known as BCNU) dissolved in an ethanol solvent carrier vehicle. The results are published today in the January/February 2003 issue of the journal Neoplasia. In these studies, researchers from Direct Therapeutics and the University of Texas M.D. Anderson Cancer Center report detailed results of a human clinical trial conducted at the M.D. Anderson Cancer Center. They showed a doubling of median overall survival time from the expected 25 weeks to 55 weeks for patients with recurrent inoperable glioblastoma multiforme (the most serious and deadly form of brain cancer) who were treated with DTI-015 at or below Maximum Tolerated Dose. In a separate article, the authors also report on the 40% cure rate for rat brain tumors treated with DTI-015 shown in an earlier pre-clinical study. All patients in the M.D. Anderson trial had been heavily treated for their disease before entering the study. Many had undergone two or more surgical procedures, all had received radiation therapy, and most received intravenous chemotherapy with nitrosoureas, a class of drugs to which cancers often develop resistance. “We especially appreciate the efforts of physicians at the M.D. Anderson Cancer Center to evaluate DTI-015, which we feel could become an important new treatment option for patients with this devastating disease,” said Edward E. Luck, president and chief executive officer of Direct Therapeutics. “Results of our own multi-center Phase I/II trials of heavily pretreated glioblastoma multiforme patients have also been positive, and we look forward to expanding our clinical experience with DTI-015 as our European study of patients with newly diagnosed high-grade gliomas moves forward.” Direct Therapeutics will complete final analysis of its Phase I/II trial after all clinical data has been gathered. The company is currently preparing the protocol for its Phase III study of DTI-015. Carmustine (1-3 bis [2-chloroethyl]-1-nitrosourea), a cytotoxic chemotherapeutic agent from the nitrosourea family, is commonly used to treat brain tumors by intravenous injection, a method that exposes the whole body to the serious toxicities of the drug. DTI-015, in contrast, is injected directly to brain tumors using standard image-guided stereotactic injection, a minimally invasive surgical procedure similar to that used for obtaining brain tumor biopsies. The ethanol solvent carrier vehicle in DTI-015 transports the carmustine selectively throughout the tumor mass and into both the aqueous and lipid compartments of tumor cells. As a result, DTI-015 rapidly, thoroughly, and selectively saturates tumor tissue with high doses of carmustine not achievable by other means while at the same time minimizing whole body exposure to the drug. Importantly, none of the forty patients receiving DTI-015 exhibited the systemic toxicity typical of intravenously administered carmustine. According to the American Cancer Society, there are 36,000 new cases of primary brain cancer diagnosed each year in the United States. Nearly all patients with glioblastoma multiforme, the most common and aggressive form of brain cancer, die from the disease or its complications within two years of first diagnosis. ############# About Direct Therapeutics Direct Therapeutics, Inc. is a privately held drug development company using its patented Solvent-Facilitated Perfusion technology to develop drugs for the localized treatment of solid tumor cancers and other diseases. DTI-015, the company’s first product, has received Orphan Drug Designation in both the United States and the European Union. Last year, Direct Therapeutics was awarded a highly competitive Small Business Innovation Research grant by the National Institutes of Health, which the company is using to map the anti-tumor activity of DTI-015 in brain tumors using non-invasive imaging technology. For more information about Direct Therapeutics, please contact us or visit www.directtherapeutics.com. About Neoplasia Neoplasia is an international journal published by Neoplasia Press Inc. covering the lastest research results in all areas of cancer research. Published bimonthly, Neoplasia contains cutting-edge articles that keep researchers up-to-date in all the traditional disciplines of oncology research as well as emerging fields and interdisciplinary investigations including new molecular and genetic findings related to the neoplastic phenotype. The two articles about Direct Therapeutics’ drug DTI-015 are published in Vol. 5, Number 1, January – February 2003 of Neoplasia: “Stereotactic injection of DTI-015 into recurrent malignant gliomas : phase I/II trial” by Samuel J. Hassenbusch, Emilio M. Nardone, Victor A. Levin, Norman Leeds, and Dennis Pietronigro (Neoplasia, 2003; 5: 9 – 16) “DTI-015 produces cures in T9 gliosarcoma” by Dennis Pietronigro, Frank Drnovsky, Humberto Cravioto, and Joseph Ransohoff (Neoplasia, 2003; 5: 17 – 22) are attached. For further information about Neoplasia, visit: www.neoplasia.com
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