BRAIN CANCER DRUG GETS ORPHAN DRUG DESIGNATION FROM EMEA.

Direct Therapeutics, Inc., Redwood City, Calif., a privately held drug development company, has announced that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted Orphan Drug designation to DTI-015 (carmustine, intratumoral), a novel anti-cancer agent designed for direct injection to malignant brain tumors. DTI-015 is currently in human clinical trials in the United States for the treatment of glioblastoma multiforme (GBM), the most common and deadly form of brain cancer.

Orphan Drug designation in the European Union provides a 10-year period of post-approval marketing exclusivity and other financial incentives for new drugs that offer significant therapeutic advantage over other approved treatments of rare conditions (conditions affecting no more than 5 in 10,000 persons). Direct Therapeutics received Orphan Drug designation for DTI-015 in the United States in 2000.

"We are pleased that the EMEA recognizes the potential for DTI-015 to extend survival time for patients with this devastating disease," said Edward E. Luck, president and CEO of Direct Therapeutics.

DTI-015 is a unique product that contains the chemotherapeutic drug carmustine, also known as BCNU, dissolved in absolute ethanol. DTI-015 rapidly, thoroughly, and selectively saturates tumor tissue with significantly higher doses of carmustine than are possible by other means. Solvent-facilitated perfusion of carmustine with ethanol enables the drug to enter both the aqueous and lipid compartments of the target tissue. The drug is administered by image-guided stereotactic injection directly into the tumor, maximizing therapeutic effect while minimizing the severe toxicities associated with the systemic injection of carmustine.

To date, 66 patients have been treated with DTI-015 in multi-center Phase I/II trials of standard dose-escalation design. Twenty-six patients with recurrent inoperable glioblastoma multiforme have been treated in the trial sponsored by Direct Therapeutics. An additional 40 patients with recurrent inoperable high-grade gliomas (a broader category of highly malignant brain tumors that includes GBM) have been treated in a trial sponsored by physicians at the University of Texas M.D. Anderson Cancer Center in Houston. Analysis of the results from these ongoing studies indicates that patients with recurrent inoperable GBM have shown a median overall survival time of 45 weeks, nearly twice the well-established 25-week median survival time common for patients whose disease has recurred.

According to the American Cancer Society, there are nearly 36,000 new cases of primary brain cancer diagnosed each year in the United States. Nearly all of the patients with glioblastoma multiforme, which accounts for 10-30% of all intracranial tumors and 50-60% of all gliomas, die from the disease or its complications within two years of diagnosis.

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 tumors. The company is nearing completion of its Phase I/II trial of DTI-015 and is planning for its upcoming Phase III trial. The company is planning additional human clinical trials of DTI-015 in the U.S. and Europe for patients with newly diagnosed GBM. 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 develop technologies for mapping the anti-tumor activity of DTI-015 in brain tumors using non-invasive imaging techniques.

For more information, visit http://www.directtherapeutics.com. or call 650/306-1270, ext. 4.