Posted on: 06/01/2002
Wednesday May 22, 9:31 am Eastern Time
Press Release
SOURCE: SuperGen Inc.
SuperGen's Partaject(TM)-Delivered Busulfan is Safe and Effective in Patients with Neoplastic Meningitis
Results from Phase I clinical trial presented at 38th Annual Meeting of the American Society of Clinical Oncology (ASCO)
DUBLIN, Calif., May 22 /PRNewswire-FirstCall/-- SuperGen Inc. (Nasdaq: SUPG - News) today announced that data from a Phase I clinical study suggest the company's Partaject(TM)-delivered busulfan is safe and effective in patients with neoplastic meningitis. Results of the study were presented yesterday at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando.
Neoplastic meningitis is an end-stage condition where 5 to 30 percent of all solid tumors metastasize to the meninges area of the brain. SuperGen's Partaject delivery system allows compounds that are insoluble or poorly soluble in water to be delivered intravenously (or by other routes) without the need for organic solvents that may in themselves be toxic.
The Phase I study, designed to establish the maximum tolerated dose of a compound, was conducted at the Brain Tumor Center at Duke University and has enrolled 25 patients who are receiving intrathecal doses (injected into the spinal cord) from 2.5 mg up to 21.25 mg. Although the maximum tolerated dose has yet to be identified, and measurement of anti-tumor activity is not the primary objective of the study, there is evidence that Partaject-delivered busulfan is active against neoplastic meningitis. Two patients with primary breast cancer, one patient with primary lung cancer and one patient with glioblastoma (advanced brain cancer) experienced a partial response and five patients experienced stable disease (from 2 weeks to 4 months).
"These results are encouraging, given that neoplastic meningitis is oftentimes the end stage in a patient's struggle with cancer," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "Once the maximum tolerated dose is established, we will accelerate the clinical development of Partaject-delivered busulfan.
"Over the past several decades, busulfan has been a very good and reliable compound. However, the fact that it is insoluble has been a major obstacle for oncologists," added Dr. Rubinfeld. "We believe that the Partaject delivery system, which can overcome the solubility problem, can therefore be of great benefit to cancer patients and doctors alike. We are proud that Partaject- delivered busulfan is one of many products in our broad pipeline designed to treat a variety of solid tumors and hematological malignancies," said Dr. Rubinfeld.
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer.
This press release contains 'forward-looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such forward-looking statements include statements regarding our expectations about Partaject-delivered busulfan and other products. The success of such product could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties. Such factors may include, but are not limited to: risks and uncertainties related to how quickly data can be analyzed to submit an NDA with the FDA, the results of the studies, how lengthy the FDA review process will take, if the application will be accepted, filed, and approved or if either drug will ever reach the market. Reference is made to the discussion of risk factors detailed in the Company's filings with the Securities and Exchange Commission, including the reports on Form 10-K for the year ending 2001 and the report on Form 10-Q for the quarter ending March 31, 2002.
Contacts:
L. Robert Cohen, V.P., Investor Relations & Finance, SuperGen Inc., 800- 353-1075, ext. 111
SOURCE: SuperGen Inc.
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