Peregrine Pharmaceuticals Announces Abstracts of Interim Results From Tumor Necrosis Therapy Treatment of Lung and Hepatic Cancers
Data to be Presented At Society of Nuclear Medicine's 49th Annual Meeting, June 15-19, 2002
Peregrine Pharmaceuticals Inc. (Nasdaq:PPHM) today announced that interim data from human clinical studies using Peregrine's proprietary Tumor Necrosis Therapy (TNT) technology will be presented at the Society of Nuclear Medicine's 49th Annual Meeting, June 15 to 19 in Los Angeles.The studies of TNT for lung and hepatic cancer were designed and conducted in the People's Republic of China by various universities independently of Peregrine.
Abstracts titled "Tumor Necrosis Therapy of Lung Cancer using (131)I Labeled Chimeric TNT Antibody" and "Radioimmunotherapy of Patients with Hepatic Cancer using (131)I-chTNT" summarizing preliminary unaudited study results can be accessed on the Society of Nuclear Medicine Web site at http://www.snm.org/am. Abstracts are embargoed for publication until they are presented at the annual meeting.
The abstract "Tumor Necrosis Therapy of Lung Cancer using (131)I Labeled Chimeric TNT Antibody" outlines interim data on 43 patients who were treated under three different protocols. Histology confirmed 30 cases with stage IIIB and 13 cases with stage III inoperable lung cancer.
Patients were randomized into three groups and treated either with (1) iv infusion (n=22); (2) intratumoral injection using CT guided catheter (n=16); and (3) combination iv (25% dose) and intratumoral (75% dose) infusion. All patients received two doses at a two-week interval of radiolabeled TNT totaling 0.8 mCi of radiation per kg body mass. Partial remission (PR) was defined as a greater than 50% reduction in tumor mass in all lesions and complete remission (CR) as no detectable tumor for greater than 10 weeks.
Patients receiving iv injection alone had 2 PR (9%), 16 had stable disease (73%), and 4 progressed (18%). Those receiving intratumoral injection had 1 CR (6%), 8 PR (50%), 7 had stable disease (44%) and 0 progressed. Finally, those in the third group had 1 CR (20%), 1 PR (20%), 2 had stable disease (40%) and 1 progressed (20%). Toxicity was limited to mild and reversible bone marrow suppression in 20 cases.
"We are especially pleased that our colleagues in China have been able to obtain such promising results with lung cancer," said Alan L. Epstein, M.D., Ph.D., co-author of the lung cancer paper, inventor of the TNT technology and Peregrine's scientific consultant.
"Except for surgery for earlier stage patients, there is no effective treatment for this disease. The tumor itself grows in a vital organ and patients therefore have a relatively short survival time. The scientists in China have discovered a new application for TNT that complements Peregrine's ongoing United States trials with brain cancer.
"Specifically, the Chinese have used intratumoral injections of radiolabeled TNT to treat lesions reached by catheter during bronchoscopy to treat unresectable tumors growing in the lung. In this study, intratumoral injection caused substantially higher complete and partial remission rates than the other methods of administration. It also offers the advantage of possibly reducing the systemic toxicity often seen with intravaneous administration of radionuclides."
"While the data gives an overview of less than half of the lung cancer patients treated in China, it gives us a preliminary indication of how well our TNT technology has performed in these patients," said Edward Legere, Peregrine's president and CEO.
"We believe we can learn a lot from the lead researchers in this study and look forward to meeting with them later this year. We are anxious to review more detailed data that may help us design and execute a lung cancer study in the United States utilizing intratumoral drug delivery methods for radiolabeled TNT."
Peregrine's TNT targets DNA-associated antigens in the nucleus of necrotic cancer cells. It is being developed in the United States under the trade name Cotara™ and is currently in a multi-center Phase II clinical study for the treatment of brain cancer. Final preparations are being made to start a multi-center, multi-national Phase III study for brain cancer.
Cotara is also being studied in four Phase I clinical studies for the treatment of colorectal, pancreas, liver, soft tissue sarcoma and biliary cancers. Cotara has received fast track and orphan drug status from the Food and Drug Administration for the treatment of brain cancer.
About Peregrine Pharmaceuticals Inc.Peregrine Pharmaceuticals is a biopharmaceutical company focused on the development, commercialization and licensing of unique technologies for the treatment of cancer, primarily based on its three "collateral targeting technologies."
Peregrine's Tumor Necrosis Therapy (TNT), Vasopermeation Enhancement Agents (VEA) and Vascular Targeting Agents (VTA) target cell structures and cell types that are common among solid tumor cancers, giving them broad applicability across various tumor types.
The company's lead TNT anti-cancer drug, Cotara™, is currently in a multi-center Phase II clinical trial for brain cancer and Phase I trials for colorectal, pancreas, liver, soft tissue sarcoma and biliary cancers. Peregrine's Oncolym®, for the treatment of non-Hodgkin's B-cell Lymphoma, is currently in a multi-center Phase I/II study.
Copies of Peregrine news releases, SEC filings, current price quotes and other valuable information for investors may be found on the Web site, http://www.peregrineinc.com.
Safe Harbor Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the company's expectations as a result of risk factors discussed in Peregrine's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, the company's report on Form 10-K for the year ended April 30, 2001 and on Form 10-Q for the quarter ended Jan. 31, 2002.
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