Maxim Advances Enrollment of Ceplene Phase 2 Clinical Trial in Hepatitis C Nonresponder Patients
Data Safety Monitoring Board Reports Interim Safety Review and Recommends that Maxim Complete Phase 2 Clinical Trial of Ceplene(TM) Triple-Drug Combination Therapy
SAN DIEGO--(BUSINESS WIRE)--Sept. 10, 2002-- Maxim Pharmaceuticals (Nasdaq:MAXM - News; SSE:MAXM) today announced that the Data Safety Monitoring Board (DSMB) responsible for reviewing its Phase 2 trial of Ceplene (histamine dihydrochloride) for the treatment of hepatitis C nonresponder patients has concluded that there have been no safety concerns associated with the triple-drug combination of Ceplene, Peg-Intron® (peginterferon alfa-2b) and Rebetol® (ribavirin, USP).
The randomized, controlled Phase 2 study is designed to compare the treatment of nonresponder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron and Rebetol versus treatment with Peg-Intron and Rebetol combination therapy alone. The study will include up to 282 patients who failed to respond to prior therapy with the combination of interferon-alpha and ribavirin. The DSMB reported to Maxim that it has reviewed the safety data through 12 weeks of treatment for the first 41 patients enrolled in the trial, and has concluded that there have been no safety concerns and that the trial should proceed under its approved protocol.
"This report from the DSMB is an important step in the development of Ceplene as this study represents the first time that Ceplene has been administered in humans in combination with Peg-Intron and Rebetol for the treatment of hepatitis C," said Philippe Prokocimer, M.D., Maxim's Vice President of Drug Development. "As with any new drug combination, patient safety is a primary concern. We are pleased that initial results from this large Phase 2 study support the feasibility of adding Ceplene to the current standard of care in an attempt to improve the treatment of hepatitis C patients who have failed prior treatments."
The DSMB includes world-leading clinicians experienced in the treatment of hepatitis C who review the safety data from this Phase 2 clinical trial on an ongoing basis. Maxim is conducting the Phase 2 trial under an agreement whereby Schering Corp., a division of Schering-Plough Corp., is contributing two of its products, Peg-Intron and Rebetol, and performing the viral testing for the study.
The Maxim Phase 2 trial is designed to evaluate the Ceplene triple-drug combination therapy for the treatment of nonresponder patients infected with hepatitis C who failed to respond to prior therapy. Patients will be treated for up to 48 weeks and followed for an additional 24 weeks after completion of treatment. The primary measures of efficacy in the study are sustained complete viral response and sustained biochemical response (normalization of the liver enzyme ALT, a standard measure of liver function) at 72 weeks. The trial is being conducted in Western Europe and Israel.
Hepatitis C
Hepatitis C is the leading blood-borne infection in the United States. The U.S. Center for Disease Control and Prevention estimates that over 4.5 million Americans are infected with the hepatitis C virus. The World Health Organization and other sources estimate that at least 200 million people are infected worldwide. Hepatitis C is a viral infection in which oxidative stress causes inflammation and tissue damage in the liver and, in many cases, permanent cirrhosis (scarring). The cycle of disease from infection to significant liver damage can take 20 years or more. Some experts estimate that without substantial improvements in treatment, deaths from hepatitis C will surpass those from HIV. Hepatitis C is the leading cause of liver cancer and the primary reason for liver transplantation in many countries.
The standard treatment for hepatitis C is interferon-alpha, an immunotherapeutic agent given in combination with the anti-viral drug ribavirin. The most recent advance in hepatitis C therapy approved for sale is a pegylated, or sustained release, formulation of interferon-alpha given in combination with ribavirin. Even with recent advances, approximately half of patients still do not attain a sustained response with current therapies.
"While we need to continue to improve the treatment available to all hepatitis C patients, the largest unmet need today is patients who have failed prior therapy," stated Larry G. Stambaugh, Maxim's Chairman and Chief Executive Officer. "The steady accumulation of patients over the past several years who have failed existing therapies has resulted in a large population of patients in need of the next generation of treatment, and this group is the focus of our current Phase 2 trial."
Overview of Ceplene and Maxim Pharmaceuticals
Research has shown that oxygen free radicals released by certain immune cells can suppress the immune system and damage normal tissue, a process commonly referred to as oxidative stress. Oxidative stress, implicated in numerous diseases, is most pronounced in the liver and can damage or destroy liver tissue in patients with hepatitis and other chronic liver diseases.
Ceplene, based on the naturally occurring molecule histamine, has been shown in preclinical work to prevent the production and release of oxygen free radicals, thereby reducing oxidative stress. Accordingly, treatment with Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.
In addition to hepatitis C, Ceplene is currently being tested in Phase 3 clinical trials for advanced metastatic melanoma and acute myelogenous leukemia, and Phase 2 trials of Ceplene have been completed in advanced renal cell carcinoma (kidney cancer). Clinical trials are also planned in chronic liver diseases such as nonalcoholic steatohepatitis (NASH) and alcoholic liver disease (ALD). More than 1,400 patients have participated in the company's completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers, hepatitis C and other chronic liver diseases. Maxim's research and development programs are designed to provide hope to patients most in need by developing safe and effective product candidates that extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
In addition to Ceplene, Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. Furthermore, the company's MaxDerm(TM) technology is designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, the apoptosis modulator compounds and MaxDerm, and regarding the Company's clinical trials. Such statements are only predictions and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the Company will not obtain approval to market its products, the risk that clinical trials may not commence when planned, and the risks associated with the dependence upon collaborative partners. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company.
Editor's Note: This release is also available on the Internet at maxim.com.
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Contact:
Maxim Pharmaceuticals, San Diego
Larry G. Stambaugh, 858/453-4040
Chairman, President and CEO
or
Burns McClellan (Investors)
John Nugent, 212/213-0006
or
Coffin Communications Group (Media)
Sean Collins/Valerie Bent, 818/789-0100
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Source: Maxim Pharmaceuticals |
