Clinical Study of Maxamine


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Maxim Pharmaceuticals Expands Testing of Maxamine in Hepatitis C
SAN DIEGO---(BW HealthWire)---April 3, 2000--Maxim Pharmaceuticals (AMEX:MMP) (SSE:MAXM) announced the initiation of a clinical study to evaluate the safety of triple-drug therapy incorporating the company's lead drug, Maxamine(R), in patients with chronic hepatitis C infection.

The study will evaluate the safety of treatment with Maxamine in combination with the immunotherapeutic agent interferon-alpha and the anti-viral drug ribavirin in 15 hepatitis C patients who were nonresponsive to prior therapy. The clinical study is being conducted at the Kaplan Medical Center, Israel.

Maxim also announced that it expects to commence by mid-year a clinical study to evaluate the safety of Maxamine in combination with pegylated (sustained release) interferon for the treatment of hepatitis C patients. Moreover, the company announced that the 24-week results from its 129-patient dose-ranging clinical study of Maxamine and interferon-alpha for the treatment of hepatitis C have been accepted for presentation on April 12, 2000 at the 10th International Symposium on Viral Hepatitis and Liver Disease sponsored by the U.S. Center for Disease Control and Prevention to be held in Atlanta. All three studies are intended to position Maxamine for the commencement of advanced clinical studies in hepatitis C by the end of this year.

"The interim results reported late last year from our ongoing Phase II hepatitis C trial suggest that Maxamine may substantially improve the efficacy of interferon-alpha in the treatment of hepatitis C," said Kurt R. Gehlsen, Maxim's vice president, development and chief technical officer. "Maxamine may have the potential to benefit a number of existing and proposed treatments for hepatitis C using immunotherapy, regardless of whether that treatment consists of interferon, pegylated interferon or any form of interferon administered in combination with anti-viral drugs. These two new trials are designed to facilitate more advanced testing of Maxamine in combination with a broad range of complementary drugs. We are pleased that as a result of the growing interest in Maxamine both new safety trials will be funded by our collaborators."

Maxim is currently conducting a 129-patient, dose-ranging clinical study of the combination of Maxamine and interferon-alpha in the treatment of chronic hepatitis C. This ongoing study is designed to determine the most appropriate dose regimen for Maxamine, and to evaluate the efficacy of combination immunotherapy using Maxamine in the treatment of chronic hepatitis C.

In late 1999, the company reported that after 12 weeks of treatment, 72% of the patients treated with Maxamine in combination with interferon-alpha attained a complete biochemical and viral response. Published reports suggest that no more than 20-30% of patients with similar profiles achieve a complete biochemical and viral response when treated for 12 weeks with interferon alone. Maxamine, however, is an investigational drug and safety and efficacy have not been established at this time. The 24-week clinical results from the ongoing study have been accepted for presentation April 12, 2000 at the 10th International Symposium on Viral Hepatitis and Liver Disease.

Hepatitis C
Hepatitis C is more easily transmitted than HIV and is now 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 more than 200 million people are infected worldwide.

Hepatitis is a disease characterized by inflammation of the liver and, in many cases, permanent cirrhosis (scarring) of the liver tissues and mortality. 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 often given in combination with the anti-viral drug ribavirin. The majority of patients do not attain a sustained response with current therapies.

Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body's immune system to fight cancer and certain infectious diseases.

Maxamine protects critical immune cells and is administered in combination with cytokines, a class of proteins such as interleukin-2 and interferon-alpha that stimulate these same immune cells. More than 1,000 patients have been treated in the company's completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.

Maxim Pharmaceuticals is developing advanced drugs, therapies and vaccines for cancer and infectious diseases. The Company's lead drug candidate, Maxamine, is currently being tested in three Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Maxim expects to file its NDA and report results for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in mid 2000.

Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. The company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. The company's third platform technology, MaxVax(TM), now in preclinical development, utilizes a needle-free mucosal vaccine carrier/adjuvant system for a broad range of infectious diseases. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.

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 Maxamine and 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 efficacy in larger-scale clinical trials and the risk that the company will not obtain approval to market its products. These factors and others are more fully discussed under "Risk Factors" and elsewhere in the company's periodic and other reports as filed with the Securities and Exchange Commission.

Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), MaxVax(TM), and the Maxim logo are trademarks of the company
Editor's Note: This release is also available on the Internet at
Maxim Pharmaceuticals
Larry G. Stambaugh or Dale A. Sander, 858/453-4040 or Burns McClellan; Ethan Denkensohn or Justin Jackson, 212/213-0006

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