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NEW YORK, May 13 /PRNewswire/ -- The recent excitement over EntreMed Inc., whose stock price zoomed 600 percent on reports of its success killing tumors in mice, has focused media and investor attention on companies involved in cancer research, notes Dirks & Co. analyst Karen Lazarovic. As a result, she predicts pharmaceutical companies with promising drugs farther along in the FDA approval process are likely to benefit from this heightened attention.

A prime example, says Ms. Lazarovic, is Maxim Pharmaceuticals (Amex: MMP). In her biotech report just released to investors, she states that the company's drug, Maxamine, which is in three Phase III trials (the final stage of testing before FDA approval), is showing great promise in prolonging the lives of patients with malignant melanoma and acute myelogenous leukemia. Melanoma, or skin cancer, is a leading cause of cancer deaths and strikes approximately 40,000 Americans and 125,000 people worldwide each year. The company is planning an international launch of the product by late 2000. Meanwhile, EntreMed estimates that they will not even begin human clinical trials for 12-18 months.

"One of the real risks facing investors is the difficulty some drugs encounter making the transition from mice to men," Lazarovic says. "Maxamine's success is based on its effectiveness as an enabler for interferon-alpha and interleukin-2, two drugs that have fallen short of expectations in humans following great success with mice. They are highly toxic in humans and much less effective in saving lives than anticipated. According to recent statistics, only 15 percent of patients with skin cancer exhibit a positive response to these current immunotherapy drugs."

Maxamine, a histamine salt, is unique in that it increases the effectiveness of IL-2 and interferon-alpha by preventing the phagocytes in malignant tumors from releasing a substance that causes the natural immunity in the body to break down, the report states. In fact, the natural killer (NK) cells in the body are sent into apoptosis, or programmed cell death.

The addition of IL-2 alone increases the number of NK cells, but does nothing to withstand the onslaught of the phagocytes. By adding Maxamine to the immune-therapy program, patients' immune systems are significantly bolstered. For malignant melanoma, Maxamine therapy has more than doubled survival time to over 15 months versus the usual 6 months with conventional treatments, Lazarovic's report states.

Additionally, in Phase II trials for AML, the number one leukemia in adults today, 28 patients treated with Maxamine and IL-2 achieved a significant increase in the duration of remission: more than double the normal standard of care. With Maxamine therapy administered in 21-day cycles after the first clinical remission, the relapse time of the disease was extended from an average of 12 months to in excess of 25, with 70 percent of patients still living in disease-free remission.

After a second relapse of AML, patients usually die after five to six months. With Maxamine therapy, 42 percent of relapse patients are still alive after 31 months.

Lazarovic also reports on another new technology in Maxim's pipeline: MaxVax, a vaccine carrier that can be used to bring antigens directly to the body's mucosal system. Mucosal membranes, such as nose, mouth, and genital organs, are primary sites where infectious agents such as HIV, influenza, and hepatitis B enter the body. Maxim is performing pre-clinical work and results on its first prototype vaccine are expected shortly. Lazarovic believes, "the results will be significant."

The report also relates that interest in preventive health care has accelerated over the past decade and the market for human vaccine products is soaring. In 1991, vaccine revenues totaled $1.67 billion worldwide. By 1999, estimates show a tripling in vaccine sales to $5.3 billion, with annual growth rates of 20 percent.

Maxim's current market capitalization is $147 million. Lazarovic says she "finds this reasonable given the company's outstanding potential." In addition to the above noted indications, Maxamine therapy is in Phase I clinical trials for hepatitis C. "If successful in treating this widely prevalent viral infection (more than 150 million people suffer worldwide)," Lazarovic says, "Maxamine could be a blockbuster drug." Her 12-month target price for MMP is 25.

SOURCE Dirks & Co.

    -0-                             05/13/98
    /CONTACT:  Karen Lazarovic, 212-832-6125, or 800-774-0778 for Dirks & Co./

CO:  Dirks & Co.; Maxim Pharmaceuticals
ST:  New York

-0- (PRN) May/13/98 02:01 EOS (PRN) May/13/98 02:01 86 â -0- (PRN) May/13/ 98 2:16

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