Maxim Pharmaceuticals Reports Clinical Data Demonstrating Significant Increase In Disease-Free Survival In Acute Myelogenous Leukemia (AML) Patients

December 02, 1997

- Updated Data Also to be Presented at 1997 American Society of Hematology (ASH) Conference -

- Phase III Trials to Begin in Early 1998 -

San Diego, CA, December 2, 1997 -- Maxim Pharmaceuticals (AMEX: MMP, SSE: MAXM) today announced publication in the current issue (Vol. 27, 5-6) of the journal Leukemia and Lymphoma of updated results of the Company's ongoing clinical trial. This trial, which utilized Maxim's lead cancer product Maxamine( in combination with Interleukin-2 (IL-2), significantly improved relapse-remission in acute myelogenous leukemia (AML) patients. Additionally, the Maxamine/IL-2 combination was well-tolerated, and did not demonstrate the severe side effects typically associated with high-dose IL-2 therapy alone.

"We continue to be encouraged by these clinical results that have demonstrated Maxamine Therapy's potential to prolong disease-free survival and maintain a quality of life in AML patients," said Larry Stambaugh, Chairman, President and CEO of Maxim. "We have shown that the Maxamine and IL-2 combination is safe and possibly effective as an outpatient therapy, leading us to prepare for the initiation of a Phase III trial in the United States, Europe and the Pacific Rim to begin in early 1998."

Mr. Stambaugh continued, "With these results, we now have positive efficacy data in two different cancers, AML and malignant melanoma. In malignant melanoma, we have demonstrated that Maxamine Therapy, in combination with IL-2 and/or Alpha Interferon (IFN-(), is a valid approach to treating cancers and shows promise in extending life. Phase I/II clinical trials in three other types of cancer and Hepatitis C are underway or planned."

Background on AML

AML is one of the most common adult leukemias. There are approximately 9,000 new cases and 7,000 deaths caused by AML each year in the United States alone. Patients are typically treated with chemotherapy to attain remission, yet 75-80 percent of these patients will relapse and may receive additional therapy. Historically, patients in their first remission (CRI) remain disease-free for an average of 12 months while patients who have relapsed and achieved a second or subsequent remission (CR2+) typically have shorter remissions averaging approximately six months or less. These relapsed patients have a hopeless (less than a 1 percent) probability of long-term survival.

Phase II Maxamine Results

Maxamine clinical results were reported in the paper titled, "Histamine and Interleukin-2 in Acute Myelogenous Leukemia" authored by Kristoffer Hellstrand, Ulf-Henrik Mellqvist, Elisabeth Wallhult, Jan Carneskog, Eva Kimby, Fredrick Celsing and Mats Brune. The trials are being conducted at several hospitals in Sweden.

The interim clinical data report was based on 22 patients with AML either in their first or subsequent remission. Each patient received Maxamine administered in combination with IL-2 in repeated courses of three weeks, continued until relapse or until a disease-free remission of 24 months was advised.

Of the 22 patients enrolled in the Maxamine Therapy trial, 13 patients were in CR1 and nine patients were in CR2+. Of the 13 patients in CR1, the reported mean remission time was 19 months (median 14) compared to the historical average of 12 months, and 70 percent were in complete remission. For the seven evaluable patients in CR2+, mean remission time was 19 months (median 21) compared to the historical average of six months, and 67 percent of the patients were in complete remission. Seven of the seven evaluable CR2+ patients had achieved a remission inversion, which is defined as prolonging the duration of complete remission to at least equal that of the patient's own previous remission. Remission inversion is important because subsequent remissions are usually increasingly shorter with current treatments and only approximately 10% of patients normally achieve remission inversion.

Updated Clinical Results

Since the time the above data were submitted for publication, the clinical study has continued to enroll and treat patients in Sweden. As of November 1, 1997, 29 patients were enrolled in the trial.

For the 18 patients treated in CR1, the mean time in remission is now 21 months (15 median) compared to the 12 month historical average. After 23 months of follow-up, 67 percent of the patients remain in complete remission, therefore the median time to relapse has not yet been reached.

For the 11 patients treated in CR2+, the mean time in remission is now 21 months (median 16) compared to the six month historical average. After 32 months of follow-up, the median time to relapse is 21 months and 36 percent remain in complete remission. 8 of 11 (73 percent) patients treated with Maxamine have achieved remission inversion.

"The results that we have seen in this clinical trial to date are substantial in terms of both remission times and percentage of patients with remission inversions, compared to other similar studies," said Kurt R. Gehlsen, Ph.D., Vice President, Development and Chief Technical Officer. "While these results are preliminary, we are especially encouraged by the remission inversion data. While other studies have reported around 10-20 percent remission inversion in patients, nearly three out of every four patients in our Phase II study have demonstrated remission inversion. This is extremely encouraging in a disease, such as AML, wherein once patients enter their second remission their long-term survival rate has historically been less than one percent."

Dr. Gehlsen continued, "These clinical data provide further evidence of the potential of Maxamine Therapy as a treatment that may significantly reduce the severe side effects associated with current cancer treatments. While chemotherapy and other treatments can be effective for a time, quality of life is of the utmost importance for cancer patients. The ability for patients to self-administer Maxamine Therapy in their own home, will be beneficial as we head toward the marketplace." Maxim and associated researchers will present their updated results on December 8, 1997 at the Annual American Society of Hematology Conference in San Diego, California.

Maxamine's mechanism of action

The scientific foundation for Maxamine Therapy is based on a discovery by the Company's scientists at the University of Gothenburg, Sweden. Their research may explain why, in part, cytokine therapy using IL-2 alone or IFN-( for certain cancers has demonstrated limited efficacy.

Maxim's research has shown that phagocytic cells may inhibit the tumor-killing activity of natural killer (NK) cells and T-cells, the body's natural defenses against cancer and infectious disease, by releasing reactive oxygen metabolites (ROMs). ROMs induce self-destruction (apoptosis) of NK-cells and T-cells, thus limiting the potential therapeutic effect of cytokines which activate NK-cells and T-cells to attack the tumor.

Maxim researchers have discovered that when Maxamine binds to the type 2 histamine receptor (H2 receptor) on the surface of phagocytic cells, it can, in effect, block the production of reactive oxygen metabolites (ROMs), and extend the life and potency of NK-cells and T-cells. Thus, when used in conjunction with cytokine therapy, Maxamine results in the preservation of NK and T-cell function, allowing cytokines to more fully elicit their anti-tumoral and anti-viral responses.

"Previous work has suggested that cytokine therapy should work," said Dr. Gehlsen. "However, the results to date without Maxamine have been disappointing. The discovery of the role of phagocytes and ROMs in the self-destruction of NK-cells and T-cells has allowed us to develop Maxamine Therapy, a unique approach to treating cancer by developing new treatments targeting a receptor that hasn't previously been utilized in the treatment of cancer."

Maxim Pharmaceuticals is developing novel therapeutics and vaccines for the prevention and treatment of cancer and infectious diseases. Maxim's focus is to develop novel products that include pharmacoeconomic and disease management benefits such as out-patient therapy, improved clinical efficacy, higher level of safety, lower treatment cost and improved patient compliance. The Company's secondary platform technology, MaxVax, now in preclinical development, utilizes a mucosal vaccine carrier/adjuvant system for a broad range of infectious disease. The Company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.

This news release contains forward-looking statements that involve risks and uncertainties. The company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include, but are not limited to, those discussed under "Risk Factors" and elsewhere in the company's on Form S-1 as filed with the Securities and Exchange Commission, including the uncertainties associated with product development, the risk that clinical trials will not commence when planned, the risks and uncertainties associated with dependence upon the actions of government regulatory agencies, and the risk that products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials.

Note: Maxamine, Maxamine Therapy, MaxVax and the Maxim logo are trademarks of the company.
Editor's Note: This release is also available on the Internet at:

Editor's Note: For an illustration of Maxamine's mechanism of action and technology backgrounder, please call Neil Cohen at (212) 696-4455 ext. 205 or Email:

Noonan/Russo Communications

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