Clinical Results Will Be Presented Today at 1998 American Society of Hematology (ASH) Conference
San Diego, CA, December 7, 1998 - Maxim Pharmaceuticals (AMEX: MMP, SSE: MAXM) announced updated results from an ongoing Phase II clinical trial of its lead drug Maxamine® in patients with acute myelogenous leukemia (AML). The results from the trial suggest encouraging increases in leukemia-free survival in AML patients treated in remission with Maxamine Therapy.
The updated results will be presented today by Mats Brune, M.D., and Elisabeth Wallhult, R.N., Department of Hematology, Sahlgrenska University Hospital, Gothenburg, Sweden, at the American Society of Hematology Conference in Miami, Florida. "We are very pleased with the number of patients that remain in leukemia-free remission," said Dr. Brune.
The strength of the Phase II data led Maxim to commence a Phase III clinical trial of Maxamine as a remission therapy for AML patients. The Phase III trial, which began earlier this year, is underway in 11 countries and more than 100 clinical sites around the world. "The number of clinical sites that have approached Maxim and agreed to participate in this trial has greatly exceeded our expectations," said Dr. Kurt Gehlsen, chief technical officer of Maxim. "We believe that this interest results from the promising data we have seen in the Phase II trial for this population of patients who have limited options for therapy today."
Background on AML
AML is the most common form of acute leukemia in adults, and prospects for long-term survival are poor for the majority of patients. There are approximately 20,000 new cases and 15,000 deaths caused by AML each year in the United States, Europe and Australia.
Once diagnosed with AML, patients are typically treated with chemotherapy, and the majority achieve complete remission ("CR"). Unfortunately 75-80% of patients who achieve their first CR ("CR1") will relapse, and the median time in remission before relapse is only 12 months with current treatments.
Relapsed patients are typically treated again with chemotherapy, and many of these patients die during chemotherapy. Among those relapsed patients who do survive treatment and achieve a second complete remission ("CR2"), these subsequent remissions normally have a shorter duration than the prior CR (a median of only 6 months in the case of CR2 patients).
The objective of Maxamine Therapy is to treat AML patients in remission with the combination of Maxamine and low doses of interleukin-2 (IL-2) to prevent relapse and prolong leukemia-free survival while maintaining a good quality of life for the patients during treatment.
Maxamine Improvement in Leukemia-Free Survival
In the ongoing Phase II study, patients treated in their first remission with Maxamine Therapy have experienced a substantial increase in leukemia-free survival, highlighted by the following updated clinical results as of September 1, 1998:
58% (15 of 26) of all CR1 patients treated with Maxamine remained in leukemia-free remission. A prior study (Swansbury, et. al.) of AML patients suggest that 20-25% of patients would be expected to be alive after two years.
65% (13 of 20) AML patients without concurrent disease or antecedent illnesses treated with Maxamine remain in leukemia-free remission.
After a median of 24 months of follow up, the median time to relapse has not been reached in this study as more than 50% of the Maxamine-treated CR1 patients remain leukemia-free. By contrast, under the normal course for AML, the median time to relapse would be expected to be reached after only 12 months.
These results were achieved despite the fact that the patients treated with Maxamine were an older group of patients and more than half (15 of 26) of the patients were categorized as high risk.
"The updated results are very promising," said Dr. Bengt Simonsson, Head of the Division of Haematology, University Hospital, Uppsala. "In past randomized studies using either IL-2 alone or similar agents we have not seen evidence of significant benefit to the patients. The Maxamine results suggest the potential for a meaningful advancement in the care of AML patients."
Patients treated in their second or subsequent remission ("CR2+") historically have a poor prognosis with about 5% achieving long-term survival. The 13 CR2+ patients treated with Maxamine Therapy in the ongoing Phase II study have experienced a substantial increase in remission duration, highlighted by the following results updated as of September 1, 1998:
The median time to relapse for the CR2+ patients was 21 months, more than three times the six-month historic median.
Only 10-20% of AML patients under the current standard of care historically achieve remission inversions, the lengthening of subsequent remission times beyond the duration of their previous remissions. However, 8 of 11 (73%) of the evaluable CR2+ patients treated with Maxamine Therapy have achieved remission inversion.
Moreover, 38% of the CR2+ patients treated with Maxamine Therapy remain in leukemia-free remission.
Quality of Life during Maxamine Therapy
In the Phase II study, patients have administered more than 8,000 doses of Maxamine at home. No unexpected side effects from the drug have been identified during the study. The majority, 75%, of the evaluable patients have returned to work while taking Maxamine Therapy. The study results suggest that the administration of Maxamine Therapy at home as a remission therapy for AML is both safe and feasible.
"Quality of life is very important for AML patients during remission," said Dr. Brune. "The ability to provide remission therapy on an outpatient, at-home, basis is essential to allow the patients to maintain as closely as possible their normal lifestyle."
Maxamine Mechanism of Action
In many patients with chronic infectious diseases and cancer, the capacity of the patient's immune system to detect and destroy diseased cells is compromised. Maxamine Therapy combines the administration of Maxamine, which protects critical immune cells, with the administration of cytokines such as interferons or IL-2, which stimulate these immune cells.
Maxim scientists have shown that the suppressive effect of the phagocytes, a class of white blood cells, is an important mechanism that prevents the immune system from effectively fighting cancer. Phagocytes release free-radicals that induce T-cells and NK-cells, immune cells that are critical in the fight against cancer and infectious diseases, into programmed cell death or apoptosis. Cytokines, such as IL-2 and interferon-a and vaccines are potent stimulators of T-cells and NK-cells, yet they are often rendered ineffective as therapeutics due to phagocyte-derived free-radical induction of programmed cell death of the critical immune cells. Maxamine has been shown to clearly and effectively prevent the production and release of phagocyte-derived free radicals, thereby protecting T-cells and NK-cells and enhancing the immune stimulating capabilities of certain cytokines and other immunotherapies.
Complementing the AML results described above, Phase II clinical studies of Maxamine Therapy in advanced malignant melanoma have shown a more than doubling in survival outcomes and the maintenance of patient quality of life during treatment. Earlier-stage clinical studies have also suggested promise in renal cell carcinoma and hepatitis. "The growing body of human data in several cancers and viral infections is leading Maxim into a clinical development program that focuses Maxamine as an immuno-modulator that may be used broadly to improve cytokine therapy, cancer vaccines and other stimulators of the immune system," stated Larry Stambaugh, chairman and chief executive officer of Maxim.
Maxim Pharmaceuticals, Inc.
Maxim Pharmaceuticals is developing advanced drugs and vaccines for 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, cost-effective treatment and improved patient compliance. The Company has initiated three Phase III cancer clinical trials for its lead product Maxamine in the U.S., Europe and Australia for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine Therapy are ongoing or planned for other cancer indications such as renal cell carcinoma and prostate adenocarcinoma. The Company also plans to test Maxamine Therapy in a Phase II clinical trial for the treatment of hepatitis C patients. The Company's secondary platform technology, MaxVax®, now in preclinical development, utilizes a 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. 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 Annual Report on Form 10-K for the year ended September 30, 1997 and the Company's Registration Statement on Form S-3 (File No. 333-65011), each as amended through the date hereof, as filed with the Securities and Exchange Commission, including the uncertainties associated with patent protection, the risk that products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that clinical trials will not commence when planned, and the risk that the Company will not obtain approval to market its products.
Note: Maxamine®, Maxamine Therapy®, MaxVax®, and the Maxim logo are trademarks of the Company.
Contact: Larry G. Stambaugh
Chairman, President & CEO or
Dale A. Sander
Chief Financial Officer
Maxim Pharmaceuticals
(619) 453-4040
Noonan/Russo
Amy Flood (media),
(415) 677-4455 ext. 211
John-Kenneth Billingsley (investors),
(212) 696-4455 ext. 232