Maxim Pharmaceuticals and Hoffmann -- La Roche Enter Into Significant Development Collaboration
SAN DIEGO--(BW HealthWire)--Aug. 10, 2000--

Maxim and Roche Expect Collaboration to Lead to Important Advances in the Treatment of Cancer and Hepatitis C

Maxim Pharma reported early study results at DDW and EASL, two recent science conferences held this past Spring. I don't think the study they conducted sorts out the potential benefits of Maxima. The study suggests a benefit but better designed studies are necessary to prove its benefit. The report can be read on the NATAP web site in either the EASL Conference Reports section or the DDW Reports.

Maxim Pharmaceuticals announced that it has entered into a comprehensive development collaboration with F. Hoffmann -- La Roche Ltd, Switzerland and its U.S. branch Hoffmann -- La Roche Inc. for the development of Maxim's lead drug Maxamine(R) (histamine dihydrochloride) in combination with the investigational compound Pegasys(R), Roche's pegylated interferon-alpha agent.

Both parties expect that the combination of Maxamine and Pegasys will lead to important advances in the treatment of cancer and hepatitis C.

"Roche clearly represents a great development partner for Maxim due to the success they have had with the clinical development of Pegasys, and the fact that they share our commitment to advancing the treatment of hepatitis C and cancer," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "This collaboration not only produces a substantial strategic and economic benefit to us, it allows us to accelerate and expand the clinical development of Maxamine."

"We are excited about the potential contribution that the combination of Maxamine and Pegasys may make to the treatment of hepatitis C and the targeted cancers," said Simon Pedder, Ph.D., Pharmaceutical Business Director for Pegasys. "Hepatitis C in particular is a substantial unmet need. Our hope is that the addition of Maxamine to Pegasys, an agent that has produced promising clinical data in hepatitis C as a monotherapy, will result in a combination therapy that represents a further improvement in patient care. In addition, the data from the Phase III trial of Maxamine in advanced malignant melanoma encouraged us to move aggressively forward with the development of the Pegasys/Maxamine combination treatment in cancer."

Under the agreement, Maxim and Roche will undertake clinical trials and other activities designed to seek regulatory approval of the combination of Maxamine and Pegasys for the treatment of hepatitis C and certain cancers. Specifically, the collaboration program will include two Phase III trials of the Maxamine and Pegasys combination for the treatment of hepatitis C, one Phase III trial of Maxamine and Pegasys for the treatment of advanced-stage renal cell carcinoma, and an additional Phase III trial in another cancer to be selected by the two companies.

Roche will perform the management, monitoring and data management of the trials at its own cost and Roche and Maxim will share equally the third party costs of the trials. Each company will retain marketing responsibilities and revenues for their respective drugs, although under the collaboration agreement they will cooperate in the training of their respective sales forces.

The U.S. Phase III trial of Maxamine for the treatment of malignant melanoma was completed in March 2000 and the related New Drug Application was filed by Maxim with the U.S. Food and Drug Administration in July 2000. In addition, interim 24-week results from a Phase II dose-ranging hepatitis C study showed that the combination of the optimal dosing regimen of Maxamine and interferon-alpha achieved a complete viral response in 69 percent of all patients, compared to the 29 percent or less response that is commonly observed in patients treated with interferon-alpha alone.

Maxamine Mode of Action

 Research suggests that a universal mechanism in the human body suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in 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 these diseases. Maxamine protects critical immune cells and is administered in combination with stimulators of these same immune cells (cytokines such as interferon-alpha and IL-2). More than 1,200 patients have been treated in the Maxim's completed and ongoing clinical trials.

In addition to the U.S. Phase III trial for the treatment of malignant melanoma completed in March 2000, Maxamine is currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is an investigational drug and safety and efficacy have not been established at this time. However, 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.