Maxim Announces Initiation of Enrollment in Oral Mucositis Clinical Study
SAN DIEGO--(BW HealthWire)--Aug. 19, 2002--Maxim Pharmaceuticals Inc. (Nasdaq:MAXM - News; SSE:MAXM) announced the commencement of a randomized, blinded clinical study of its MX8899 topical gel for the treatment of oral mucositis, a common, painful and debilitating toxicity suffered by cancer patients treated with certain chemotherapeutic agents and radiation therapy.
Symptoms of oral mucositis include the formation of canker sore-like lesions within the mouth that may extend to the tongue, throat and gastrointestinal tract, with mild to severe discomfort and difficulty eating and drinking. The lesions may last two to three weeks, and in severe cases patients require hospitalization, pain medication, and limitations or interruptions in their cancer therapy. Currently, there is no effective therapy for the prevention or treatment of oral mucositis.
"A product that would assist patients with this painful and debilitating condition fits well with our company's mission of maintaining the quality of patients' lives during therapy, and would fit strategically with our proposed commercialization plans for Ceplene(TM) in oncology," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "Oral mucositis is a large unmet medical need and represents a substantial commercial market. The oral mucositis trial complements the study we plan to commence this year for the treatment of radiation dermatitis, another debilitating side effect of radiation cancer therapy."
The clinical study is being conducted by Prof. Jacob Rowe, Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, and Dr. Reuven Or, Department of Bone Marrow Transplantation, Hadassah Ein-Karem Medical Center, both in Israel. Up to 60 patients will be enrolled in the trial, each of whom is to receive chemotherapy with or without total body irradiation in preparation for either allogeneic or autologous hematopoietic stem cell transplantation.
Half of the patients in the study will be randomized to receive the topical gel, the other half will receive a placebo control gel. The study will be blinded as the investigator and the patient will be unaware of whether the patient is receiving the investigational drug or the placebo. The treatment will start on the same day as the induction of chemotherapy or radiation and will continue for up to 28 days. The objectives of this study are to evaluate the safety, tolerability, and biological activity of the topical gel for the treatment of oral mucositis. Efficacy will be measured by the assessment of severity of oral mucositis as measured through two validated scoring scales that assess oral pain, swallowing and function as well as degree of ulceration and erythema in the oral cavity.
Overview of Topical Gel
Histamine dihydrochloride, the active agent in the gel, has been shown in preclinical work to reduce inflammation by preventing the production and release of oxygen free radicals and proinflammatory cytokines such TNF-alpha and IL-1b, thereby reducing oxidative stress. In addition, it has been reported that histamine will improve blood circulation and assist in wound healing. Accordingly, histamine-related gels have the potential to be useful in situations where free-radical damage and excessive inflammation are involved, and to facilitate the repair processes.
Maxim's topical gel has been tested by investigators in small pilot, randomized, blinded, placebo-controlled trials conducted by independent researchers in more than 75 patients with oral mucositis, herpes labialis (cold sores), burns (thermal and sun), decubitus ulcers, shingles and conjunctivitis. Patients experienced improved healing times when treated with topical histamine gels compared to placebo controls. Additional investigator clinical studies of the histamine gel are planned for 2002 in radiation dermatitis (a serious side effect of certain radiation therapy) and aphthous stomatitis (canker sores). The intellectual property protection surrounding Maxim's topical gel technology includes seven U.S. patents and one pending U.S. patent application, with corresponding patents issued or pending in major international markets. The topical histamine gel is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
Maxim's lead drug Ceplene(TM), based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. Ceplene is currently being tested in Phase 3 cancer clinical trials for advanced metastatic melanoma and acute myelogenous leukemia. Phase 2 trials of Ceplene are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. More than 1,400 patients have participated in the company's completed and ongoing clinical trials. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency. Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases.
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 Ceplene, the apoptosis modulator technology and MaxDerm, and regarding 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 safety or efficacy in larger-scale clinical trials, the risk that the company will not obtain approval to market its products, and the risk that clinical trials may not commence when planned. These factors and others are more fully discussed in the company's periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the company.
Editor's Note: This release is also available on the Internet at maxim.com.
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Contact:
Maxim Pharmaceuticals Inc.
Larry G. Stambaugh, 858/453-4040
or
Burns McClellan
John Nugent, 212/213-0006 (Investors)
or
Coffin Communications Group
Sean Collins / Valerie Bent (Media)
818/789-0100 |
