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Maxamine Treatment Results in Brain Cancer Reduction in Research Model; Preclinical Results Demonstrate Potential Benefit of Maxamine and IL-2 in Malignant Glioma.


SAN DIEGO--(BW HealthWire)--Oct. 19, 1999--

Maxim Pharmaceuticals (AMEX AMEX

See: American Stock Exchange
:MMP MMP Matrix Metalloproteinase (enzymes related to tissue healing/remodeling and cancer cell metastasis)
MMP Mixed Member Proportional (New Zealand electoral system)
MMP Multi-man Publishing
), (SSE (1) An earlier full-screen editor in OS/2.

(2) (Streaming SIMD Extensions) A series of additional instructions built into Pentium CPU chips for improved multimedia performance by performing mathematical operations on multiple sets of data at the
:MAXM) today announced that combination therapy with Maxamine(R) (histamine) and interleukin-2 (IL-2) resulted in a significant reduction of the growth of established brain cancer (malignant glioma glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. ) in rats.

The studies were reported in the "Journal of Neuro-Oncology" (volume 39, issue 2, p. 99-196, abstract no. 125), and presented at the annual EANO (European Association of Neuro-Oncology) meeting by a team of researchers from the Department of Neuro-Oncology and Oncology at the University of Umea in Sweden. The title of the presentation is "Histamine and Interleukin-2 Inhibit Growth and Neovascularisation in Malignant Glioma."

The research team at the University of Umea studied the effects of Maxamine in a rat model for brain cancer. In this model, a fast-growing malignant glioma (BT4C) is transplanted into the brain of rats. After a period during which the tumors were allowed to grow without treatment, the animals were treated with Maxamine, IL-2 or the combination of Maxamine and IL-2. The size of brain tumors was measured after approximately two weeks of treatment.

The results showed that a statistically significant reduction of brain tumor volume was observed in animals treated with the combination of Maxamine and IL-2. Monotherapy with IL-2 alone did not significantly reduce tumor growth.

"Intra-cerebral cancers are difficult to treat, and it is encouraging that treatment with Maxamine and IL-2 significantly reduced the growth and the number of new blood vessels Blood vessels

Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names.
 formed in this fast-growing tumor," said Kurt R. Gehlsen, Ph.D., Maxim's vice president, development and chief technical officer. "It remains to be established whether the combination of Maxamine and IL-2 is also effective in humans with malignant glioma, but this disease is a strong candidate in the further clinical development of Maxamine Therapy."

The American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
 estimates that 17,500 Americans develop primary brain cancer each year. Malignant glioma is the most common form of primary brain cancer, and one of the most rapidly progressive and fatal of all cancers. Patients with malignant glioma may undergo surgical removal of the tumor, but the disease has a high recurrence rate, and there is a high need for improved therapy.

Overview of Maxamine Therapy

In many patients with cancer and chronic infectious diseases, the capacity of the patient's immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 to detect and destroy tumor cells or virally infected cells is compromised. Cytokines Cytokines
Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors.
, a class of naturally occurring proteins, are potent stimulators of certain key immune cells. Cytokines such as IL-2 and interferon-alpha have been approved for the treatment of certain cancers and infectious diseases, but when used as single-agent therapies they are ineffective in the majority of patients and cause severe toxic side effects Side effects

Effects of a proposed project on other parts of the firm.
.

Maxamine Therapy combines the administration of Maxamine, a drug that protects critical immune cells, with the administration of cytokines and other agents that stimulate these cells. This combination of actions is designed to improve the immune system's ability to identify, disable and destroy malignant or infected cells.

In addition to extending survival, maintaining the quality of a patient's life during treatment is an important objective of Maxamine Therapy. Many current treatments for cancer and some infectious diseases are as harsh as the illnesses themselves, forcing patients to make the difficult choice of whether to continue therapy. Maxamine can be safely self-administered by patients in their own homes.

Company Overview

Maxim Pharmaceuticals is developing advanced drugs, therapies and vaccines for cancer and infectious diseases. The company's lead drug candidate, Maxamine, is currently being tested in three Phase III cancer clinical trials in 14 countries around the world for malignant melanoma Malignant Melanoma Definition

Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin.
 and acute myelogenous leukemia acute myelogenous leukemia
n. Abbr. AML
Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms.
. Maxim expects to file its NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  and report results for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in mid 2000.

Phase II trials of Maxamine Therapy are also underway for the treatment of hepatitis C Hepatitis C Definition

Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild.
 patients and advanced renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
 patients. Maxamine is designed to be safely self-administered by patients in their own homes, and more than 800 patients have been treated in our completed and ongoing clinical trials.

The company is also developing MaxDerm(TM), a Maxamine-related drug for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers Decubitus ulcers
A pressure sore resulting from ulceration of the skin occurring in persons confined to bed for long periods of time

Mentioned in: Immobilization
, shingles, burns and related conditions. The company's third platform technology, MaxVax(TM), now in preclinical development, utilizes a needle-free 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. Such forward-looking statements include statements regarding the efficacy and intended utilization of Maxamine and 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 efficacy in larger-scale clinical trials and the risk that the company will not obtain approval to market its products. These factors and others are more fully discussed under "Risk Factors" and elsewhere in the company's Annual Report on Form 10-K/A for the year ended Sept. 30, 1998 and the company's Registration Statement on Form S-3 (File No. 333-84711), as filed with the Securities and Exchange Commission.

Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), MaxVax(TM), and the Maxim logo are trademarks of the company.

Editor's Note: This release is also available on the Internet at: http://www.maxim.com.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Oct 19, 1999
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