TORONTO, Oct. 31, 2000 — Hemosol Inc. (TSE:HML) announced on October 17 that it has been granted regulatory approval for the Investigational New Drug (IND) submission for its cell therapy program to treat chronic myeloid leukemia (CML).

This Phase I study, titled "Autologous gamma-delta T Cell Infusion After Intensive Therapy and Autotransplant for Advanced Ph(+) Chronic Myeloid Leukemia," will investigate the feasibility of expanding gamma-delta T cells from patients with advanced CML for the purpose of re-infusion of the cells as a treatment for residual disease. The principal investigator of the study is Dr. Armand Keating of the Princess Margaret Hospital in Toronto, Ontario.

"Initiation of this trial is a potentially important event for patients suffering from CML, as well as an important event in the development of our broad product pipeline."

"Initiation of this trial is a potentially important event for patients suffering from CML, as well as an important event in the development of our broad product pipeline," said Dr. David Bell, Vice President of Scientific Affairs at Hemosol. "HML-115 is our second product, after Hemolink(TM), to enter clinical trials. As the HML-115 therapeutic strategy is applicable to numerous other cancers, CML will serve as a model to establish the safety and efficacy of this potentially powerful therapeutic tool."

The trial will include up to fifteen patients with chronic phase or accelerated phase CML who are ineligible for interferon therapy or who lack a suitable bone marrow transplant donor. The patients will undergo three steps in the HML-115 therapy. First, peripheral blood cells will be collected from the patient and enriched and expanded to yield large numbers of cytotoxic immune cells, gamma-delta T cells. Second, the patients will be given a standard chemotherapy and progenitor cell transplant therapy using their own (autologous) cells or bone marrow. Finally, the patient will be given back their own expanded cytotoxic gamma-delta T cells to help eradicate any residual tumour cells.

CML is a malignancy which accounts for 20 percent of all leukemias, with an annual incidence of one per 100,000 population. While treatment options have improved over the last ten years, further advances are still needed. More information about CML is detailed on Hemosol's website.

Hemosol's cell therapy consists of cells expanded outside the body in Hemosol's proprietary defined culture medium. The program is focused on the use of gamma-delta T cells for treating chronic myeloid leukaemia as a model for other cancers. Despite recent improvements in cancer management, many patients are not cured due to residual cells that may be resistant to chemotherapy. Expanded numbers of gamma-delta T cells provided by Hemosol's cell therapy may provide a powerful therapeutic tool to control or eradicate these residual cancer cells.

Hemosol's Product Pipeline

Hemosol Inc. has a broad range of products in development which include; Hemoglobin based oxygen carriers(HbOCs); hemoglobin therapeutics to treat a variety of disease such as reperfusion injury, hepatitis C and cancers of the liver; and cell therapy for the treatment of cancer and infectious disease. The company is also developing methods to harvest hemoglobin, from cells grown and expanded under controlled manufacturing conditions outside of the human body.

About Hemolink

Hemolink(TM) is a highly purified human-derived hemoglobin replacement product manufactured through a series of proprietary processes. Potential benefits of Hemolink(TM) include greater assurance of safety from viral and bacterial contamination and universal compatibility with all blood types. Hemolink(TM) also provides efficient oxygen delivery to vital organs and tissues; a reduced risk of allergic or immune reaction; and an extended shelf life of more than one year compared with 42 days for donor blood. The company anticipates that these potential benefits will provide the medical community and the public with new ways to avoid or reduce patient exposure to donor blood, and to reduce the complications related to untreated acute haemoglobin deficiency.

Hemolink(TM) has now been submitted for regulatory approval in Canada and a pivotal U.S. Phase III study is currently underway with results expected in the second quarter of 2001.

About Hemosol Inc.

Hemosol is an integrated biopharmaceutical company developing a multi- product pipeline for global markets based on proprietary technologies for use initially in the treatment of hemoglobin deficiencies.

Source: Hemosol Inc.

Give me a holler

CMLSupport Home Page

This site was last updated on Nov. 8, 2000

Copyright © 2000 CMLSupport.com
These contents may not be reproduced in whole or in part without the express written permission of the author, or she will beat you up and stuff.