Tuesday September 4, 4:10 pm Eastern Time
Press Release
Repifermin Trials for Treatment of Cancer Therapy Induced
SOURCE: Human Genome Sciences, Inc.
Human Genome Sciences Initiates New Clinical Trial For Treatment of Mucositis In Multiple Myeloma Patients
- Repifermin Trials for Treatment of Cancer Therapy Induced Mucositis Are Extended to Additional Patient Group -
ROCKVILLE, Md., Sept. 4 /PRNewswire/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - news) announced today that the company has initiated a Phase 2 clinical trial to examine the safety and preliminary efficacy of repifermin for the treatment of mucositis in patients undergoing chemotherapy for multiple myeloma prior to autologous hematopoietic stem cell transplantation. Repifermin is also undergoing Phase 2 trials for evaluation of safety and preliminary efficacy for treatment of mucositis in patients under other cancer therapy regimes. Preliminary results from the first Phase 2 trial are expected later this year.
(Photo: newscom.com )
David C. Stump, M.D., Senior Vice President, Drug Development, Human Genome Sciences, said, ``Based on our preclinical and early clinical data we are excited about the possible role that repifermin may have in the treatment of mucositis in the multiple myeloma patient population. We think this drug may have great potential for treatment of a variety of different types of injury to epithelial tissues.''
Elias J. Anaissie, M.D., lead investigator for the trial, Professor of Medicine and Director of Supportive Care, Myeloma and Transplantation Research Center, University of Arkansas for Medical Sciences, Little Rock, said, ``Severe mucositis may require prolonged hospitalization to enable patients to receive sufficient nutrition and narcotic pain medication. Patients with this condition are also at risk of serious and potentially fatal infections. We are pleased to have the opportunity to evaluate a promising new therapy with the potential to play a major role in treating mucositis.'' Mucositis is a systemic condition manifested by inflammation and ulceration of the lining of the mouth, throat or gastrointestinal tract, and is most commonly associated with chemotherapy or radiotherapy for cancer.
The new trial is a double-blind, dose-escalation, crossover study. It is designed to evaluate the safety and optimal dosing schedule for use of repifermin for mucositis in multiple myeloma patients receiving high-dose chemotherapy prior to autologous hematopoietic stem cell transplantation. The trial will enroll 80 patients, who will be randomized to receive the drug or a placebo both prior to their chemotherapeutic conditioning regimen and after their autologous hematopoietic stem cell transplant.
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer of Human Genome Sciences, Inc. said, ``Initiation of this new trial is a measure of our confidence in the potential efficacy of repifermin for the treatment of a variety of diseases of epidermal tissues including the treatment of ulcerative colitis, venous ulcers and cancer therapy induced mucositis. Our company continues to focus on bringing new human protein and antibody drugs to patients to address previously unmet medical needs.''
Individuals interested in Repifermin are encouraged to contact Human Genome Sciences at 301-610-5790, extension 3550, or via the Internet at hgsi.com .
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients.
HGS and Human Genome Sciences are registered trademarks of Human Genome Sciences, Inc. For additional information on Human Genome Sciences, Inc., visit the company's web site at hgsi.com . Copies of HGS press releases are also available by fax 24 hours a day at no charge by calling 800-758-5804, ext. 121115.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the company's unproven business model, dependence on new technologies, uncertainty and timing of clinical trials, ability to develop and commercialize products, dependence on collaborators for services and revenue, substantial indebtedness, intense competition, uncertainty of patent and intellectual property protection, dependence on key management, uncertainty of regulation of products, dependence on key suppliers, the impact of future alliances or transactions and other risks that may be described in the company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
SOURCE: Human Genome Sciences, Inc. |
