Human Genome Sciences, Inc. (HGSI) has announced 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.
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."
The company release states that individuals interested in Repifermin are encouraged to contact Human Genome Sciences at 301/610-5790, extension 3550, or via the Internet at www.hgsi.com.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients.