Friday evening conference call, as noted on Valuation and Short Candidate threads, indicated this would happen.
>>ROCKVILLE, Md., Dec. 7 /PRNewswire/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - news) announced today that the results of two Phase 2a clinical trials demonstrate the safety of systemically administered repifermin. Both studies were designed to evaluate safety, dosing schedules and preliminary efficacy. The primary endpoint for both studies was safety.
Results of a Phase 2a clinical trial evaluating repifermin (keratinocyte growth factor-2, KGF-2) as a treatment for cancer therapy-induced mucositis were reported today during a symposium prior to the American Society of Hematology annual meeting in Orlando, Florida.
The double-blind, placebo-controlled, dose-escalation Phase 2a human clinical study of repifermin was designed to determine repifermin's safety, dosing schedule, and preliminary efficacy. It was conducted in ninety-one patients who underwent high-dose chemotherapeutic conditioning regimens, with or without total body irradiation, for autologous hematopoietic stem cell transplantation. In the study, repifermin was administered intravenously daily for fourteen days following transplantation. Results showed that repifermin was well tolerated with no discernable differences from placebo in adverse events or laboratory abnormalities. No evidence that repifermin administered following transplantation was active in reducing the incidence or severity of mucositis was shown in this study.
David C. Stump, M.D., Senior Vice President, Drug Development, Human Genome Sciences, said, ``We are pleased to see mounting evidence of repifermin's excellent safety profile. Efficacy data in this trial were difficult to interpret because of the small number of patients, the high degree of variability in tumor types and conditioning regimens, and a lower than expected percentage of placebo-treated patients with severe mucositis. More importantly, the study evaluated repifermin in a dosing schedule that we no longer believe is optimal. The addition of dosing prior to the conditioning regimen is strongly supported by preclinical studies, several of which are included in a poster presentation reported here at the American Society of Hematology meeting.(1) We have been enrolling an additional forty- two subjects under an amended protocol to examine the safety and preliminary activity of repifermin administered both prior to the conditioning regimen and following the autologous hematopoietic stem cell transplantation.''
Dr. Stump noted that a separate Phase 2a clinical trial is also underway to investigate a pre- and post- dosing schedule of repifermin for treatment of mucositis in patients undergoing chemotherapy for multiple myeloma prior to autologous hematopoietic stem cell transplantation.(2)
Mark M. Schubert, D.D.S., M.S.D., Professor of Oral Medicine, Fred Hutchinson Cancer Center, Seattle, said, ``Mucositis is a frequent complication in patients undergoing cancer therapy. It can be a dose-limiting side effect. Patients with severe mucositis may require prolonged hospitalization to enable them to receive adequate nutrition and pain medication. They are at increased risk of serious infection. We believe that repifermin has promise as a treatment for mucositis. Data have become available since the trial was initiated, showing that pretreatment with repifermin is protective in four animal models. In a patient population similar to the population studied in the current trial, another member of the fibroblast growth factor family reduced the duration of severe mucositis when administered prior to the chemotherapeutic conditioning regimen. We therefore conclude that continued evaluation of repifermin is warranted with administration prior to and after the conditioning regimen.''
Human Genome Sciences also announced today the results of a Phase 2a study of repifermin in treatment of patients with ulcerative colitis, the most common form of inflammatory bowel disease (IBD). The double-blind, placebo- controlled, dose-escalation trial was designed to determine repifermin's safety, dosing schedule, and preliminary efficacy. It was conducted in eighty-eight patients with active ulcerative colitis. In the study, repifermin was administered intravenously daily for five days. Results showed that repifermin was well tolerated with no discernable differences from placebo in adverse events or laboratory abnormalities. No evidence that repifermin was effective at the doses and schedule examined in treating patients with active ulcerative colitis was shown in this study. Results of the ulcerative colitis study will be submitted for presentation to an upcoming medical meeting.
William J. Sandborn, M.D., Professor, Mayo Medical School, Director of IBD Research at the Mayo Clinic, and a member of the ulcerative colitis study steering committee, said, ``Ulcerative colitis is a disease with devastating impact on patients' daily lives. A great need exists for new treatment approaches. Although the current study did not yield evidence of efficacy, the results do reveal that repifermin is well tolerated in these patients at all doses studied in this trial. Since the maximally tolerated dose was not reached in the current study, we believe that additional study to evaluate safety and preliminary activity at higher doses is warranted.''
Dr. Stump said, ``We are gratified by the additional data emerging from the ulcerative colitis trial confirming that repifermin is safe. We will fully analyze the final results, consult with our clinical investigators and the FDA, then decide on how best to proceed with repifermin in this indication.''
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer of Human Genome Sciences, said, ``We continue to move forward with our clinical program for repifermin to evaluate its potential in treating venous ulcers and internal wounds of the mucous membranes that line the mouth and gastrointestinal tract. We are particularly pleased with the strong clinical evidence of repifermin's safety, and with results to date of clinical trials in chronic venous ulcer patients. The Phase 2a results demonstrated that repifermin accelerates healing of chronic venous ulcers with an excellent safety profile.(3),(4) Repifermin is now the subject of an ongoing large- scale Phase 2b clinical trial to investigate its use as a topical wound healing treatment for chronic venous ulcers.(5)''
Repifermin is a novel human protein, discovered by Human Genome Sciences, that stimulates proliferation, differentiation and migration of epithelial cells. Human Genome Sciences selected repifermin for development as a drug because of its potential to promote healing of skin wounds and internal wounds of the mucous membranes that line the gastrointestinal tract. For more information on repifermin, see hgsi.com .<<
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Wouldn't surprise me if HGSI gets overpunished in the context of a possible market correction. Those productivity and jobs figures didn't look too good, and consumer sentiment seems to be a lagging emotional indicator these days, pretty volatile. And that might present an excellent buying op, so staying tuned.
Cheers, Tuck |
