Preclinical news, updates, chatter about enrollment, all will continue. Meant results from finished clinical trials when I said "clinical news" in the last post. Because, of course, there will be plenty of stuff like this:
>>ROCKVILLE, Md., Dec. 9 /PRNewswire/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - news) announced today the results of three preclinical studies, which were presented this weekend at the annual meeting of the American Society of Hematology in Orlando.
Data were presented on three of Human Genome Sciences' products in clinical and preclinical development during the Saturday, December 8 and Sunday, December 9 sessions.
In a study entitled Long-Term Repopulating Bone Marrow Hematopoietic Stem Cells Are Protected In Vivo From 5-Fluorouracil (5-FU) Induced Cytotoxicity By a Novel B-Chemokine: Mirostipen (CkB-8, MPIF-1), investigators from Human Genome Sciences provided data on the in vivo effect of mirostipen on the recovery of hematopoietic stem cells with long-term repopulating potential following 5-fluorouracil (5-FU) treatment in animal models. Results demonstrate for the first time that both the myeloid and lymphoid lineages, both T- and B-cells, were protected, and thus, efficiently reconstituted, in mirostipen-treated animals. Investigators concluded that mirostipen does exhibit a positive effect on the protection of long-term repopulating bone marrow hematopoietic stem cells, and support the continued development of mirostipen as a potential treatment for accelerating recovery from chemotherapy-induced myelotoxicity. (Abstract #1250)
A second poster presentation on Sunday entitled Biodistribution of Radiolabeled BLyS Protein in Mice Demonstrates Rapid and Specific Targeting to Lymphoid Tissues and B-Cell Tumors provides a scientific rationale for developing a radiolabeled BLyS(TM) (B lymphocyte stimulator) treatment for certain B cell cancers. BLyS is a naturally occurring protein that specifically binds to and regulates the development of B lymphocyte cells. BLyS labeled with iodine-125 (125I) showed specific localization to spleen, lymph nodes, and lymphoid tissue following intravenous injection in normal mice and mice bearing B-cell tumors. In addition, radiolabeled BLyS targeted tumors in animal models of non-Hodgkin's lymphoma and multiple myeloma. Overall, these results demonstrate rapid and specific targeting to lymphoid tissues and B-cell tumors with administration of a radiolabeled BLyS, and support the further evaluation of a radiolabeled BLyS protein to treat B cell cancers, such as non-Hodgkin's lymphoma and multiple myeloma. (Abstract #1588)
During Saturday's session, Human Genome Sciences showed results on the Activity of Repifermin Administered Prophylactically in Mucositis and Other Models of Experimental Injury: Support for clinical use of keratinocyte growth factor -2 in a pretreatment regimen. Data demonstrate that repifermin pretreatment was protective in studies involving radiation-induced mortality in mice, cyclophosphamide-induced mucositis in the bladders of rats, indomethacin-induced intestinal mucositis in rats and LPS-induced endotoxemia in mice. The protective effect observed provides strong rationale for implementing a prophylactic regimen in ongoing repifermin clinical trials, which are evaluating the drug's potential to treat cancer therapy-induced mucositis. (Abstract #806)
Human Genome Sciences is currently conducting a Phase 2 clinical program to evaluate repifermin as a treatment for cancer-therapy-induced mucositis. The company announced on Friday that it has expanded its existing Phase 2a trial to include a pretreatment regimen. Mirostipen is also under evaluation in a Phase 2 clinical program as a potential treatment for cancer therapy- induced neutropenia, and recently announced that two Phase 2 clinical trials had completed enrollment. Human Genome Sciences continues to investigate the potential of a radiolabeled BLyS protein therapeutic for certain B cell cancers, and plans to initiate a clinical program when appropriate.
David C. Stump, M.D., Senior Vice President, Drug Development, Human Genome Sciences, said, ``We are extremely pleased with the progress to date in our pursuit of new product development opportunities, which will lead to expansion of our existing clinical programs. The mirostipen data presented at this year's meeting provide the first scientific evidence that treatment with mirostipen may provide stem cell protection to both B cell and T cell lineages. We look forward to the Phase 2 clinical trial results as a start to better understanding of mirostipen's potential. The repifermin data have provided scientific support for the Phase 2 mucositis clinical program to expand to include a pre- and post-treatment regimen to evaluate repifermin's potential prophylactic benefit.''
``In addition to the data at this year's meeting that support our hematologic products in clinical development,'' Dr. Stump continued, ``we have presented initial data on what we hope will be one of our promising future products, a radiolabeled BLyS protein, which combines the specificity of BLyS with the therapeutic effect of a radioisotope to target and kill cancer cells. Further preclinical evaluation is underway.''
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, Human Genome Sciences, commented, ``Our achievements to date with our preclinical and clinical programs are a testament to our approach to the discovery and development of gene-based drugs to help treat and cure diseases. We look forward to introducing new products into our clinical pipeline and continuing to explore other applications for our existing products.''
snip regarding my emphasized section: "Very true, Mr. Haseltine. Just how big are those achievements, though?" Spin, spin.
Cheers, Tuck |
