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DOR BioPharma Receives EMEA Agreement On The Design Of Its Confirmatory Phase 3 Clinical Trial Of OrBec(R) In GI GVHD
DOR BioPharma, Inc. (DOR or the Company) (OTC Bulletin Board: DORB), a late-stage biopharmaceutical company, announced that it has received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of its confirmatory, pivotal, Phase 3 clinical trial evaluating its lead product orBec(R) for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD).

They Are Young And Need The Job: A Second Chance For Dangerous T-cells
The immune system"s T-cells react to foreign protein fragments and therefore are crucial to combating viruses and bacteria. Errant cells that attack the body"s own material are in most cases driven to cell death. Some of these autoreactive T-cells, however, undergo a kind of reeducation to become "regulatory T-cells" that keep other autoreactive T-cells under control. A group led by immunologist Professor Ludger Klein of LMU Munich has now shown that the developmental stage of an autoreactive T-cell is decisive to its ultimate destiny. Young autoreactive T cells are very readily reeducated into regulatory T-cells. Under identical conditions, however, older T cells become fully activated and can cause damage they are in a way resistant to reeducation. "We now intend to study at the molecular level what makes a T-cell accessible for reeducation," said Klein, "because then it may be possible to convert even normal adult T-cells, which can be obtained easily and in great numbers from blood. Possibly, they could then be used as regulatory T-cells in therapies for autoimmune diseases such as type-1 diabetes or multiple sclerosis: these are diseases that are triggered by uncontrolled autoreactive T-cells." (PNAS, 10 June 2009)
News of the day
DNA Binding Compound That Kills Bacteria In 2 Minutes Could Lead To New Antibiotics
A synthetic DNA binding compound has proved surprisingly effective at binding to the DNA of bacteria and killing all the bacteria it touched within two minutes. The DNA binding properties of the compound were first discovered in the Department of Chemistry at the University of Warwick by Professor Mike Hannon and Professor Alison Rodger (Professor Mike Hannon is now at the University of Birmingham). However the strength of its antibiotic powers have now made it a compound of high interest for University of Warwick researchers working on the development of novel antibiotics.
Sexual Health

Less-Toxic Drug Prolongs Survival In Metastatic Breast Cancer

Research from the Northwestern University Feinberg School of Medicine has found that a less toxic, solvent-free chemotherapy drug more effectively prevents the progression of metastatic breast cancer and has fewer side effects than a commonly used solvent-based drug. A national study led by William Gradishar, M.D., director of breast medical oncology at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, found that the drug Abraxane prolonged progression-free survival by almost seven months compared with Taxotere, which is part of a class of solvent-based drugs called taxanes. "It nearly doubled progression-free survival," said Gradishar, who also is a professor of medicine at Northwestern"s Feinberg School and a physician at Northwestern Memorial Hospital. The study was published May 26 in the Journal of Clinical Oncology. Chemotherapy drugs need to be dissolved in a chemical, called the "delivery system", before they can be injected into the blood stream. Abraxane uses albumin, a human protein, to deliver the chemotherapy. It does not contain chemical solvents. The generic name for Abraxane is nab-paclitaxel. The study showed Abraxane also was much less toxic to patients. Gradishar said solvents are responsible for many of the side effects of chemotherapy including a drop in the white blood cell count and numbness or tingling in the fingertips. In the study, the Abraxane was administered on a weekly schedule compared to injections every three weeks of Taxotere. "This is a win-win finding," Gradishar said. "The weekly schedule of Abraxane has more anti-tumor effects and is better tolerated than Taxotere. There is also evidence that Abraxane is able to deliver the chemotherapy drug more effectively to the tumor." "These results suggest that weekly nab-paclitaxel may be an appropriate alternative to docetaxel (Taxotere) in the first-line treatment of patients with metastatic breast cancer," Gradishar said. The Phase II, open-label, randomized clinical study involved 300 patients with previously untreated metastatic, stage 4 breast cancer. The results were assessed by an independent radiology company and study investigators. The study was designed to evaluate the safety and efficacy of three doses of Abraxane versus the highest standard dose of Taxotere. Metastatic breast cancer is characterized by the spread of a malignant tumor from the breast to other parts of the body. It is estimated that nearly 155,000 women in the U.S. are currently living with metastatic breast cancer. The study was supported by Abraxis BioScience, which manufactures Abraxane. Gradishar is a member of the advisory boards for Abraxis and sanofi-aventis U.S., which manufactures Taxotere. He has received grant support from Abraxis and sanofi-aventis. Marla Paul Northwestern University


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