DOR Investors Look Towards orBEC Phase 3 Trial
DOR BioPharma, Inc. [[DORB.OB]] is a biopharmaceutical company that develops products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and provides vaccines for certain bioterrorism agents. However, most investors are focused on just one of the company’s drugs, orBec, which is set to enroll its Phase 3 trial very soon, according to regulatory filings with the Securities and Exchange Commission.
DOR BioPharma’s orBec is a first-of-its-kind two-tablet system designed to combat upper and lower GI GVHD. This debilitating and painful disease is common among immunocompromised cancer patients receiving allogeneic stem cell or bone marrow transplants. Unlike like organ transplants, in GVHD donor cells begin to attack the patient’s body, and can cause anorexia, nausea, vomiting and diarrhea, and even death if left untreated.
Two prior randomized, double-blinded, placebo-controlled Phase 2 and 3 clinical trials demonstrate that orBec provides clinically meaningful outcomes when compared with the current standard of care. Recently, the company reached an agreement with the FDA on the design of a confirmatory, pivotal Phase 3 trial in collaboration with Numoda Corporation. And enrollment into the trial is expected to occur in the second half of 2009, according to the company’s latest 10-K filing with the SEC.
DOR BioPharma also signed a collaboration and supply agreement with Sigma-Tau for the commercialization of orBec. Under this agreement, DOR BioPharma will receive $1 million upon the enrollment of the first patient in the Phase 3 trial, along with additional milestone payments that could total $10 million. Sigma-Tau will also pay a 35% royalty on net sales as well as commercialization expenses, including launch activities.
Currently, there are no approved products to treat GI GVHD, while there are more than 10,000 allogeneic bone marrow and stem cell transplantations that occur each year in the U.S. The company estimated that approximately 50% of this population would be eligible to use its drug, which equates to a large market potential if approved. And this makes DOR BioPharma a stock worth watching as it begins testing of its most promising drug.
CONTACT: Daniel Minton, Managing Director, 406-862-5400, daniel@accelerize.com