SOURCE: DOR BioPharma, Inc.

June 30, 2008 08:30 ET

DOR BioPharma Announces Collaboration With Numoda Corporation for the Execution of Confirmatory, Phase 3 Clinical Trial of orBec®

EWING, NJ--(Marketwire - June 30, 2008) - DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company"), a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced today that it has entered into a collaboration with Numoda Corporation (Numoda), experts in rapid information turnaround, for the execution of its upcoming confirmatory, Phase 3 clinical trial of orBec® for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD).

Collaborating with Numoda will allow DOR to take full advantage of a comprehensive scope of services including using their robust industry benchmarking capabilities to develop an accurate operational and financial plan including the use of an extensive and proprietary management and oversight capabilities process. Most importantly, Numoda's highly accelerated and efficient data lock at the end of the clinical trial expedites completion of the study while also increasing quality. Barring any unforeseen modifications to the Phase 3 clinical program, Numoda will guarantee the agreed clinical trial budget against cost overruns. As part of the collaboration, Numoda will also take an equity position in DOR common stock in exchange for a portion of its services in connection with the conduct of DOR's upcoming confirmatory Phase 3 clinical trial. Working with Numoda, DOR will be also able to take full advantage of early reporting of results to potential licensing partners and others.

"It is exciting to be working with DOR on this vital clinical project that has the potential to offer a logical answer to the urgent unmet medical need of GI GVHD," said Christopher Mather, Senior Vice President of Numoda. "We look forward to working with DOR's clinical, regulatory and medical team to bring this product to the patients who so desperately need a therapeutic option."

"We are very pleased to be working with Numoda," said Christopher J. Schaber, PhD, President and CEO of DOR. "Numoda is extremely well-regarded in the industry. We believe that Numoda will perfectly supplement our executive management team, including our esteemed Medical Advisory Board, by providing operational, financial and logistical services, as well as unparalleled clinical trial norms through reporting of information that will be essential to the conduct of a successful Phase 3 clinical study. There will be proactive management of the trial in a live format ensuring that the trial will be conducted efficiently and in a high-quality manner."

Dr. Schaber added, "We are also pleased with Numoda's willingness to invest in our Company as we move into this very important program."

About Numoda Corporation

As a growth partner to life science companies, Numoda Corporation opens up client's options, fast, through Improved Norms™, including data lock within hours of the last patient visit. Information services and process management are applied for improved norms in corporate and business development, financial, and product development. As the experts in rapid turnaround of information, Numoda provides an integrated study report at the beginning of a clinical trial versus the industry norm for providing information at the conclusion of a clinical study or project. Through information consolidation and reporting, Numoda delivers visibility and transparency that has proven to profit life sciences companies by enabling fast funding and partnering, fast trial starts and closeouts, and fast to deliver the value of predictable outcomes -- with certainty. More information on Numoda is available at

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of bone marrow transplantation. DOR filed a New Drug Application for orBec® with the FDA for the treatment of acute GI GVHD and received a not approvable letter in which the FDA has requested data from a confirmatory Phase 3 clinical trial to demonstrate the safety and efficacy of orBec®. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has initiated a development program with its Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin, botulinum toxin and anthrax. DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, Inc., please visit the Company's website located at

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, enter into a definitive agreement with IDIS for a NPAP for orBec® for the treatment of GI GVHD, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.