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DOR BioPharma Announces $940,000 FDA Orphan Products Grant for Clinical Development of RiVax(TM)

Posted on: Monday, 30 July 2007, 09:13 CDT

DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced today that the Office of Orphan Products Development (OOPD) of the Food and Drug Administration (FDA) has awarded a development grant for the further clinical evaluation of its vaccine for ricin toxin, RiVax(TM). The grant has been awarded to UT Southwestern Medical Center, one of the Company's academic partners in the development of RiVax(TM). The Principal Investigator for the project is Ellen S. Vitetta, PhD, Director of the Cancer Immunobiology Center at UT Southwestern. The award totals approximately $940,000 for three years and is to be used for the evaluation of an adjuvant for use with the vaccine. Typically, awards made by the OOPD are to support clinical trials for development of products that address rare diseases or medicines that would be used in numerically small populations.

RiVax(TM) was evaluated in a small dose escalating Phase 1 clinical trial in human volunteers conducted at UT Southwestern. It was shown to be well tolerated and immunogenic especially at the highest dose levels of the vaccine given three times at monthly intervals. The vaccine induced antibodies that were correlated to protection from toxin exposure, including the capacity to neutralize the toxin. Further, the functional activity of the antibodies was established by demonstrating that transfer of serum globulins from the vaccinated individuals to mice resulted in their survival subsequent to ricin toxin exposure. The results of that confirmatory trial underpin the current effort to develop an adjuvant form of the vaccine, which is intended to enhance human antibodies' responses to the vaccine and increase their durability and rapidity of onset.

RiVax(TM) is a recombinant subunit of one of the components of ricin toxin and has been genetically detoxified. The subunit is produced in recombinant bacterial hosts, purified, and formulated with an adjuvant.

"The Phase 1 clinical trial was done to establish that we had inactivated the toxin sufficiently to remove any possible local toxicity that could be associated with intramuscular injection," said Dr. Vitetta. "Having confirmed the fundamental immunogenicity in humans, we are ready to test the immunogenicity and safety of the vaccine with an adjuvant that we expect to induce long-lasting antibodies with lower doses of the vaccine."

"The award to UT Southwestern is one part of the overall development program, which includes large scale process development, stability testing, and development of animal models that demonstrate efficacy as correlates of the human immune response," said Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "We are continuing to transition the early development of this vaccine from UT Southwestern to commercial production, and are relying on these results as the basis for broader Phase 2 studies of the vaccine in humans."

The Company has been developing RiVax(TM) in a consortium effort between academic and industrial partners under several separate NIAID grants totaling approximately $14 Million. In addition to UT Southwestern, development partners include, Stanford Research Institute (SRI International), the University of Kansas, Lonza Baltimore, and the Wadsworth Center of the New York State Department of Health in Albany. Complementing the current OOPD grant, Dr. Ellen Vitetta has also separately been awarded a grant for $2.2 million over 5 years to conduct research in fundamental areas to develop novel vaccine formulations and characterize immune responses in small animals. The outcome of that novel research will help support ongoing development of RiVax(TM).

About ricin toxin

Ricin toxin is a potent plant toxin easily produced from abundantly available castor beans. There is no vaccine to protect against exposure and no post-exposure therapeutic other than supportive care. Ricin is highly toxic to humans and other mammals and is thought to be a bioterror threat because of its environmental stability and high potency, second only to botulinum toxin as a natural toxin. Exposure to small amounts can lead to lung damage if inhaled, rapid onset of nausea, fever, and abdominal pain if ingested. General organ failure leading to death can occur within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. The successful development of an effective vaccine against ricin toxin may act as a deterrent in the actual use of ricin as a biological weapon and can be used in rapid deployment scenarios in the event of a biological attack.

About the Office of Orphan Products Development.

The Office of Orphan Products Development (OOPD) is dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions since 1982. OOPD interacts with the medical and research communities, professional organizations, academia, and the pharmaceutical industry, as well as rare disease groups. The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. The OOPD administers the Orphan Products Grants Program which provides funding for clinical research in rare diseases.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a 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(R) (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA for orBec(R) with the FDA for the treatment of GI GVHD, and subsequent to supplemental information recently submitted, the FDA has extended the PDUFA (Prescription Drug User Fee Act) date to October 21, 2007. An MAA (Marketing Authorization Application) with the EMEA (European Medicines Evaluation Agency) has also been filed and validated. orBec(R) may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has also recently initiated a development program with its Lipid Polymer Micelle (LPM(TM)) oral 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 recently enacted 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 and botulinum toxin. DOR's ricin toxin vaccine, RiVax(TM), has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

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

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(R) for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec(R). 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(R), 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 U.S. Government or other countries, that the U.S. 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(R) for gastrointestinal GVHD include the risks that: because orBec(R) did not achieve statistical significance in its primary endpoint in the pivotal Phase 3 clinical study (i.e. a p-value of less than or equal to 0.05), the Oncologic Drug Advisory Committee ("ODAC") appointed by the FDA voted that the data supporting orBec(R) did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of GI GVHD, although the FDA is not bound by ODAC's decision, the FDA may not consider orBec(R) approvable

based upon existing studies, orBec(R) may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; 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; or orBec(R) may not gain market acceptance; and others may develop technologies or products superior to orBec(R). 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.

 Company Contact: Evan Myrianthopoulos Chief Financial Officer (786) 425-3848 www.dorbiopharma.com

SOURCE: DOR BioPharma, Inc.

Source: MARKET WIRE

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