Message #2 From:
NewsBot Date: July 6, 2006 06:25:00 AM
DORB News DOR BioPharma Announces Successful Completion of cGMP Production Milestone for RiVax(TM)
MIAMI--(BUSINESS WIRE)--July 6, 2006--DOR BioPharma, Inc. (OTCBB:DORB) ("DOR" or the "Company"), announced today that it has successfully completed its cGMP (current Good Manufacturing Practices) milestone for the production of RiVax(TM), DOR's vaccine against ricin toxin. The milestone was achieved in the performance of a Challenge Grant totaling $6.4 million previously awarded to DOR in September 2004 by the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the National Institutes of Health. The safety and immunogenicity of RiVax(TM) has recently been evaluated in a Phase I clinical trial in healthy volunteers, and the results were published earlier this year in the Proceedings of the National Academy of Sciences.
DOR and its manufacturing partner, Cambrex BioSciences Baltimore, Inc., have developed a robust and reproducible manufacturing process for the large-scale production of RiVax(TM). The completion of cGMP manufacture of RiVax(TM) forms one of the crucial milestones in the performance of the work conducted under the NIH grant. Based on the release and further toxicology testing of the cGMP batches, the Company is planning to test the vaccine in further clinical trials. These trials will examine the influence of an immunological adjuvant formulation and vaccination regimen on the human immune response. These studies will be directed towards providing safety and immunogenicity data needed for licensure of the vaccine by the FDA. Further animal testing is also planned to provide correlation of antibody levels in human serum with protection against ricin exposure in animal models. Because vaccine efficacy for exposure of humans to ricin toxin can only be tested in animals, the FDA has established a two animal rule. Under this rule, the FDA can permit human licensure of a vaccine by relying on results from animal trials when human trials cannot ethically evaluate efficacy.
"We are pleased that we have achieved this critical milestone and are encouraged that we will have a means to manufacture RiVax(TM) at the scale necessary for potential future immunization programs of civilian or military personnel," stated Michael T. Sember, President and CEO of DOR BioPharma. "We are well on the pathway to successful development of RiVax(TM) as we continue work on this important biodefense countermeasure. We will continue to work closely with our partners and NIAID to propel the vaccine through the next phase of clinical studies."
Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses, ease of manufacture, and ability to be aerosolized. Exposure to small amounts, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and death within several days. The need for protective countermeasures against ricin has been emphasized by its recent and continued use as a biological weapon. Currently there are no FDA approved vaccines or therapeutics against ricin toxin.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common serious complication of bone marrow transplantation for cancer, as well as other GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of GI GVHD in the July - August timeframe of 2006.
Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(TM), has successfully completed a Phase I clinical trial in normal volunteers. We have also initiated a botulinum toxin therapeutic development program based on rational drug design.
For further information regarding DOR BioPharma, please visit the Company's website located at http://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'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 BioPharma 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 BioPharma 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 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 III clinical study (i.e. a p-value of less than or equal to 0.05), 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 BioPharma expects or may never gain approval; DOR BioPharma 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 BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma 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.
