DOR BioPharma Reports Achievement of Two-Year Stability Milestonefor RiVax, its Vaccine Against Ricin Toxin
DOR Submits Application for RiVaxTM in Response to BARDA Biodefense RFP
EWING, NJ - January 29, 2008 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or "The Company") announced today that it has successfully achieved a two-year milestone in the long-term stability program of the key ingredient of RiVax™, a recombinant subunit vaccine against ricin toxin. RiVax™ is intended to protect against exposure to ricin toxin that might result from the purposeful release of ricin in an aerosolized form, or as a poisonous contaminant in food or water.
The results of the two-year analysis undertaken as part of the formal stability program demonstrate that the immunogen component of RiVax™, a recombinant derivative of the ricin A chain, is stable under storage conditions for at least two years without loss of its natural configuration or the appearance of any detectable degradation products. A vaccine is considered by many to be the best way to prospectively protect populations at risk of exposure against ricin toxin. As this vaccine would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack, the activity of the vaccine must be maintained over a period of years under stockpile storage conditions.
Robust stability is one of the key factors stipulated by the Biomedical Advanced Research and Development Authority (BARDA) for vaccines to be included in the Strategic National Stockpile. BARDA has placed a priority on stability and a rapid onset of immunity in no more than two vaccine doses as the stability and efficacy targets for vaccines under development for both category A and category B vaccines. BARDA has recently issued a Request for Procurement (RFP) entitled "Biodefense Vaccine Enhancement," to which DOR has submitted an application for RiVaxTM. BARDA is a new agency within the US Department of Health and Human Services (HHS) established to implement acquisition under the Project Bioshield Act and to foster the development of vaccines and countermeasures such as RiVax™ that have achieved milestone hurdles, and are candidates for continued development. To this end, BARDA has solicited proposals in a number of key areas, including development of vaccines for category categories B and A that have enhanced stability properties that address long-term storage and the benefit of rapid onset of immunity. DOR regularly applies for biodefense grants, as well as RFPs when appropriate, from the National Institutes of Health (NIH) and other applicable governmental bodies that support biodefense.
"We believe that RiVax™ is a useful countermeasure against ricin toxin, and that our vaccine incorporates many of the desirable properties that should make it amenable to long-term stability as part of the overall mission to develop countermeasure components for the Strategic National Stockpile," said Robert N. Brey, PhD, Chief Scientific Officer of DOR. "The potential use of ricin toxin as a weapon of mass destruction was recently identified by the FBI as one of the top two bioterror threats this country faces. We have previously completed a Phase 1 clinical trial of RiVaxTM which demonstrated both safety and immunogenicity, and we are also able to produce RiVaxTM under GMP conditions at large scale."
DOR has studied the stability of the RiVax™ immunogen
using a variety of spectral techniques aimed at examining the
three-dimensional and two-dimensional structure of the protein, as
well as other techniques that detect small changes in the nature of
the protein during exposure to elevated temperature
conditions. These results have shown that certain common
materials can be added to solutions of the protein to maintain the
stable configuration that is thought to be correlated with optimal
immune response in animals. Without stabilization of the
protein structure, the ricin A chain subunit component is extremely
sensitive to elevated temperatures and forms aggregates and other
complexes that negatively affect shelf life.
About Ricin Toxin
The potential use of ricin toxin as a biological weapon of mass
destruction has been highlighted in a recent FBI Bioterror report
released last November entitled Terrorism 2002-2005, which states
that "Ricin and the bacterial agent anthrax are emerging as the
most prevalent agents involved in WMD investigations" (http://www.fbi.gov/publications/terror/terrorism2002_2005.pdf).
Ricin toxin is a potent plant toxin that can be easily produced
from abundantly available castor beans. Ricin toxin is highly toxic
to humans and other mammals and is thought to be a bioterror threat
because of its stability and high potency, as well as the large
worldwide reservoir as a by-product of castor oil production. It is
second only to botulinum toxin as the most lethal natural toxin.
Exposure to small amounts can lead to lung damage if inhaled with
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 toxin
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 against the actual use of ricin
as a biological weapon and could be used in rapid deployment
scenarios in the event of a biological attack.
DOR BioPharma, Inc. believes it is the world leader in ricin
toxin vaccine research. RiVax™ is DOR's proprietary vaccine
developed to protect against exposure to ricin toxin and the first
ricin toxin vaccine ever to be clinically tested in humans. There
are currently no vaccines available to prevent ricin poisoning or
medical treatments to care for poisoning victims. DOR has announced
positive Phase 1 clinical trial results for RiVax™ which
demonstrated that the vaccine is well tolerated and induces
antibodies in humans that neutralize the ricin toxin. The
functional activity of the antibodies was confirmed by animal
challenge studies in mice that survived exposure to ricin toxin
after being injected with serum samples from the volunteers. The
outcome of the study was recently published in the Proceedings of
the National Academy of Sciences. The Phase 1 clinical trial was
conducted by Dr. Ellen Vitetta at the UT Southwestern Medical
Center at Dallas (UT Southwestern), DOR's academic partner on the
RiVax™ program. DOR and UT Southwestern have together
received approximately $15 million in grant funding from the NIH
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® (oral beclomethasone dipropionate), 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 an additional clinical trial to demonstrate the safety and efficacy of orBec®. A Marketing Authorization Application with the European Medicines Evaluation Agency has also been validated and is under review. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. orBec® 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, as well as a development program with its oral azathioprine technology for the treatment of oral GVHD.
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 and botulinum toxin. DOR's ricin toxin vaccine, RiVaxTM, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
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, 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.
DOR BioPharma, Inc.
Chief Financial Officer
Posted: January 2008