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Miami, FL. US | Jan. 25, 2006 | DOR BioPharma, Inc. (AMEX: DOR) (“DOR'', or the “ Company'') today announced that it has
successfully completed the second development milestone for its ricin vaccine, called RiVax™, under the Challenge Grant 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. For the second milestone, the Company has completed the development of a process for large-scale manufacture of the key vaccine ingredient consisting of a modified ricin toxin subunit protein. In addition, supplementary characterization and formulation objectives have been achieved.
DOR is developing the vaccine under the Challenge Grant in conjunction with the University of Texas Southwestern Medical Center, Stanford Research Institute, University of Kansas, and Cambrex Biosciences in Baltimore. This consortium led by DOR has resulted in development of a robust and reproducible manufacturing process and purification scheme for large-scale production of the ricin A chain subunit protein ingredient in RiVaxTM. This process will be sufficient to supply millions of vaccine doses. The ricin A chain is the catalytic subunit of ricin toxin that accounts for its main ability to inhibit protein synthesis and kill mammalian cells. Modification of the A chain to remove toxicity sites was required to make a vaccine safe enough and effective enough for use in humans. An early formulation of RiVaxTM using a smaller scale process has been evaluated in a Phase I clinical trial in healthy volunteers, the first time such a vaccine has been tested in humans. The major results of that trial will be announced next week and discussed in publication.
Based on the improved production methods and high yields of RiVax™, DOR is manufacturing clinical batches which will be evaluated in additional human studies to examine the effect of the formulation and vaccination regimen on the human immune response. Continuing studies in animals are focused on correlating the level of antibodies in serum with protection against ricin exposure to various routes of exposure, including aerosol and oral. The demonstration of the functionality of human antibodies and passive protection in animals is a key step in providing evidence of efficacy under the FDA Animal Efficacy 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 very pleased with the progress we continue to make with our ricin program,'' stated Michael T. Sember, DOR's CEO and President. “We now have a well defined and scalable manufacturing process that is suitable for all future commercial needs as we continue development of this important biodefense countermeasure. We will continue to work closely with our partners and NIAID to expeditiously develop a safe and efficacious ricin vaccine.”
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. There currently are no FDA approved vaccines against ricin toxin.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of biodefense vaccines and therapeutics for areas of unmet medical needs. Through its BioDefense Division, DOR is developing bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin. DOR's lead therapeutic product, orBec® (an oral formulation of beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed to treat inflammation in the mucosal lining of the intestine and stomach that can occur following allogeneic bone marrow and stem cell transplants. For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.
Forward Looking Statements
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. 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, 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 enter into profitable biodefense contracts with the U.S. Government and 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. 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.
SOURCE: DORbiopharma, Inc. |
