-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VUVwdyzX7NcQYp0ndotOLdNAxMo0Kw4LM5+U946xNpjW5dVts0RuF2IAYQo+VU0X 4LSbLDdbbKC+NRHX5G6Rkg== 0000812796-04-000029.txt : 20040916 0000812796-04-000029.hdr.sgml : 20040916 20040916170351 ACCESSION NUMBER: 0000812796-04-000029 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040130 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20040916 DATE AS OF CHANGE: 20040916 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DOR BIOPHARMA INC CENTRAL INDEX KEY: 0000812796 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 411505029 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16929 FILM NUMBER: 041034332 BUSINESS ADDRESS: STREET 1: 1691 MICHIGAN AVE. STREET 2: SUITE 435 CITY: MIAMI STATE: FL ZIP: 33139 BUSINESS PHONE: 305-534-3383 MAIL ADDRESS: STREET 1: 1691 MICHIGAN AVE. STREET 2: SUITE 435 CITY: MIAMI STATE: FL ZIP: 33139 FORMER COMPANY: FORMER CONFORMED NAME: ENDOREX CORP DATE OF NAME CHANGE: 19960916 FORMER COMPANY: FORMER CONFORMED NAME: IMMUNOTHERAPEUTICS INC DATE OF NAME CHANGE: 19920703 8-K 1 grant8k.htm 8K FOR RICIN GRANT 8K for Ricin Grant



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549


FORM 8-K


CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) September 13, 2004

DOR BioPharma, Inc.
(Exact name of registrant as specified in its charter)


Delaware
 
1-14778
 
41-1505029
 
 



(State or other jurisdiction
 
(Commission
 
(IRS Employer
 
 
of incorporation)
 
File Number)
 
Identification No.)
 
 
         
1691 Michigan, Suite 435, Miami, FL
 
33139
 
 


(Address of principal executive offices)
 
(Zip Code)
 
 



Registrant’s telephone number, including area code (305) 534-3383

Not applicable
(Former name or former address, if changed since last report)

 
     

 
 

Item 7.01 Regulation FD Disclosure.

On September 13, 2004, DOR BioPharma, Inc. (the " Registrant ") issued a press release announcing that it has been awarded a $5.2 million grant from the National Institute of Allergy and Infectious Diseases. A copy of the Registrant’s press release is attached hereto as Exhibit 99.1 and the information contained therein is incorporated herein by reference. The information contained in this Form 8-K, including the exhibit, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, and it shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.


 
 
 Exhibit Number    Description of Exhibits
 99.1    Press Release of Registrant dated September 13, 2004.
 

 
 
     

 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 

     
  DOR BIOPHARMA, INC
 
 
 
 
 
 
Date: September 16, 2004 By:   /s/ Geoff Green
 
  President & Acting Chief Executive Officer



 
     

 
Exhibit Index


 Exhibit Number    Description of Exhibits
 99.1    Press Release of Registrant dated September 13, 2004.


EX-99.1 2 pressreleasegrant.htm RICIN GRANT PRESS RELEASE Ricin Grant Press Release

DOR BIOPHARMA RECEIVES $5.2 MILLION FROM NATIONAL INSTITUTES OF HEALTH FOR CONTINUED DEVELOPMENT OF RICIN VACCINE

Miami, FL, September 13, 2004 — DOR BioPharma, Inc. ("DOR" or the "Company") (AMEX: DOR) announced today that they have been awarded a $5.2 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), for further development of DOR’s ricin vaccine, RiVax?.

"We are pleased to have been awarded a product development grant from NIH, and believe this funding underscores the recognized need for further development of RiVax?," said Dr. Gregory J. Davenport, Ph.D., President of DOR’s BioDefense Division. "This funding will enable us to achieve additional milestones with our industrial partners leading us closer to providing a safe and effective ricin vaccine to our military and at-risk civilians and, ultimately, FDA licensure."

DOR’s BioDefense Division has been developing a ricin toxin vaccine in collaboration with their academic partner, the University of Texas Southwestern Medical Center (UT Southwestern). Under the direction of Dr. Robert Brey, the Principal Investigator for the
grant and DOR’s Chief Scientific Officer, the vaccine has proven to be safe and effective in multiple animal models. "We have made substantial progress with the vaccine, and the funding validates not only the product, but the future development path", stated Dr. Brey. The next steps include conducting an investigator-sponsored phase I pilot study in humans with vaccine previously produced at UT Southwestern, and, with the current grant award, transitioning the manufacturing process into a facility capable of producing commercial doses of the vaccine.

The specific milestones for the RiVax? development program funded under the grant include generation of a stable formulation of RiVax?, development of a robust large scale process for purification of the vaccine, conduct of nonclinical toxicology studies, conduct of aerosol challenge studies to assess the capacity of RiVax? to protect lung surfaces vulnerable to ricin exposure, and production of cGMP (current Good Manufacturing Processes) batches of RiVax?. "If these milestones are successfully achieved, DOR will have sufficient vaccine available for future clinical trials, and will be capable of manufacturing RiVax? for fulfillment of any future procurement contracts", stated Dr. Davenport. Under the recently passed Project Bioshield Act 2004, the federal government has the authority to procure bioterror countermeasures for addition to the National Stockpile, prior to Food and Drug Administration approval, for distribution in the event of an emergency.

Ricin toxin is recognized as a potential bioterror threat due to its lethality in small doses, stability at a large range of temperatures, and ease of manufacture. Purified from the bean of the common castor plant, ricin toxin is the most potent plant-derived toxin known and has no approved vaccine or antidote. Inhalation poisoning is of particular concern because of rapid and irreversible damage to the lungs following exposure to the epithelial layer. Ricin toxin has surfaced in several recent, well-publicized incidents both in the United States and abroad. This, combined with the fact that ricin toxin has been used as a biological weapon in the past, has emphasized the need for protective countermeasures and treatments. The complete ricin toxin is a prototypic A-B toxin, in which the B-chain binds to the target cell and the A chain enters cells and causes disruption of protein synthesis resulting in cell death. RiVax? is a recombinant vaccine bioengineered from the A chain with a mutation that elimina tes the ability of the A chain to disrupt protein synthesis.

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 topical corticosteroid being developed to treat inflammation in the mucosal lining of the gastrointestinal tract, known as Graft-versus-Host Disease, that often occurs following allogeneic bone marrow transplants. A pivotal Phase III clinical trial for orBec® will complete in September and the Company intends to file a New Drug Application (NDA) on positive data. 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'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 t ime 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.


Company Contact:                    
Keith Thornton                    
Investor Relations Manager                        
(305) 534-3383                    
kthornton@dorbiopharma.com
www.dorbiopharma.com
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