EWING, N.J., March 25 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc. (DOR or the Company), a late-stage biopharmaceutical company, announced today that it has entered into a $400,000 common stock equity investment agreement priced at market with its clinical trials management partner, Numoda Corporation (Numoda). One hundred thousand dollars of this investment will be completed in January 2010. This investment follows and enhances the collaboration between DOR and Numoda announced June 30, 2008 and represents partial payment by DOR under the collaboration agreement.
Numoda, which specializes in providing life sciences companies with innovative trial-performance metrics in enrollment, logistics, monitoring and financial efficiencies, is currently collaborating with DOR to execute DOR's confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).
"We are pleased to receive this vote of confidence from our partner, Numoda," said Christopher J. Schaber, PhD, President and CEO of DOR. "This investment is in keeping with our philosophy of aligning the interests of our collaborators and subcontractors with those of our shareholders. We believe that making them partners in our success enhances the likelihood of a positive outcome. It is gratifying to me that Numoda shares our passion and excitement over the promise of orBec(R) in acute GI GVHD."
Mary Schaheen, Numoda's Chief Executive Officer, said, "Numoda is very pleased to demonstrate its strong commitment to DOR on the confirmatory Phase 3 clinical trial of orBec(R) in GI GVHD. We are confident in both our ability to deliver high-performance results and in the prospects for a successful clinical trial. We look forward to working with DOR and to successfully completing this Phase 3 clinical trial in an expedient fashion."
The Company's common stock was sold to Numoda in a private placement in reliance on an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The shares have not been registered under the Securities Act or any state securities laws, and the shares may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. In connection with the offering, DOR has agreed to add the shares to its existing pre-effective registration statement. This press release does not and will not constitute an offer to sell or the solicitation of an offer to buy shares and is being issued under Rule 135c under the Securities Act.
About Numoda Corporation
Numoda Corporation is a leading provider of services to promising life sciences companies, offering business evaluation and budget projections and oversight, comprehensive management of clinical trials, patented information management systems and reporting tools with early transparency, and risk-sharing agreements that include direct investment. Numoda's services strengthen the business case for promising new therapies by ensuring efficient deployment of funds and immediate reporting for early assessment of progress. Engaging and partnering with Numoda reinforces confidence in life sciences companies and their clinical trial results, thereby improving conditions for the acquisition of funding, licensing and partnering money for future success.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) is a late-stage 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 or BDP), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of hematopoietic cell transplantation. DOR expects to begin a confirmatory Phase 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 in radiation enteritis in the second half of 2009. orBec(R) is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation. Additionally, DOR has a Lipid Polymer Micelle (LPM(TM)) 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 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, botulinum toxin and anthrax. 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, Inc., please visit the Company's website at www.dorbiopharma.com.
This press release contains forward-looking statements that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. 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 cash expenditures will not exceed projected levels, 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(R) 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(R) 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(R) may not gain market acceptance if it is eventually approved by the FDA; 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 Forms 10-Q and 10-KSB. Unless required by law, DOR assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
CONTACT: Evan Myrianthopoulos, Chief Financial Officer of DOR BioPharma,
Web site: http://www.dorbiopharma.com/