Soligenix Receives Award Totaling $244,479 for orBec® Program From Qualifying Therapeutic Discovery Project
Soligenix Receives Award Totaling $244,479 for orBec® Program From Qualifying Therapeutic Discovery Project
Nov. 3, 2010 (PR Newswire) --
PRINCETON, N.J., Nov. 3, 2010 /PRNewswire/ -- Soligenix, Inc. (Soligenix or the Company) (OTC Bulletin Board: SNGX), a late-stage biopharmaceutical company, announced today that the Company has been awarded a cash grant totaling $244,479 under the U.S. Internal Revenue Service's Qualifying Therapeutic Discovery Project (QTDP) program. The awards are intended for projects designed to treat or prevent diseases by conducting studies for the purpose of securing approval from the U.S. Food and Drug Administration.
Under the recently enacted Patient Protection and Affordable Care Act of 2010, cash grants were awarded to qualified research and development projects that showed significant potential in producing new and cost-saving therapies, support job growth, and increase U.S. competitiveness. Grants were awarded through a competitive application process, and Soligenix's confirmatory Phase 3 orBec® program for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD) qualified for an award.
"We are pleased to have been awarded this grant, and believe it is a positive reflection on the value of the confirmatory Phase 3 orBec® clinical trial in acute GI GVHD which is currently underway," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "This grant represents non-dilutive financing and therefore has a positive impact on our balance sheet."
The Internal Revenue Service issued the QTDP awards and will administer the program pursuant to section 48D of the Internal Revenue Code. The QTDP program is designed to provide grants or tax credits to qualified biotechnology companies with fewer than 250 employees that demonstrate the potential to:
Develop new therapies to treat chronic conditions or unmet medical needs;
Reduce long-term health care costs in the United States; or
Significantly advance the goal of curing cancer within 30 years.
About Soligenix, Inc.
Soligenix, Inc. (Soligenix) 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. Soligenix's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. orBec® is currently the subject of a $1.2M FDA Orphan Products Grant supported confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD. Soligenix is also conducting an NIH-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis. Additionally, Soligenix has a Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.
Through its Biodefense Division, Soligenix is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. Soligenix's lead biodefense product in development is a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax™ is also the subject of a $9.4 million NIH grant received by the Company supporting development of new heat stable vaccines.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect Soligenix, 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. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, SGX201, RiVax™, and LPM™, 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® for gastrointestinal GVHD include the risks that: the FDA's requirement that Soligenix 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; Soligenix 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®. Factors affecting the development and use of SGX201 and LPM™ are similar to those affecting orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
SOURCE Soligenix, Inc.
Evan Myrianthopoulos, Chief Financial Officer, Soligenix, Inc., +1-609-538-8200
Source: PR Newswire (November 3, 2010 - 8:00 AM EDT)
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