Scottsdale 7/3/2013 3:00:00 AM
Soligenix (SNGX) Completes Phase 1 Study with SGX203, Treatment of Pediatric Crohn’s Disease
QualityStocks would like to highlight Soligenix, Inc. (OTCBB: SNGX), a development stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix has two areas of focus: 1) a therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as oral mucositis, pediatric Crohn’s disease, acute radiation enteritis, and Graft-versus-Host disease (GVHD), and 2) a vaccine/biodefense segment to develop vaccines and therapeutics for military and civilian applications.
In the company’s news,
Soligenix has enrolled and treated all 24 patients in the phase 1 Study BDP-PCD-01, the first clinical study for development of SGX203 (oral BDP) for the treatment of pediatric Crohn’s disease.
The objective of Study BDP-PCD-01 was to further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the company’s proprietary oral BDP formulation. Soligenix reports that the data was complementary to results previously obtained and confirms the safety profile observed in all previous clinical studies with oral BDP.
This study enrolled subjects between the ages of 18-22. The company said preliminary PK results indicate that the PK profile in this population matches the profile established in previous studies in a broader population and supports a twice-a-day dosing regimen. SGX203 was found to be safe and well-tolerated.
“We have designed this program in collaboration with an expert in PK modeling and simulation, Jeffrey S. Barrett, PhD, FCP, from The Children’s Hospital of Philadelphia,” Kevin J. Horgan, MD, senior vice president and chief medical officer of Soligenix stated in the press release. “The use of PK data in this way reflects the current state of the art in pediatric drug development, leveraging the maximum amount of information from the enrolled subjects.”
Soligenix will use the PK data generated from the study to refine the PK model the company has established with Dr. Barrett, and is expected to justify limited PK sampling in the phase 2/3 pediatric clinical study and help determine the dose selection for the phase 3 study.
The SGX203 development program previously received Fast Track and Orphan Drug designations from the U.S. FDA for oral BDP as a treatment for pediatric Crohn’s disease.
About QualityStocks
QualityStocks, based in Scottsdale, Arizona, is a free service that collects data from hundreds of Small-Cap and Micro-Cap online Investment Newsletters into one Daily Newsletter Report. QualityStocks is dedicated to assisting emerging public companies with their investor communication efforts and connecting subscribers with companies that have huge potential to succeed in the short and long-term future.
To sign up for The QualityStocks Daily Newsletter, please visit www.QualityStocks.com
To connect with QualityStocks via Facebook, please visit http://Facebook.com/QualityStocksPage
To connect with QualityStocks via Twitter, please visit http://Twitter.com/QualityStocks
Please read FULL disclaimer on the QualityStocks website: http://Disclaimer.QualityStocks.com
Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.
