Navigation Links
Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant
Date:8/23/2010

PRINCETON, N.J., Aug. 23 /PRNewswire-FirstCall/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.

The grant will be used  to defray a significant portion of the costs associated with the conduct of the Company's ongoing, confirmatory, Phase 3 clinical trial of orBec® in acute gastrointestinal Graft-versus-Host-Disease (GI GVHD).  This trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec® Randomized Treatment Study), will enroll an estimated 166 subjects to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. The primary endpoint in the SUPPORTS protocol is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value 0.005) in the Company's previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec® (i.e., 30 days following cessation of treatment).  The Phase 3 study includes major stem cell transplantation centers in the United States, Europe and Australia, and is expected to complete in the first half of 2011.

"We are grateful to have been awarded this significant grant to support our ongoing confirmatory Phase 3 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe the award is a validation of the design of our Phase 3 trial and a clear indicator of the importance of orBec® and its potential application in the treatment
'/>"/>

SOURCE Soligenix, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Soligenix Announces Publication of Positive Stability Results with RiVax(TM), its Vaccine Against Ricin Toxin
2. Soligenix Announces Publication of Positive Pre-Clinical Results with RiVax(TM), Its Vaccine Against Ricin Toxin
3. Soligenix Announces Initiation of a Phase 1/2 Clinical Trial of SGX201 for the Prevention of Acute Radiation Enteritis
4. Soligenix Forms Consortium to Develop Thermostable Technology to Advance RiVax(TM) and Other Rapidly Acting Vaccines
5. Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology
6. Soligenix Announces Publication of Positive Data Describing Protection from Mucosal and Systemic Ricin Intoxication by Intradermal RiVax™ Administration
7. Soligenix to Present at the OneMedForum Conference on Wednesday, June 30 at 2PM EDT
8. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
9. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... , Switzerland , October 1, 2014 ... in Clinical Genomics and Next Generation Sequencing (NGS) data ... clinicians to run full cystic fibrosis analysis in a ... identification and characterisation of all types of variants in ... Until now, it has not been possible ...
(Date:9/30/2014)... 30, 2014 This report analyzes the worldwide markets ... Product Categories: Enteral Feeding Pumps, Nasogastric Tubes, and Others. ... Canada, Japan , Europe ... , and Rest of World. Annual estimates and forecasts ... six-year historic analysis is provided for these markets. ...
(Date:9/30/2014)... Mass. , Sept. 30, 2014  Hologic, Inc. ... Stephen MacMillan , Hologic,s President and Chief Executive Officer, ... Ceremony on October 1, the first day of Breast ... discuss the Company,s campaign focused on the important benefits ... approved by the FDA as clinically superior to traditional ...
Breaking Medicine Technology:Sophia Genetics Launches Full CFTR Analysis in Single Clinical Grade NGS Experiment 2Global Enteral Feeding Devices Industry 2Global Enteral Feeding Devices Industry 3Global Enteral Feeding Devices Industry 4Global Enteral Feeding Devices Industry 5Global Enteral Feeding Devices Industry 6Global Enteral Feeding Devices Industry 7Global Enteral Feeding Devices Industry 8Global Enteral Feeding Devices Industry 9Global Enteral Feeding Devices Industry 10Global Enteral Feeding Devices Industry 11Global Enteral Feeding Devices Industry 12Global Enteral Feeding Devices Industry 13Global Enteral Feeding Devices Industry 14Global Enteral Feeding Devices Industry 15Global Enteral Feeding Devices Industry 16Global Enteral Feeding Devices Industry 17Global Enteral Feeding Devices Industry 18Global Enteral Feeding Devices Industry 19Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 3
(Date:10/1/2014)... 2014 Phoseon Technology, the pioneer in ... expand the business worldwide. This rapid growth includes increased ... for manufacturing efforts. The company has experienced average annual ... and expects this growth to continue in the future ... worldwide adoption. , “We are very pleased that ...
(Date:10/1/2014)... from Duke Medicine suggests that some people who are ... hard-wired to gain weight when exposed to chronic stress, ... 13 percent of people, all of whom are Caucasian, ... help them reduce heart disease with simple interventions such ... "Genetic susceptibility, psychosocial stress and metabolic factors act in ...
(Date:10/1/2014)... Diet Doc understands that many of their clients have ... dieting attempts could be easily sabotaged by the temptation to ... into their programs as a way to control the ... weight loss results, it also allows patients to stick with ... weight for the future. , Earlier versions of the hormone ...
(Date:10/1/2014)... 2014 On Sept. 9, Chapín Coffee ... the Martha Stewart American Made Awards (MSAMAs), an annual ... country in the fields of crafts, design, food and ... a finalist in the MSAMAs, which celebrates entrepreneurs and ... improving local communities and changing the way we shop, ...
(Date:10/1/2014)... WOODLAND HILLS, CA (PRWEB) October 01, 2014 ... Mamaly Reshad will speak to a group of dental ... week in the northern Spain city of Oviedo. Dr. ... known prosthodontist and lecturer with clients on two continents, ... mouth complex and aesthetic full mouth reconstruction. , “These ...
Breaking Medicine News(10 mins):Health News:Phoseon Technology Continues to Drive Growth Worldwide 2Health News:Gene interacts with stress and leads to heart disease in some people 2Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 2Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 3Health News:Diet Doc Announces Their New Version of the Hormone Diet Plan to Target, Attack and Burn Fat Without Dangerous Side Effects 4Health News:Chicago Coffee Start-up Makes a Big Impact, Earns National Recognition 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 2Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 3Health News:Woodland Hills Dental Implants Expert Training Dental Specialists in Spain Later This Week 4
... Joel T. Allison, FACHE, president/CEO of Baylor Health Care ... of the Texas Hospital Association,s Earl M. Collier Award ... Collier Award is the highest honor bestowed by THA. ... annual Leadership Conference in Austin."Joel Allison exemplifies the leadership ...
... 22 ATS Medical, Inc.,(Nasdaq: ATSI ... and services, today announced its participation in the ... (STS) and related,company-sponsored events. The meeting runs ... as one of the year,s key gatherings of,cardiovascular ...
... School of Medicine have discovered how a whole class ... Their findings, reported online this week at the ... Edition, suggest that a subgroup of cancer patients might ... of chemotherapeutics doxorubicin (Adriamycin), daunorubicin, epirubicin, idarubicin ...
... N.C., Jan. 22 Nearly 2,500 dentists, dental,hygienists, dental ... take part in the sixth annual national "Give Kids ... to be among the largest events of its kind,in ... other dental professionals will volunteer their time at,designated dental ...
... Recovery Group, Inc. (IRG) announce the formation of Impairment Resources, ... assure accurate and reliable impairment ratings. Impairment Resources will combine ... of the AMA Guides to the Evaluation of Permanent Impairment, ... ...
... fuel rise in employee engagementMINNEAPOLIS, Jan. 22 ... productivity solutions grew in 2008, due to ... incentives. HealthFitness (NYSE Alternext US: FIT) is ... and fitness management solutions for on-site and ...
Cached Medicine News:Health News:Allison Honored with Hospital Association's Highest Award 2Health News:Allison Honored with Hospital Association's Highest Award 3Health News:ATS Medical Announces Participation in 45th Annual Society of Thoracic Surgeons Meeting 2Health News:ATS Medical Announces Participation in 45th Annual Society of Thoracic Surgeons Meeting 3Health News:ATS Medical Announces Participation in 45th Annual Society of Thoracic Surgeons Meeting 4Health News:How chemotherapy drugs block blood vessel growth, slow cancer spread 2Health News:How chemotherapy drugs block blood vessel growth, slow cancer spread 3Health News:North Carolina Dentists Team Up To Treat Needy Children 2Health News:Brigham and Associates and Insurance Recovery Group Launch Impairment Resources, a Joint Venture to Address Impairment Ratings 2Health News:Brigham and Associates and Insurance Recovery Group Launch Impairment Resources, a Joint Venture to Address Impairment Ratings 3Health News:Biometric Screening, Health Coaching and HRA Participation Grows in 2008 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: