Navigation Links
Soligenix Announces Results of Recent Data Safety Monitoring Board Review for Phase 3 orBec® Study in Acute GI GVHD
Date:9/15/2011

PRINCETON, N.J., Sept. 15, 2011 /PRNewswire/ -- Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced that an independent Data Safety Monitoring Board (DSMB) recently completed a pre-specified interim analysis for safety and futility for Soligenix's confirmatory Phase 3 clinical trial of orBec® an oral formulation of beclomethasone dipropionate (BDP) in acute gastrointestinal Graft-versus-Host disease (GI GVHD).

The DSMB recommended that the study be stopped as it is highly unlikely to achieve the predetermined primary objective of efficacy based on the interim results. No safety concerns were raised. As a result of the DSMB's recommendation, patient enrollment in the study will stop and the data will be analyzed.

"We are obviously disappointed with the outcome of the DSMB's review," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Over the coming weeks, we will be analyzing the data.  At this point, we do not know why the primary efficacy endpoint was not demonstrated by orBec®, as two prior studies with very similar designs demonstrated robust efficacy and clinically relevant results in essentially the same patient population. It is not possible at this exact time to determine what explains this unexpected outcome. One of a number of possibilities that will be investigated is that these results may be due to changes in the overall treatment practices of the allogeneic stem cell transplantation patient population that may have had an impact on the treatment effect of orBec® since the previous Phase 3 study was concluded in 2004. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from orBec® therapy, then we will certainly communicate our findings."  

Dr. Schaber continued, "With approximately $7.4 million of cash, we can continu
'/>"/>

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

Page: 1 2 3 4 5 6

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. Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant
9. Soligenix to Present at the Rodman & Renshaw Healthcare Conference on September 15, 2010 at 10AM EDT
10. Soligenix Announces Preliminary Results of its Phase 2 Clinical Trial of orBec® in the Prevention of Acute GVHD
11. Soligenix Announces Positive Preliminary Results of SGX202 in Radiation Injury
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... N.C. , July 11, 2014 ... approaches are evolving across industry sectors to better ... examining better ways to engage with and understand ... inform themselves and make critical purchasing decisions. ... firm, Best Practices, LLC, one area where organizations ...
(Date:7/11/2014)...  Kindred Hospital Houston Northwest, with Wound Care ... its new outpatient wound healing center.  The wound ... chronic, hard to heal wounds. Chronic wounds include ... lower leg wounds related to blood flow issues, ... injury wounds which are complex and demonstrate delayed ...
(Date:7/11/2014)... LOUIS , July 11, 2014 /PRNewswire/ ... device company, announced today the positive, cost-effective ... its innovative SPiNPerc™ procedure. The SPiNPerc endobronchial ... of a percutaneous approach to biopsy when ... Hospitals, patients and physicians experience positive financial ...
Breaking Medicine Technology:New Technologies Transforming Consumer Marketing Research Playbook 2Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Veran Medical Publishes Lung Cancer Patient Management Study 2
... WASHINGTON, Nov. 2, 2011 The Long Term Care ... by the Centers for Medicare and Medicaid Services (CMS) ... as a consideration of the Conditions of Participation for ... Our member companies and individual pharmacists have ...
... AMSTERDAM, November 2, 2011 Elsevier, ... information products and services, announced today that its ... purchase on SciVerse ScienceDirect, Elsevier,s online platform for ... in the breadth and depth of the eBook ...
Cached Medicine Technology:Proposed CMS Changes Related to Consultant Pharmacists Raise Profound Concerns for Pharmacies 2Elsevier Announces New 2012 Frontlist eBooks Collection on SciVerse ScienceDirect Available for Advance Purchase 2Elsevier Announces New 2012 Frontlist eBooks Collection on SciVerse ScienceDirect Available for Advance Purchase 3
(Date:7/11/2014)... Oakland, CA (PRWEB) July 11, 2014 Ticket ... tickets at the Concord Pavilion . When it comes to ... from Luke Bryan. The 37-year-old Georgia native is one of the ... in the entertainment business. Bryan is currently out on his “That’s ... Among the many stops the tour will be making through the ...
(Date:7/11/2014)... Alliance for Cancer Gene Therapy, ... exclusively to cell and gene therapies for cancer ... the organization as Senior Development Officer. , Corday ... securing gifts and addressing influential donors. Prior to ... for NewYork Presbyterian Hospital/Columbia University Medical Center, where ...
(Date:7/11/2014)... Global enterprises today are shifting towards the changing ... Managed services offer these global enterprises a strategic method ... into rising operational costs to companies. The aim to ... the global market driver for expanding the managed services ... market is estimated to grow from $142.75 billion in ...
(Date:7/11/2014)... July 11, 2014 Presently, disposable medical ... healthcare equipment and supplies segment. During the past two ... steady growth (on an average 12.5% per year), primarily ... settings. Currently, the US is the largest market for ... share of 40%. The second position is held by ...
(Date:7/11/2014)... Researchers from The Miriam Hospital have found that ... significantly higher rates of smoking than those without ... less likely to attempt quitting than those without ... be sufficient for this population. The study and ... print in the American Journal of Public ...
Breaking Medicine News(10 mins):Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 2Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 3Health News:Alliance for Cancer Gene Therapy (ACGT) Welcomes Joshua Corday as Senior Development Officer 2Health News:Alliance for Cancer Gene Therapy (ACGT) Welcomes Joshua Corday as Senior Development Officer 3Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 4Health News:Global Disposable Medical Supplies Market to See Robust Growth Through Next Decade, According to New TriMark Report Available at MarketPublishers.com 2Health News:Global Disposable Medical Supplies Market to See Robust Growth Through Next Decade, According to New TriMark Report Available at MarketPublishers.com 3Health News:Miriam Hospital study examines smoking prevalence 2
... curry spice turmeric, may help slow down tumor growth ... (ADT), a study from researchers at Jefferson,s Kimmel ... recent issue of Cancer Research , Karen ... and Radiation Oncology at Thomas Jefferson University , ...
... New research presented at the 2012 Annual Meeting of ... more than 4.5 million Americans are living with a ... surgeries has more than doubled over the past decade, ... to be the primary reason for TKR., Investigators used ...
... study to be presented today at the Society for ... Dallas, Texas, researchers will report findings that indicate that ... who deliver or intend to deliver outside of hospitals, ... for home births compared to hospital births. The ...
... Feb. 9 (HealthDay News) -- A growing number of Americans ... social networking sites rather than friends, a new survey ... information from social media such as Facebook and Twitter, a ... number of patients who sought information from friends fell from ...
... , THURSDAY, Feb. 9 (HealthDay News) -- ... their doctor to engage in regular exercise has increased ... from U.S. health officials. The U.S. Centers for ... could help more Americans lower their risk for chronic ...
... clinically challenging and under-studied subset of diseases affecting the ... and Gorham,s disease is the focus of a special ... peer-reviewed journal published by Mary Ann Liebert, Inc. ... www.liebertpub.com/lrb Guest Editor, and Journal Associate ...
Cached Medicine News:Health News:Curry spice component may help slow prostate tumor growth 2Health News:4.5 million Americans living with total knee replacement 2Health News:More Patients Seek Plastic Surgery Advice From Facebook, Twitter 2Health News:More U.S. Doctors Are Urging Patients to Exercise: CDC 2
... 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 ...
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
Medicine Products: