Navigation Links
Glycotex' Investigational Compound GLYC-101 Achieves Accelerated Wound Closure Based on Interim Analysis
Date:4/7/2009

ROCKVILLE, Md., April 7 /PRNewswire/ -- Glycotex, Inc. today announced the completion of a scheduled interim analysis in a Phase II study evaluating the effect of investigational GLYC-101 gel on complete wound closure and cosmetic outcomes in cosmetic surgery patients undergoing carbon dioxide laser skin resurfacing on the lower eyelid area.

The interim analysis was conducted after 26 subjects completed the study. The comparison of each active arm to placebo with respect to the primary endpoint (time to complete wound closure) shows positive results when considering the full dataset of patient data from all treatment combinations.

Specifically, the efficacy outcomes were statistically significantly different when comparing GLYC-101 0.1% and GLYC-101 1.0% groups to placebo (p values are 0.0062 and 0.0331, respectively). These interim results suggest that the time to wound closure will be shorter for eyelids treated on the active arms when compared to placebo in the final analysis. Assessment of safety data is ongoing.

This ongoing Phase II randomized, double-blind, placebo-controlled clinical study will continue enrolment to approximately 48 patients at one clinical trial site in Beverly Hills, California. Patients are randomized to receive either GLYC-101 0.1%, GLYC-101 1.0%, or placebo gel on one lower eyelid, and a different test article on the other lower eyelid applied topically to the laser-ablated area immediately following the laser procedure and for four consecutive days thereafter for a total of five applications. The primary efficacy endpoint of the study is time to complete wound healing, and the secondary efficacy point is cosmetic outcomes, including scarring. The study is observing the effects of the topical agent over the course of one month following the initial treatment with the investigational compound (GLYC-101 gel) or placebo.

About GLYC-101

A previous Phase II Pilot Study, investigating clinical outcomes and safety parameters of GLYC-101 gel at two doses compared to placebo, was completed in April 2008.

GLYC-101 is being developed to stimulate and modulate the natural cascade of wound healing activities of several cell populations. The product candidate is a topical gel to be applied directly on the wound surface. In May 2006, Glycotex completed a Phase II clinical trial of GLYC-101 in Australia, in which GLYC-101 produced a statistically significant rate of wound area reduction versus combined placebo and standard care in patients with chronic venous ulcers. The results provided proof-of concept and dose-ranging information for GLYC-101.

The strategic priorities for GLYC-101 include wound healing following laser ablation, burn wounds, surgical wounds, venous ulcers, and diabetic ulcers.

About Glycotex, Inc.

Glycotex, Inc. is a U.S. based development stage biopharmaceutical company focused on discovering and developing therapies intended to accelerate human wound healing and tissue repair across a wide range of human applications. It has licensed from Novogen Limited certain patent rights and know-how to use and exploit its technology in a wide range of wound healing applications. Glycotex, Inc. is an 81 percent owned subsidiary of Novogen Limited. For more information, visit www.glycotexinc.com.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure of our products to obtain such approval; uncertainties or differences in interpretation of clinical trial results; our inability to maintain or enter into, and the risks resulting from, our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.


'/>"/>
SOURCE Glycotex, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
2. A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol
3. Ardea Biosciences, Inc. Announces Completion of Phase 1 Clinical Trials of Novel Investigational HIV Drug RDEA806
4. ECLIPSE Data on Effects of Otsukas Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients Hemodynamics and Urine Output Featured in Heart Failure Society of Americas Late Breaking Trials
5. Replidynes Investigational Antibacterial Agent REP3123 Prevents Sporulation in Clostridium difficile
6. Replidynes Investigational Antibacterial Agent REP3123 Prevents Toxin Production in Clostridium difficile
7. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
8. Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
9. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
10. Lexicon Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
11. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... VIEW, Calif., Feb. 4, 2016  Omnicell, Inc. (NASDAQ: ... management solutions to healthcare systems, today announced results for ... --> --> GAAP ... $130.3 million, up $5.1 million or 4.1% from the ... 7.2% from the fourth quarter of 2014. Revenue for ...
(Date:2/4/2016)... SILVER SPRING, Md. , Feb. 4, 2016 ... Robert Califf , the FDA,s Deputy Commissioner for Medical Products ... far-reaching action plan to reassess the agency,s approach to opioid ... the epidemic, while still providing patients in pain access to ... The FDA will: , Re-examine the risk-benefit ...
(Date:2/4/2016)... India , February 4, 2016 ... the new Market Research Report "North American Automated External ... Fully-Automated External Defibrillators), by End-User (Public Facilities, Hospitals, Homecare ... American automated external defibrillators (AED) report defines and segments ... the revenue. This market is estimated to grow to ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Successful recruitment and retention ... and scientific initiatives have all marked the last 12 months at Roswell Park ... of the nation’s oldest cancer center, Candace S. Johnson, PhD, outlined the many ...
(Date:2/5/2016)... ... February 05, 2016 , ... The Muscular Dystrophy Association and ... launched the 14th annual “Appetite for a Cure” campaign on Feb. 1 to ... and related diseases that severely limit strength and mobility. , Now through ...
(Date:2/5/2016)... York, New York (PRWEB) , ... February 05, 2016 , ... ... life? The answer may be at the tips of your toes. Foot massage, whether ... as well as pure comfort and relaxation. The American Board of Multiple Specialties ...
(Date:2/5/2016)... Ontario (PRWEB) , ... February 05, 2016 , ... After ... Scarborough General Hospital Burn Unit, plastic and cosmetic surgeon Dr. Wayne Carman transitioned to ... Scarborough Hospital. He successfully completed his first three-year term as chief and began a ...
(Date:2/5/2016)... ... 05, 2016 , ... US Sports Camps , official operators of Nike ... high-performance kids yoga training. ChildLight Yoga Studio is centrally situated in the picturesque New ... ChildLight Yoga Studio founder Lisa Flynn expresses her excitement, “We are thrilled to be ...
Breaking Medicine News(10 mins):