Navigation Links
Glycotex' Investigational Compound GLYC-101 Achieves Accelerated Wound Closure Based on Interim Analysis

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

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:
(Date:11/26/2015)... PUNE, India , November ... --> ... / personal emergency response system ... grow steadily for 5 years ... growing region expected to see ...
(Date:11/26/2015)... November 26, 2015 --> ... combination approach blends immunotherapy with Bremachlorin-photodynamic therapy for advanced ... approach blends immunotherapy with Bremachlorin-photodynamic therapy for advanced cancer. ... approach blends immunotherapy with Bremachlorin-photodynamic therapy for advanced cancer. ... has found that immunotherapy can be efficiently combined with ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 Research and ... "Asia Pacific Cardiac Pacemaker Market Outlook to 2019 - ... Drive the Demand " report to their offering. ... --> Boston scientific and others. ... global players including Medtronic, Biotronik, Boston ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... ... the toilets were," said an inventor from Hillside, N.J. "Many people catch diseases ... cover so that individuals will always be protected from germs." , He developed ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent with the ... 2016 Building Better Radiology Marketing Programs meeting will showcase some of the ... 2016, at Caesars Palace in Las Vegas with a pre-conference session on a ...
(Date:11/27/2015)... Los Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... the Commission on Accreditation of Allied Health Education Programs (CAAHEP) awarded accreditation to its ... exclusive list of CAAHEP accredited colleges, as only one of twelve colleges and universities ...
(Date:11/26/2015)... Marne, MI (PRWEB) , ... November 26, 2015 ... ... center for substance abuse located in central Michigan, have come together on Thanksgiving ... a specially produced video, available for viewing on the Serenity Point YouTube channel, ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical laboratories and ... offered by healthcare staffing agency Aureus Medical Group . These fields, ... 2015 among those searching for healthcare jobs through the company’s website, ...
Breaking Medicine News(10 mins):