Fashion And Beauty

BTG plc (LSE:BGC), the life sciences company, announces that the full results of the US phase II safety study of Varisolve® are being presented today at the American College of Phlebology (ACP) 22nd Annual Congress. The results confirm that treatment with Varisolve® in subjects with right-to-left (R-L) cardiac shunts, which may allow residual bubbles following treatment to enter the cerebral arterial circulation, does not cause cerebral injury.

Principal investigator Kathleen Gibson, MD, of Lake Washington Vascular Surgeons, commented: “There is increasing interest in using foam sclerosant to treat varicose veins, because of the many benefits to patients including the speed of treatment and no requirement for general or tumescent anaesthesia. However, concerns have been raised relating to the potential risk of cerebral gas embolisation, particularly in patients who have a right-to-left cardiac shunt that may allow residual bubbles from the foam to enter the arterial circulation. This study found no evidence of any injury to the brain, retina or heart following treatment with the proprietary Varisolve® polidocanol microfoam in patients with cardiac shunts. These results should not be generalised to other foams, such as air-based foams that have high nitrogen content and are insoluble in blood.”

Louise Makin, chief executive officer of BTG, said: “It was very important for the future development and commercial potential of Varisolve® to demonstrate no subclinical effects following treatment in the brains of people with a cardiac shunt. Having removed this uncertainty, we have been able to press ahead with confidence both with partnering discussions and with the pilot phase III trials, in anticipation of the pivotal phase III trials that are planned to begin around mid-2009.”

Dr Gibson’s oral presentation,Proprietary Polidocanol Endovenous Microfoam Bubble Embolization Does Not Cause Cerebral Injury, will describe the multi-centre phase II safety study. Eligible patients were screened for the presence of a R-L shunt and if positive were given a baseline diffusion-weighted brain MRI scan. Patients were then treated with Varisolve® and monitored for 60 minutes following treatment using Transcranial Doppler (TCD) to detect bubbles entering the middle cerebral artery (MCA). Additional safety evaluations included blood oximetry, cardiac markers and electrocardiograms. Patients with detected MCA bubbles had follow-up diffusion-weighted brain MRI scans 24 hours and 28 days after treatment, neurological and visual field examinations plus other routine assessments. The study objective was to treat and follow up 50 patients with detected MCA bubbles.

Of 82 patients treated, 73% (60) had detection of MCA bubbles and all had at least one post-treatment MRI. No new MRI lesions or abnormal findings in the neurological and visual field examinations were detected in any patients, and none had any evidence of cardiac ischaemia.

Sapheno-femoral junction reflux was eliminated in 94% of patients at one month, and 88% had occlusion of the great saphenous vein. Adverse events were generally mild and transient and were consistent with previous experience with Varisolve®.

In a second oral presentation at ACP entitled Neurological and Visual Symptoms Following Treatment of the Saphenous Veins with Two Formulations of Polidocanol Endovenous Microfoam, Janet Rush, MD, BTG’s Head of US Regulatory & Medical Affairs, will describe the characteristics of the Varisolve® microfoam before and following its reformulation to minimise residual gas bubbles. Dr Rush will also compare clinical experience and results from studies of the original formulation (7% nitrogen) and the new formulation (0.01-0.8% nitrogen). She will conclude that of 534 patients treated with the original formulation, one patient (who had a cardiac shunt) had potentially clinically concerning neurological symptoms, while there have been no clinically concerning neurological or visual symptoms in any of the 106 patients treated with the new formulation.

A third oral presentation, by David Wright, MB, FRCS, BTG’s Vice President of Medical Affairs, entitled A Single-Center Pilot Study of Polidocanol Endovenous Microfoam (PEM) Treatment to Evaluate Presence and Durability of Gas Emboli Using Echocardiography, will explore the relative echocardiographic appearances of the original and new formulations of Varisolve®, with the objective of determining whether nitrogen ingress can “stabilise” small bubbles thereby causing them to persist in the circulatory system. Twenty patients were randomised to receive treatment with the original or new formulation of Varisolve®, and 10 additional patients were also randomised to pre-breathe oxygen or not. This was to explore whether pre-breathing oxygen would de-nitrogenate the blood sufficiently to prevent any stabilisation of the bubbles that might occur.

Dr Wright will conclude that all patients receiving endovenous microfoam ablation treatment have right sided cardiac bubbles. He will also conclude that the echocardiographic appearance is unaltered by elimination of nitrogen, and that pre-breathing with oxygen does not change the presence of bubbles. Treatment of the varicose veins was successful with all 35 patients (including 5 training patients) having occlusion of the great saphenous vein and elimination of reflux at 28 days.

In addition to the oral presentations, Gregory Suplick, BTG’s Vice President of Clinical Development, will present two poster presentations entitled Patient Recruitment Strategies and Referrals Associated with a Multicenter Phase II Study of Patients with GSV Incompetence and Patient Pre-Qualification Tools Used to Recruit Patients for a Multicenter Phase II Study of Patients with GSV Incompetence.

About BTG

BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka.

BTG

In 1991, the Food and Drug Administration (FDA) issued guidelines prohibiting the marketing of injectable liquid silicone for any cosmetic purpose. The FDA has since approved monitored clinical studies investigating the safety and efficacy of injectable silicone, but none has been completed as yet. Long-term follow-up will be key to evaluating any studies. In the meantime, some practitioners continue to purchase liquid silicone intended for the treatment of retinal detachment and inject it for aesthetic improvements. It is the position of the American Society for Aesthetic Plastic Surgery (ASAPS) that the safety of the use of liquid injectable silicone for cosmetic purposes is controversial, and that it should not be used outside legitimately approved clinical trials.

Reported Benefits:

Clinical investigation of liquid silicone injection for the correction of facial deformities took place from 1978 to 1988 under FDA-approved and monitored protocols. For many of these deformities, liquid silicone represented the only hope for treatment at that time. According to investigators, liquid silicone injections resulted in substantial improvements of the deformities with some complications. Good results have also been reported with the use of liquid injectable silicone for cosmetic purposes, such as correction of wrinkles, creases and scars. Unlike collagen or fat, liquid silicone does not need to be repeatedly injected to achieve the desired effect.

Other Considerations:

Once injected, liquid silicone cannot be altered or removed. Many reports of complications have been published, including severe complications from liquid silicone used for breast enlargement as long ago as the 1950s. Almost all of the problems noted were never seen by the injecting physician and tended to occur years after injection. Among the complications cited were:

- Movement of silicone to other parts of the body
- Inflammation and discoloration of surrounding tissue
- Formation of masses of chronically inflamed tissue

In addition, liquid silicone comes in different grades:

- Industrial: developed only for non-medical uses

- Medical grade: A silicone product has recently been approved by the FDA specifically for ophthalmic use in the treatment of retinal detachment. Although this product which generated most of the problems seen through the years, any cosmetic use would be “off label,” and the same potential risks noted above would still be of concern.

ASAPS Position:

The safety of the injection of liquid silicone for cosmetic purposes remains highly controversial. Many other effective alternative treatments for wrinkles or acne scars are available and may be discussed with an aesthetic plastic surgeon certified by the American Board of Plastic Surgery. Liquid silicone from any source should never be injected into the breasts.

This document was updated from October, 2001.

The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS) is the only plastic surgery organization devoted entirely to the advancement of cosmetic surgery. ASAPS is recognized throughout the world as the authoritative source for cosmetic surgery education. U.S. members are certified by the American Board of Plastic Surgery. Canadian members are certified in plastic surgery by the Royal College of Physicians and Surgeons of Canada.

American Society for Aesthetic Plastic Surgery

Glycotex, Inc. announced enrollment of the first patient in a Phase IIb study evaluating the effect of GLYC-101 on wound closure and cosmetic outcomes in cosmetic surgery patients undergoing carbon dioxide laser skin resurfacing on the lower eyelid area.

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

The current randomized, double-blind, placebo-controlled clinical study will enroll approximately 48 patients at one clinical trial site in Beverly Hills, California. Patients will be randomized to receive either GLYC-101 0.1% or GLYC-101 1.0% gel on one lower eyelid, and placebo on the other lower eyelid applied topically to the laser-ablated area immediately following the laser procedure and for four consecutive days thereafter. The primary efficacy endpoint of the study is time to wound healing, and the secondary efficacy point is cosmetic outcomes, including scarring. The study will observe the effects of the topical agent over the course of one month following the initial treatment with the investigational compound and placebo.

About GLYC-101

GLYC-101 is intended 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 http://www.glycotexinc.com