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Acyclovir Delivered Across the Skin

Release issued 5th July 2001

Lake Park, Florida - TransDermal Technologies, Inc. announced today the release of its latest pre-clinical data validating its patent-pending, patchless, liquid transdermal delivery system, TDS(tm) in the delivery of Acyclovir.

The study, overseen by Prof. Derek Willoughby and completed by Dr. Chandan A.S. Alam, of the Department of Experimental Pathology of the William Harvey Institute at St. Bartholomew's and the Royal London School of Medicine and Dentistry, measured the ability of the TDS technology to deliver Acyclovir across the skin in a sufficient dose to accomplish a therapeutic outcome without a patch or other appliance. Data from the study confirms company claims that the TDS technology enables rapid penetration and increased blood concentrations of Acyclovir. This trial documents the sixth drug delivered successfully utilizing the TDS technology.

The model for the study was the white rat. Blood samples were obtained at thirty minutes, one hour and two hours. The formulation was successful at delivering a dose of the drug doubling in concentration through the timepoints. Concentrations at 30 minutes averaged 100 ng/dL. At one hour the average was 189 ng/dL and at two hours the average was 368 ng/dL. These results were deemed exciting by Dr. Alam and the faculty at the Harvey Institute and are certainly indicative of further development.

The need for alternative dosing capability as provided by transdermal means is particularly felt in the case of anti- viral drugs, which in the acute phase of outbreaks often must be dosed rapidly to achieve optimal outcomes and which often are quite poorly tolerated due to gastro- intestinal distress and liver toxicity issues. The TDS can effectively mitigate all of these issues with anti-infectives. The TDS accomplishes the therapeutic outcome that the drug is designed for with much smaller doses than oral equivalents as demonstrated in the company's successful pre-clinical studies of other drugs. By bypassing the gut and first-pass circulation from the gut to the liver, GI distress and liver toxicity are eliminated or minimized. The TDS can be modified to deliver a concentrated dose to a local area, which is not broadly distributed throughout the body. This capability, coupled with the smaller doses possible with the TDS(tm) enables much safer anti-infective dosing that virtually eliminates the side effects.

Acyclovir in its patented form known as Zovirex(R) (Glaxo) has been a potent anti-viral therapy used to treat outbreaks of Varicella Zoster virus also known as Herpes Zoster, commonly known as Shingles. The Varicella Zoster virus which causes Shingles is the same virus responsible for the disease, Chicken Pox. After the childhood disease passes, the virus then lays dormant along the dorsal root ganglions of the spinal chord until unknown factors, generally believed to be related to physical or mental stress, triggers its re-emergence as a painful, weeping lesion of the skin or other tissues. Typical victims are undergoing stress from illness or surgery and AIDS patients almost universally suffer from shingles at some point in their battle with disease, often times in recurring bouts. Post-herpetic neuralgia, the chronic residual effect of the acute attack, can cause medium to high level pain for years after the acute phase is passed. If the acute outbreak occurs on or around the eyes, blindness can be the result. The VZV Foundation of New York, a non- profit organization that seeks to educate physicians and the public about the ravages of the Varicella Zoster Virus and the importance of early treatment reports that the efficacy of Acyclovir and other anti-viral therapies and the optimization of outcomes is definitely time-dependent. TransDermal Technologies believes that the proven efficacy of Acyclovir teamed with the TDS and applied to the skin directly above the dorsal root ganglion as well as in the vicinity of the vesicles may prove to be a potent new tool in the fight against Varicella Zoster.

TransDermal Technologies is actively seeking a licensing partner or partners interested in exploiting this technology.

The TDS(tm) is a platform system that is designed to be modified for each application and is believed to enable the rapid, safe and effective delivery of many medicaments across intact skin by means of its sprayed on or applicator applied lotions.

Company Contact: Kenneth B. Kirby - k.kirby@transdermaltechnologies.com / 800-282-5511 / 561-848-9100

Company details

If you want to find out more about the company visit TransDermal Technologies, Inc. profile.

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