Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Lidak Pharm. [LDAKA] -- Ignore unavailable to you. Want to Upgrade?

To: telebob who wrote (808)	1/6/1998 9:50:00 AM
From: MCorbley	Read Replies (2) \| Respond to of 1115

LIDAK REPORTS PAIN RELIEF DATA FROM EARLY-STAGE TREATMENT AND RESULTS FROM LATE-STAGE TREATMENT PHASE 3 ORAL HERPES TRIALS LA JOLLA, Calif., May 16 /PRNewswire/ -- LIDAK Pharmaceuticals (Nasdaq-NMM: LDAKA) reported new data regarding pain relief and additional new healing-time data from its Phase 3 U.S./Canadian clinical trials of n-docosanol 10% cream (LIDAKOL(R)) as a topical treatment for recurrent oral herpes. In the clinical trials, a total of 1192 patients were divided among two early-stage studies and one late-stage study. Early-stage treatment was started during the onset of oral herpes episodes before development of a blister. Late-stage treatment was started after blisters and/or ulcers had already appeared. The trials were purposely conducted as separate early- and late-stage studies to identify potentially different effects of treatment initiated at different stages of an episode. Early-Stage Treatment Studies On March 14, 1996, LIDAK reported preliminary results from the two early-stage treatment studies regarding overall time-to-healing and frequency of aborted episodes. The duration of oral herpes episodes among the LIDAKOL-treated patients in these studies was significantly reduced from an average duration of 8.9 days in prior untreated episodes experienced by these patients to an average of 5.5 days. Unexpectedly, treatment with the intended placebo, containing a substitute compound for n-docosanol, was equivalent to treatment with LIDAKOL in shortening healing times in these studies. These findings raise the possibility that the intended placebo exerted unanticipated anti-herpes activity. The new data reported today suggest that early-stage treatment with LIDAKOL or with the control formulation shortens the duration of pain symptoms associated with recurrent herpes episodes. In the two studies, respectively, patients experienced complete elimination of pain in 2.6 and 4.0 days compared to 6.0 days when the disease is left untreated, as published in the scientific literature. Commenting on these findings, LIDAK's president and chief executive officer, David H. Katz, M.D., stated, "We believe that reduction of pain is of significance to the many patients suffering from this disease. These new data indicating that treatment with LIDAKOL provides pain relief, combined with the previously reported data demonstrating shortened healing times and an increased incidence of aborted episodes, provides further support to our belief that LIDAKOL has the potential to offer meaningful therapeutic relief to patients suffering from recurrent oral herpes." Late-Stage Study The third Phase 3 clinical trial demonstrated that late-stage treatment (with either LIDAKOL or the intended placebo) was ineffective in altering overall healing times in recurrent oral herpes episodes. This result was not surprising in view of the known mechanism of action of LIDAKOL. LIDAKOL's mechanism of antiviral activity is an interference with an early stage of infection when infecting herpes viruses begin to enter their target cells. The initiation of treatment after virus has entered the target cells and has subsequently multiplied is likely to be beyond the point at which LIDAKOL is most active. Therefore, while the Company did not expect late-stage treatment to be as effective as early-stage treatment in shortening recurrent herpes episodes, good clinical practice and trial design dictated that this study be conducted to explore all aspects of LIDAKOL's clinical profile. The healing times averaged 6.9 days from initiation of treatment. Since late treatment generally began 1 to 2 days after the episodes started, the overall healing times were essentially the same as those of untreated episodes (8 to 9 days). Data on possible treatment benefits on pain symptoms at these later stages were inconclusive. Future Clinical Development Plans In reference to the Company's progress in defining the next steps in the LIDAKOL clinical development program, Dr. Katz said, "The unexpected activity of the intended placebo used in these studies makes it necessary for us to conduct additional clinical trials to prove the efficacy of LIDAKOL. The important task now in progress is the selection of such a suitable alternative placebo to use in the next Phase 3 trials which, if successful, will allow us to apply for FDA marketing approval." "We are working closely with the FDA and with Bristol-Myers Squibb and Yamanouchi Europe B.V., our major licensing partners associated with these U.S./Canadian trials, to move our development efforts forward as rapidly as possible. In addition, clinical development programs in other territories, such as Japan, in which placebo-controlled studies have not yet been conducted, will move forward using the alternative placebo ultimately selected for the next Phase 3 studies," Dr. Katz concluded. LIDAK Pharmaceuticals is developing therapeutic products against virally caused diseases, inflammatory disorders and cancer. The information contained in this press release should be reviewed in conjunction with the Company's Annual Report on Form 10-K and other publicly available information regarding the Company, copies of which are available from the Company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business, including risks and uncertainties related to drug development and clinical trials. CONTACT: Michael H. Lorber, VP/CFO, or Lisa Dawn Katz, Investor Relations Administrator, both of LIDAK, 619-558-0364