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

To: pinewoods who wrote (892)	2/2/1998 12:57:00 PM
From: henry jakala	Read Replies (2) \| Respond to of 1115

try freeedgar.com very interesting - still reason for hope with LDAKA i guess

To: pinewoods who wrote (892)	2/2/1998 11:31:00 PM
From: luis a. garcia	Read Replies (1) \| Respond to of 1115

freeedgar.com RESEARCH AND DEVELOPMENT LIDAKOL Company scientists have developed a therapeutic compound, n-docosanol,trademarked under the name LIDAKOL, which has demonstrated in non-clinical trials a range of anti-viral activities and other therapeutic properties in promoting wound healing and in reducing acute inflammatory reactions. The compound was thoroughly examined for pre-clinical toxicity and then placed into the clinical development path of a FDA-allowed IND as a topical treatment for recurrent oral-facial herpes, commonly called cold sores or fever blisters. Early human testing proved that LIDAKOL 10% cream had an excellent safety profile and displayed clinical effectiveness in Phase 2 placebo-controlled trials in limited numbers of patients. - 28 - In 1995, the Company's European licensing partner, Yamanouchi Europe b.v., completed a Phase 3 clinical trial of LIDAKOL in early treatment of recurrent herpes episodes. In this double blind study, LIDAKOL was compared to acyclovir (Zovirax(R)) 5% cream in approximately 400 patients initiating treatment at early stages of a recurrent herpes episode. Results of this trial demonstrated that LIDAKOL showed statistically comparable therapeutic efficacy to Zovirax 5% cream, a product approved for marketing in Europe as a treatment for recurrent oral herpes, but which is not approved for marketing or available in the U.S., (Zovirax ointment, which is available in the U.S., has not been approved by the FDA for use as a treatment for recurrent oral herpes). Demonstrating comparable efficacy to an approved product is one of the requirements for obtaining regulatory approval in most major European countries, but is not a requirement for approval in the U.S.. Results of this trial, along with results from the U.S. Phase 3 placebo-controlled trials described below, will be used by Yamanouchi Europe for submission to the appropriate regulatory agencies for marketing approval in Europe. In Spring 1996, the Company obtained the results of three double-blind placebo-controlled Phase 3 U.S. and Canadian clinical trials of LIDAKOL 10% cream as a topical treatment for recurrent oral herpes in over 1,200 immunocompetent patients. Two of these studies involved 648 patients who initiated treatment early in a recurrent herpes episode (before the vesicle stage). The third study evaluated 544 patients who initiated treatment at later stages of an episode (when vesicles and/or ulcers had already appeared). In all three studies, LIDAKOL had a very good safety profile and was well-tolerated. The first two trials did not demonstrate a statistically significant difference between LIDAKOL and the intended placebo and, therefore, did not provide the Company with a basis for filing a NDA with the FDA for marketing approval of LIDAKOL. The Company believes that the cream used as the intended placebo displayed unexpected anti-herpes activity and, thus, adversely affected these trial results. The third Phase 3 U.S./Canadian late treatment study of LIDAKOL demonstrated that late stage treatment was ineffective in altering overall healing times. The outcome of this third trial was expected by the Company in view of its understanding of the mode of action of LIDAKOL, in which interference with viral infection occurs early when infecting herpes viruses begin to enter target cells, rather than after the virus has entered the cell and begun to multiply. if these trials had shown a statistically and clinically significant advantage of LIDAKOL versus placebo, the Company could have filed a NDA with the FDA for marketing approval of LIDAKOL as a treatment of recurrent oral herpes. However, as noted, LIDAKOL did not show a statistically significant difference in healing times versus the cream used as the intended placebo in the trials. As a result of this outcome and because the Company believed that the cream used as the intended placebo displayed unexpected anti-herpes activity, the Company conducted additional clinical trials to prove the efficacy of LIDAKOL compared to what it believed to be an alternative, inert placebo. The Company initiated two Phase 3 studies (96-LID-06 and 96-LID-07) in the U.S. in July and September, 1996, both of which were early-treatment protocols. Almost 750 patients were evaluated in these double-blind, placebo-controlled studies, the primary endpoint of which was overall time-to-healing, with secondary endpoints including percentage of aborted outbreaks and relief of pain symptoms. The studies were conducted at many of the same sites used in earlier Phase 3 studies of LIDAKOL. In August, 1997, the Company reported that in the primary end-point of these trials, treatment of acute herpes episodes with LIDAKOL resulted in a statistically significant (P=0.0076) reduction of the healing times versus the placebo control. LIDAKOL also demonstrated statistically significant (P=0.0027) reduction in the time until patients were free of herpes-associated symptoms, which included pain, itching, tingling and burning. As observed in previous studies, there was a higher incidence of aborted outbreaks in LIDAKOL-treated versus placebo-treated patients. In one subset of patients, the difference in aborted episodes between LIDAKOL and placebo treatments was statistically significant (P=0.048), but the difference was not statistically significant among all patient subsets. - 29 - These trial results provided the Company with the final clinical evidence to support all of the requirements for filing a NDA with the FDA for marketing approval of LIDAKOL in the United States as a treatment of recurrent oral herpes. On December 22, 1997, the Company filed its NDA with the FDA for marketing approval for LIDAKOL in the United States as a treatment of recurrent oral herpes. If the NDA is approved by the FDA, the Company believes that commercial sales could commence shortly thereafter. luis