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

To: henry jakala who wrote (731)	12/23/1997 9:36:00 AM
From: luis a. garcia	Read Replies (1) \| Respond to of 1115

HEY Guys.... Company Press Release SOURCE: LIDAK Pharmaceuticals LIDAK Pharmaceuticals Submits New Drug Application To Market New Herpes Drug LA JOLLA, Calif., Dec. 23 /PRNewswire/ -- LIDAK Pharmaceuticals (Nasdaq: LDAKA - news) announced today that it has filed a New Drug Application (NDA) for its herpes drug, LIDAKOL(R), with the U.S. Food and Drug Administration (FDA). With this NDA submission, LIDAK is seeking approval for marketing LIDAKOL (n-docosanol 10% cream) as a topical treatment for recurrent oral herpes (cold sores or fever blisters). LIDAKOL is a therapeutic compound, developed by Company scientists, which has demonstrated a broad spectrum of anti-viral activities and other therapeutic properties in promoting wound healing and in reducing acute inflammatory reactions. ''All of us at LIDAK are proud to have achieved this major milestone,'' said David H. Katz, M.D., president and CEO of LIDAK. ''In particular, I want to express my profound appreciation to the LIDAK team which assembled this application in apparently record time. This NDA is the culmination of an intensive research and clinical development program of many years' duration. We look forward to a positive completion of the FDA review process so that we can make this product available to consumers,'' Dr. Katz concluded. The NDA has been submitted four months after the successful completion of LIDAK's pivotal Phase 3 clinical trials. Almost 750 patients were evaluated in two double-blind, placebo-controlled studies which evaluated LIDAKOL in the treatment of recurrent oral herpes. The primary endpoint of the studies was overall time-to-healing. Secondary endpoints evaluated percentage of aborted outbreaks and relief of pain symptoms. The primary end-point evaluation of these trials showed that treatment with LIDAKOL resulted in a statistically significant reduction of the healing times of acute herpes episodes versus the placebo control. Contrasting with the 8 to 10 days normal duration of untreated herpes episodes, LIDAKOL-treated patients were healed in an average of 4.1 days from beginning-to-end of their outbreaks. In secondary end-point evaluations, LIDAKOL-treated patients were completely relieved of their major herpes-associated symptoms, such as pain, itching, tingling and burning, significantly faster than the placebo-treated patients. Moreover, as observed in previous studies there was a higher incidence of aborted outbreaks in LIDAKOL-treated versus placebo-treated patients. Finally, an additional endpoint demonstrated in earlier studies showed that LIDAKOL substantially decreased the duration of viral shedding from active lesions, thereby shortening the most contagious portion of the acute episode when herpes could be transmitted to another person. Herpes simplex virus is one of the most common and easily spread viral infections in the world. In the U.S. alone, one in three adults suffers from the herpes virus. Oral herpes is the more prevalent form, but over 50 million Americans have the genital form of herpes, and there are 500,000 new cases diagnosed each year. There is no currently-known cure for herpes once the disease is contracted. The market potential of a topical cream for the treatment of oral herpes is substantial. Currently, only 18% (or less) of herpes infected patients are treated because the relatively few drugs that have FDA approval are expensive, are variable in effectiveness and no currently approved drug has shown the ability to abort acute outbreaks. Worldwide sales of the most widely used and approved therapy for the treatment of herpes simplex virus, acyclovir/Zovirax(R) (in all of its forms), surpassed $1.3 billion dollars in 1996. LIDAK Pharmaceuticals is developing therapeutic products against virally caused diseases, allergies and asthma, inflammatory disorders and cancer. We are on OUR WAY with this one.........yeeehehhhhehheheheeheeh!!!!!! luis

To: henry jakala who wrote (731)	12/23/1997 10:55:00 AM
From: John Zwiener	Read Replies (1) \| Respond to of 1115

To all (3 of you), I do have some reservation as to how the press releases were worded. In a second press release, they are even less clear that the 8-10 days refers to the placebo group... LIDAK said it submitted its application to the Food and Drug Administration four months after Phase III clinical trials showed the drug reduced healing time and symptoms in treated patients. <<<<It said patients treated with Lidakol were healed in an average of 4.1 days, compared with eight to 10 days in most untreated cases.>>>>> Notice that they say "compare with eight to 10 days in MOST untreated cases"...... In the other press release, they don't specifically say placebo, but say NORMAL duration. I'm sorry, but at this time I feel they continue to be vague. As scientists, they know the correct buzzwords to specify what they mean. They must compare Lidakol treated versus the placebo control group (not the normal duration). Lidak continues to be evasive,