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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?

To: zeta1961 who wrote (1803)	6/18/2007 9:55:50 AM
From: Jibacoa	Respond to of 3722

VICL is trading above its Apr H after some news from Japan. The stock is up 13% on moderate volume of 87,500 bigcharts.marketwatch.com Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis Trial in Japan. Monday June 18, 6:30 am ET SAN DIEGO, June 18 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL - News) today announced that the company's licensee, AnGes MG, Inc. reported positive results following interim analysis of data from the first 41 subjects to complete a Phase 3 trial of an angiogenesis product candidate using Vical's DNA delivery technology. Based on the findings that the primary efficacy endpoint in the trial had been achieved with statistical significance and that there were no major safety concerns related to treatment, an Independent Data Monitoring Committee (IDMC) recommended stopping the trial early to prevent potential ethical issues against the placebo group subjects. AnGes is ending the trial and preparing to file an application for Japanese marketing approval. "The successful Phase 3 results from our Japanese licensee position the AnGes product candidate to be the first approved for human use based on our DNA delivery technology and provide proof of concept for DNA delivery in the treatment of disease," said Vijay B. Samant, President and Chief Executive Officer of Vical. "This novel approach has the potential to address an important, unserved medical need in a significant commercial market. We look forward to further updates from AnGes as they advance through the regulatory approval process." The treatment uses Vical technology to deliver a gene encoding Hepatocyte Growth Factor (HGF), a human protein that causes angiogenesis (growth of blood vessels) in areas of ischemia (restricted blood flow). In the trial, 40 subjects with critical limb ischemia (advanced peripheral arterial disease) were evaluated for efficacy. The primary endpoints, improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in the placebo group and 70.4% improvement in the treatment group, a statistically significant difference (p=0.014). The following English translation of the original Japanese news release was provided by AnGes. Announcement of Results of Phase III Clinical Trials of HGF Gene Therapy in Japan AnGes conducted an interim analysis of the PIII data using HGF Gene (AMG 0001) for Critical Limb Ischemia (CLI) in Japan, and is pleased to announce that remarkable improvement was observed in the AMG0001 group compared with the Placebo group. Yesterday, an IDMC (Independent Data Monitoring Committee) was held, and now that the efficacy of AMG0001 is confirmed, the committee recommended to stop this trial in order to prevent potential ethical issues against the placebo group subjects. AnGes has accepted this advice today and decided to stop this trial. From now on, AnGes will closely communicate with governmental agencies and prepare for NDA filing. Outline of Study Results This trial is a randomized, placebo-controlled, double blind study for CLI subjects using AMG 0001. In this efficacy evaluation, 40 subjects with CLI were evaluated. 27 subjects received AMG0001, and were compared with 13 placebo subjects. (The AMG0001 group received 8mg (4mg x 2) of AMG0001.) The primary endpoints, which is, improvement of rest pain ((VAS (Visual Analog Scale)) or ischemic ulcer size, at 12 weeks post dosing, showed 30.8% improvement in Placebo group and 70.4% improvement in AMG0001 group and verified statistically significant difference (p=0.014) As for safety, 41 subjects (AMG0001: 28 subjects, Placebo: 13 subjects) were evaluated. Adverse drug reaction were equally distributed between AMG0001 group and placebo group. There were 8 SAEs in 6 subjects in the AMG0001 group (peripheral ischemia, cerebella infarction, post procedural hematoma, prostate cancer, bladder perforation, acute renal failure, peritonitis, bacterial pneumonia). However, causality due to AMG0001 was estimated none or low. In Placebo group, there were 4 SAEs in 3 subjects (2 embolism, toe gangrene, pain in thigh). All SAEs out of all studies using AMG0001 were evaluated by the DSMB (Data Safety Monitoring Board) and it was concluded that, as of today, there is no major safety concern related to AMG0001. While significant improvement was confirmed based on the efficacy evaluation, as AMG0001 is a highly novel therapeutic, AnGes will continue development by carefully following the safety. Snip Bernard

To: zeta1961 who wrote (1803)	6/18/2007 10:17:10 AM
From: Jibacoa	Read Replies (1) \| Respond to of 3722

Elizabeth, It seems that as usual,his information & deductions aren't good.<g> If you look at the BTK in the last few years, you will notice that in 1998; 09; 01; 03; 04; 05 & 06 the index performed well in the 2nd half of the year. (The results for 2007 are still pending.<g>) bigcharts.marketwatch.com The other deduction to make is that after it got off from the DT & found support in 2002-2003 at the 300 level. it has been on an UT that hasn't been broken yet. Just watch for the important support at the 700 level or if it will be able to make an all time H.<g> RAGL Bernard