Navigation Links
Vical Licensee Sanofi-aventis Initiates Phase 3 Trial to Reduce Amputations
Date:9/20/2007

SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis, a licensee of Vical Incorporated (Nasdaq: VICL), announced on Monday the initiation of a 500-patient Phase 3 clinical trial of its NV1FGF angiogenesis therapy, which is based on Vical's non-viral DNA delivery technology. Assuming successful completion of the trial, called TAMARIS, sanofi-aventis expects to file for marketing approval in 2010.

The plasmid DNA (pDNA) therapy encodes Fibroblast Growth Factor 1 (FGF-1), a growth factor that stimulates the growth of blood vessels, and is intended to reduce the need for amputations in patients suffering from critical limb ischemia. Sanofi-aventis previously reported results from a Phase 2 trial in 107 patients demonstrating a statistically significant reduction in the rate of both major amputations and all amputations in patients receiving NV1FGF compared with those receiving placebo.

"In addition to DNA vaccines for infectious diseases and cancer, angiogenesis is among the most promising applications of our DNA delivery technology," said Vijay B. Samant, Vical's President and Chief Executive Officer. "The ability of pDNA to induce production of a protein locally at the site of injection ideally matches the desired treatment profile for critical limb ischemia, and perhaps for earlier stages of peripheral vascular disease. We are pleased that sanofi-aventis, one of our two partners in this field, has advanced into Phase 3 testing of this novel therapy addressing a major unmet medical need, and we look forward to successful completion of the trial."

The TAMARIS study is a double-blind, placebo-controlled Phase 3 trial in approximately 500 patients with critical limb ischemia. Four doses of 4 mg each will be administered by intramuscular injection at two-week intervals, and follow-up will continue for one year. The primary endpoint is the prevention of major amputation or of death. Additional information on the trial is available at http://en.sanofi-aventis.com/index.asp.

About Critical Limb Ischemia

Critical limb ischemia is a severe and costly condition. In the twelve months following the first episode of critical limb ischemia, 55% of patients either require amputation or die. In the United States and Europe, there are more than 150,000 amputations each year due to critical limb ischemia, with a direct cost of nearly $6 billion and a total cost of more than $8 billion. No disease-modifying therapy for critical limb ischemia is currently available.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at http://www.vical.com.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether sanofi-aventis will continue development of NV1FGF as planned; whether NV1FGF or any other product candidates will be shown to be safe and effective in clinical trials; whether Phase 3 trial results will support filing for marketing approval by 2010, if at all; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market NV1FGF or any other product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

Contacts: Investors: Media:

Alan R. Engbring Susan Neath

Vical Incorporated Porter Novelli Life Sciences

(858) 646-1127 (619) 849-6007

Website: http://www.vical.com


'/>"/>
SOURCE Vical Incorporated
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Vaccine Can Prevent Cervical Cancer and Precancerous Lesions
2. Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix Provides Excellent Protection Against Lesions Caused by Most Common Cancer-Causing Virus Types
3. Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis Trial in Japan
4. Vical Interim Clinical Results Demonstrate Safety and Tolerability of Inovio Biomedicals Electroporation DNA Delivery Technology
5. Cervarix, the GSK Cervical Cancer Candidate Vaccine, Provides Sustained Immune Response in 100 Percent of Women up to 55 Years of Age
6. Vicals Vaxfectin Adjuvant With Needle-free Delivery Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation Without Tolerability Issues
7. New England Journal of Medicine Publishes New Data on Gardasil, Mercks Cervical Cancer Vaccine
8. Cervarix, GSK Cervical Cancer Candidate Vaccine, Demonstrates 100 Percent Protection Against Precancerous Lesions Caused By Cancer-Causing Human Papillomavirus Types 16 & 18 for More Than Five Years
9. Vicals Vaxfectin Adjuvant Achieves Dose-Sparing Effect With Seasonal Influenza Vaccine
10. Nventa Announces Presentation of Positive HspE7 Data from NCI-Sponsored Clinical Trial in Cervical Dysplasia
11. Geron Corp. Licensee TA Sciences Announces Landmark 7/07/07 Teleconference to Answer Questions About TA-65, Their Telomerase Activator With Proven Age Management Benefits
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... Calif. , Feb. 5, 2016  Syneron ... global aesthetic device company, announced today that ... Candela North America, is scheduled to participate in ... Healthcare Conference on February 11, 2016 in ... will allow institutional investors to meet with the ...
(Date:2/5/2016)...  Aralez Pharmaceuticals Inc. ("Aralez") today announced the completion ... Pharmaceuticals Canada Inc. ("Tribute") following approval of the transaction ... combined company will operate under Aralez Pharmaceuticals Inc. ("Aralez"), ... Canada , Ireland ... the terms of the Agreement and Plan of Merger ...
(Date:2/5/2016)... --> --> ... the global active pharmaceuticals ingredients (APIs) market stood at ... US$185.9 bn by 2020. It is expected to expand ... The title of the report is "Active Pharmaceutical Ingredients ... by Therapeutic Area) - Global Industry Analysis, Size, Share, ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior TV show, ... much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will stream on ... week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food Warriors - ...
(Date:2/5/2016)... ... February 05, 2016 , ... The event is being held on April ... in Minneapolis, Minn. Triumph Over Parkinson’s will fund nearly $100,000 for research for the ... lives with Parkinson’s disease and is the architect of this informative event to raise ...
(Date:2/5/2016)... ... February 05, 2016 , ... Francisco Canales, ... services in their Napa Valley office. The technique utilizes the body’s own healing ... Canales and Dr. Furnas, are part of only a select few cosmetic surgeons ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... President George H. Van Allen have signed a joint enrollment and degree completion ... seamless pathway toward associate and baccalaureate degrees at FHU|Dickson. , The agreement ...
(Date:2/5/2016)... ... February 05, 2016 , ... The Lymphoma ... innovative lymphoma research and serving the lymphoma community through a comprehensive series of ... host, Swirl, A Wine Tasting Event at the La Gorce Country Club in ...
Breaking Medicine News(10 mins):