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:1/23/2017)... InDex Pharmaceuticals Holding AB (publ) today announced ... of the European Crohn,s and Colitis Organisation (ECCO). The ECCO congress ... on inflammatory bowel disease (IBD). The congress is held in ... ... again having been selected to present data at the largest IBD ...
(Date:1/23/2017)... 23, 2017 Just two weeks remain until legal experts and ... in Central London to discuss the flow of ... the market, Parallel Trade 2017 . In the run ... attendees which is available to read in the event download centre ... Some of those ...
(Date:1/22/2017)... ABU DHABI , Saudi Arabia , January ... the US and UAE ... of the Future , at the World Economic Forum   ... future will be driven by big data and powered by artificial intelligence and ... of experts that discussed the ,Hospital of the Future, at the concluding day ...
Breaking Medicine Technology:
(Date:1/23/2017)... ... January 23, 2017 , ... Valentine’s Day is a time when many people celebrate romance ... those who may be looking for the ideal present, Atlanta-based Perimeter Plastic Surgery ... additional $25 free. Or, spend $200 and get $50 free. , “A lot of ...
(Date:1/22/2017)... SAINT- MALO, FRANCE (PRWEB) , ... January 22, 2017 , ... ... the Indian Ocean, isolated from the rest of the world with ZANZIBAR MILKY CREAM. ... Africa, Phytocéane used key ingredients like Virgin Coconut Oil and moisturizing vegetal coral to ...
(Date:1/22/2017)... ... January 22, 2017 , ... Zifam Pinnacle, an Australian ... world, recently met with big-name retail buyers at the January ECRM Trade Show in ... and uses the utmost safety standards in all of its creations to help create ...
(Date:1/22/2017)... ... January 22, 2017 , ... "Photo Cloud allows FCPX users to add ... slideshow with complete ease," said Christina Austin - CEO of Pixel Film Studios. ... FCPX timeline. Presets include scenes with one, three, four or five focus ...
(Date:1/22/2017)... ... , ... Medical lab testing through hospitals and other traditional methods ... will take days to arrive to the end customer, having to travel through medical ... lab tests, bypassing the cost and delay of traditional means. Now all employees of ...
Breaking Medicine News(10 mins):