Vical Incorporated (JOBS) Receives $2.3 Million Payment for Continued Funding of Allovectin-7(r) Phase 3 Trial
``We are making great progress recruiting patients as we continue to expand beyond North America to clinical sites across Western and Eastern Europe, into Israel, and recently into Turkey with the help of our commercialization partner Eczacibasi,'' said Vijay B. Samant, Vical's President and Chief Executive Officer. ``Including our sites in the United States and Canada, we expect to have more than 100 active clinical sites in key centers worldwide as we advance toward our final months of enrollment. Based on the trends across these regions, we are confident that we will complete enrollment in this pivotal Phase 3 trial by the end of the year.''
Vical is conducting the AIMM (Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma) Phase 3 pivotal trial targeting enrollment of approximately 375 patients with Stage III or IV metastatic melanoma. A patient self-screening tool for trial eligibility is available online at http://www.melanomaclinicaltrial.com.
Ei Yamada, AnGes' President and Chief Executive Officer, said, ``We are very pleased by the progress Vical has made to date and encouraged that they will be completing enrollment in the Allovectin-7(r) trial by the end of the year.'' In exchange for funding the trial, AnGes received exclusive marketing rights in Japan and other key Asian countries, and also will receive certain royalties for sales in the United States and European countries. AnGes is obligated to pay Vical royalties on product sales in the specified Asian countries, plus certain sales-based milestone payments if defined sales levels are achieved. Vical is obligated to pay AnGes tiered royalties based on defined sales levels in the United States, and fixed royalties on rest-of-world sales. Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7(r).
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.
The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768
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 Vical or others will continue development of Allovectin-7(r); whether Vical will be able to recruit patients into the AIMM trial as planned, if at all; whether Vical will receive all of the clinical trial funding from AnGes under the collaborative agreement, which will depend on continued development of Allovectin-7(r) and certain other conditions; whether Vical will receive any or all of the sales-based milestone payments and royalties for sales in the specified Asian countries, which will depend on the efforts of AnGes in obtaining regulatory approval and commercializing Allovectin-7(r) in those countries; whether any sales will be generated in the United States or Europe, which will depend on the efforts of Vical and potentially additional partners in obtaining regulatory approvals and commercializing Allovectin-7(r) in those regions; whether Allovectin-7(r) or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; whether defined sales levels will be achieved in any markets; 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.
Contact:
Vical Incorporated Alan R. Engbring (858) 646-1127 www.vical.com
Source: Vical Incorporated