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[asics01]

Vical Licensee AnGes MG Files NDA in Japan for Collategene Angiogenesis Product
SAN DIEGO, March 28 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced the company's licensee, AnGes MG, Inc., reported submission on March 27, 2008, of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for its angiogenesis product candidate, Collategene, for treatment of critical limb ischemia. The treatment uses Vical technology to deliver a gene encoding hepatocyte growth factor (HGF), a human protein that causes growth of blood vessels in areas of restricted blood flow.

"The Japanese NDA filing positions Collategene to be the first product based on our DNA delivery technology with the potential to be approved for human use," said Vijay B. Samant, President and Chief Executive Officer of Vical. "In the United States, where it is estimated that more than 10 million people have peripheral arterial disease (PAD), AnGes already has completed two Phase 2 clinical trials of Collategene in PAD patients. This product candidate offers a novel approach to addressing an important, unserved medical need in the Japanese market, and has the potential to expand into the much larger markets worldwide. This NDA filing by AnGes is an important milestone in advancing nonviral gene therapy toward regulatory and commercial acceptance."

The NDA submission follows positive results announced in June 2007 following interim analysis of data from the first 41 subjects to complete a Phase 3 trial of Collategene. 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 recommended stopping the trial early to prevent potential ethical issues against the placebo group subjects.

In the trial, 40 subjects with critical limb ischemia (advanced peripheral arterial disease) were evaluated for efficacy. The primary endpoints, improvement of rest pain (Visual Analog Scale, or VAS) 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.

AnGes Submits NDA for HGF Gene TherapyAnGes MG, Inc.(TSE Mothers:4563, http://www.anges-mg.com) has submitted its New Drug Application (NDA) to MHLW (Japan) for HGF Gene Therapy (INN : beperminogene perplasmid, Brand Name : Collategene) to treat Critical Limb Ischemia (CLI) in Arteriosclerosis Obliterans (ASO) and Burger's disease, on March 27, 2008.

HGF Gene Therapy is a product, where a gene which induces HGF protein is injected to the ischemic lesion, leading to the formation of new blood vessels through the effect of the HGF protein, which results in improvement of the ischemic symptoms.

AnGes has developed this product for peripheral arterial diseases (ASO and Burger's Disease), which occurs by decreased blood flow caused by narrowing of blood vessels as a result of arteriosclerosis, and ischemic heart disease.

This is a product with a novel mechanism of action different from existing products, so that it may also be effective to patients in which existing therapeutics were not effective, or, surgical treatments can not be pursued. As for safety, we are using naked DNA delivery method instead of viral vectors to transfect genes, so that there won't be any safety concerns often caused by viral vectors in case of gene therapies.

HGF is a gene therapy product originally developed in Japan through the research at Academia, and development went ahead in Japan first.

Since last June, when we got the positive results at the interim analysis of our Phase III study in Japan for ASO patients with CLI, we have prepared for submission, and are pleased to be the first company in Japan to submit an NDA for a gene therapy product.

AnGes is aiming to provide this product to patients also worldwide. After approval, the brand name in Japan will be "Collategene". The name comes from the meaning of formation of "collateral vessels" by angiogenesis and improvement of ischemic symptoms by "gene therapy".

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. Forward-looking statements include statements about the potential approval of Collategene, as well as Vical's focus, collaborative partners, and product candidates. Risks and uncertainties include whether Collategene will be approved in Japan; whether AnGes will successfully expand into U.S. or worldwide markets with Collategene; whether gene therapy will gain regulatory and commercial acceptance; whether any product candidates under development by Vical or its collaborative partners will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market 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.

Contact: Alan R. Engbring

[phone]
Website: http://www.vical.com
SOURCE Vical Incorporated
03/28/2008
CONTACT: Alan R. Engbring of Vical Incorporated, [phone]/
Web site: http://www.vical.com
http://www.anges-mg.com
(VICL)

lest euch mal ein,ein wert mit potential (www.vical.com)
asics

[asics01]

Vical Receives Payment from AnGes MG for Allovectin-7(R) Phase 3 Pivotal Trial
SAN DIEGO, Jan. 17 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced the receipt of a $2.1 million cash payment from AnGes MG, Inc. for costs associated with the ongoing Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma (AIMM) Phase 3 trial.

AnGes is funding the Phase 3 pivotal trial of Allovectin-7(R) under a previously announced collaborative agreement through a scheduled series of cash payments and equity investments totaling $22.6 million, for which 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. Vical is conducting the trial in accordance with a Special Protocol Assessment (SPA) completed with the U.S. Food and Drug Administration (FDA).

The payment was triggered by utilization of previous cash balances, reflecting progress in the trial. The cash payment was received as anticipated in late December, and will be included in Vical's year-end 2007 cash balances, consistent with the company's guidance of a projected 2007 net cash burn of $27 million to $32 million. Revenue related to the cash payment will be deferred and matched to trial expenses as they are incurred.

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 Vical or others will continue development of Allovectin-7(R); whether Vical will be able to recruit patients 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: Alan R. Engbring

[phone]

Website: http://www.vical.com

SOURCE Vical Incorporated
01/17/2008
CONTACT: Alan R. Engbring of Vical Incorporated, [phone]
Web site: http://www.vical.com

[asics01]

vical ist doch ein top investment,was meint ihr???

asics

[asics01]

ist denn hier kein vicaler an bord ????

[asics01]

Vical Receives NIH Grant for an Immunotherapeutic Herpes DNA Vaccine; Herpes Experts at University of Washington and University of Texas to Conduct Preclinical Development
SAN DIEGO, April 3, 2008 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced that it has been awarded a two-year, $2.0 million Phase II Small Business Technology Transfer (STTR) grant from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. The grant will fund the ongoing development of Vical's immunotherapeutic plasmid DNA (pDNA) vaccine against herpes simplex virus type 2 (HSV-2), a sexually transmitted virus which is the leading cause of genital herpes. The HSV-2 vaccine will also be evaluated with Vical's novel Vaxfectin(R) adjuvant.

The initial preclinical development activities covered by the grant will be conducted at the University of Washington School of Medicine and the University of Texas Medical Branch, both centers of excellence in herpes virus research. The vaccine will be designed for use in people already infected with HSV-2, with the goal of reducing or eliminating periodic viral flare-ups and the associated viral shedding and transmission.

"HSV-2 infection is an important medical need affecting quality of life for tens of millions of people worldwide," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Chronic antiviral treatment carries a significant healthcare cost and contributes to the emergence of drug-resistant strains and increasing infection rates. A therapeutic vaccine that could control disease symptoms and transmission would be a welcome addition to the HSV-2 treatment arsenal. We are pleased to collaborate with leading academic research centers in addressing this critical public health need."

David Koelle, M.D., professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington School of Medicine, will lead the mouse research phase of the grant. He said, "I believe that technologies such as pDNA vaccines, which can contribute to priming and boosting CD8 T-cell responses to HSV-2, have the best chance of changing the natural history of established HSV-2 infection, potentially improving symptoms, lesions, shedding, and perhaps even transmission."

The $2.0 million Phase II STTR grant supplements the $0.3 million awarded to Vical in 2005 for the HSV-2 vaccine program under a Phase I STTR grant from the NIAID, which partially funded Vical's initial development of the HSV-2 vaccine.

About HSV-2

HSV-2 is a member of the herpesvirus family, and is the leading cause of genital herpes worldwide. In the United States, HSV-2 infects some 1.6 million people per year, with approximately 500,000 of those suffering from disease symptoms. At least 40 million people in the United States are infected with HSV-2. Even higher infection rates are evident in developing countries, with further complications in people also infected with HIV. All HSV-2 infections are permanent and result in periodic virus shedding.

There is currently no approved vaccine for HSV-2. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost over the years and potential for drug resistance further underscore the need for safe, new approaches to reducing HSV-2 lesions, shedding, and transmission.

Estimated costs of treating HSV-2 in the United States alone are close to $1 billion, primarily for drugs and outpatient medical care. Additional indirect costs from HSV-2 infection, such as lost work hours, are more than $200 million annually in the United States.

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 all funding under the grant will be received by the company; whether the development efforts will result in a vaccine that can generate T-cell and antibody immune responses sufficient to reduce or eliminate periodic viral flare-ups and the associated viral shedding and transmission; whether the Vaxfectin(R) adjuvant will effectively enhance the performance of the HSV-2 vaccine; 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; 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: Alan R. Engbring
[phone]
Website: http://www.vical.com

SOURCE Vical Incorporated
CONTACT: Alan R. Engbring of Vical Incorporated, [phone]
Web site: http://www.vical.com


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[Pipifax]

Antwort auf Beitrag Nr.: 33.803.799 von asics01 am 03.04.08 20:57:02

Ich kenne Vical von Genetronics, jetzt Inovio her.
Vical arbeitet mit deren Technik.

[asics01]

Antwort auf Beitrag Nr.: 33.837.130 von Pipifax am 08.04.08 16:02:44

und wie ist deine meinung zu diesem laden???

asics

[Pipifax]

Antwort auf Beitrag Nr.: 33.837.173 von asics01 am 08.04.08 16:06:04

Zukunftsträchtig.
Wenn sich die Horden von Bullen, Kühen und Ochsen im Rohstoffmarkt ausgetobt haben, werden sie sich woanders umsehen.
Irgendwann wird das Segment der Biotechs wiederentdeckt werden.
Wohl dem, der vorausschauend zu Tiefstkursen eingekauft hat.

Gruß
Pipifax

[Pipifax]

Antwort auf Beitrag Nr.: 33.837.173 von asics01 am 08.04.08 16:06:04

http://ir.inovio.com/phoenix.zhtml?c=105128&p=irol-newsArtic…

State of the Art in delivery of DNA vaccine?

[asics01]

Antwort auf Beitrag Nr.: 33.842.393 von Pipifax am 09.04.08 09:02:39

richtig,die bios werden wieder auferstehen und ich bin dabei.bist du in inovio und vical investiert???

asics

[Pipifax]

Antwort auf Beitrag Nr.: 33.849.637 von asics01 am 09.04.08 19:42:42

Ja, seit ein paar Jahren schon. Überwiegend aber in Inovio, weil ich glaube hier ist das Risiko nicht so hoch, wegen der vielen unterschiedlichen Trials mit DNA-Impfstoffentwicklern.
Ich spekuliere auf einen Durchbruch beim neuartigen, DNA-basierten Impfstoffen. Wenn da eines Tages - egal von welcher Firma - echte überzeugende Meldungen kommen, dann gibt das einen gewaltigen Schub für das gesamte Biotechsegment.