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Vical Incorporated Message Board

  • chart_surfer chart_surfer Nov 4, 2009 7:39 PM Flag

    Conspicuous silence on canine melanoma vaccine

    This is ominous. The canine melanoma vaccine is supposed to be approved by the end of the year, according to the previous earnings release. Complete silence on this issue. If it doesn't work on dogs, why should it work on people.

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    • And a more recent article:
      What You Should Know About Merial’s Melanoma Vaccine

      Posted on October 1, 2009

      In 2007, the USDA issued a conditional U.S. Veterinary Biological Product License for Merial’s canine melanoma vaccine. This is the first time the U.S. government has approved the use of a vaccine for the treatment of cancer (in animals or people). The research and production of the vaccine has been through a collaboration between The Animal Medical Center in New York City, Memorial Sloan Kettering Cancer Center, and Merial.

      How does the vaccine work? The melanoma vaccine is not a prophylactic vaccine to prevent development of the disease as we would normally think for traditional vaccines for infectious diseases. Instead, it is used as a mode of therapy after diagnosis of malignant melanoma and meant to be used in conjunction with other modes of therapy like surgery and radiation. The vaccine is made from a non-canine tyrosinase gene that is inserted into a plasmid vector. The vaccine is then injected into the patient via a Bioject transdermal injector. Tyrosinase is an enzyme found in melanoma and pigmented cells. In theory, the dog’s immune system is supposed to mount a response to the non-canine, foreign tyrosinase. Because tyrosinase across various species is similar to each other, cross-reactivity of the immune response occurs with the melanoma’s tyrosinase in the dog. This would allow the dog’s immune response to target the melanoma cells[1].

      So far, the few studies that have been published on the melanoma vaccine have shown increased survivals for dogs with advanced disease that received the vaccine when compared to historical controls. Older studies with traditional treatments with surgery, radiation, and chemotherapy have been associated with survival times of about 6 months for dogs with advanced disease. Survival times with vaccine therapy incorporated into the treatment regimen have been over a year for those with advanced disease[2]. The problem with comparing new treatment modalities with older, historical controls is the possibility of introducing bias to either of the two groups, raising the question of whether or not the comparison is appropriate.

      The melanoma vaccine is currently available through veterinary oncologists while it is under conditional licensure. See this month’s PowerPage for more on canine malignant melanoma.
      [1] Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine 2006;24:4582-4585.

      [2] Bergman PJ, et al. Long-Term Survival of Dogs with Advanced Malignant Melanoma after DNA Vaccination with Xenogeneic Human Tyrosinase: A Phase I Trial. Clinical Cancer Research 2003;9:1284-1290.

      Vaccine for Canine Oral Melanoma
      January 29, 2008 by travels

      The vaccine administered: One 0.4 ml dosage every two weeks for a total of four doses. 812 Afterwards, one booster dose administered every six months. 8 Regardless as to the size of the dog, the dosage remains the same. The (package) four -- vital packet sold to practitioners for $1,000. Markup price (profit margin) determine by the each practitioner. 12 Dr. Bob Nordgren, Ph.D., vice president of biologics research, development and technology acquisitions for Merial said: "the vaccine has yet to be formally named", because current licensing is conditional. After successful trial study of the vaccine, Merial evaluate breeds of dogs likely develop canine melanoma and direct a preventive vaccine treatment option.
      Vical Announces Licensee's Conditional Approval of Therapeutic Cancer Vaccine for Dogs
      Submitted by Armen Hareyan on Mar 26th, 2007

      Vical Incorporated (Nasdaq: VICL) today announced that its licensee Merial Limited, a joint venture of Merck & Co., Inc. and sanofi-aventis, received notification of conditional approval from the U.S. Department of Agriculture (USDA) to market a therapeutic DNA vaccine designed to treat melanoma, a serious form of cancer in dogs. The approval triggers a $0.2 million milestone payment to Vical. "Conditional approval" means the product has been shown to be safe and have a reasonable expectation of efficacy in treating melanoma. The designation allows Merial to market the therapeutic vaccine while collecting additional efficacy data to support full marketing approval.

      "This canine melanoma therapeutic DNA vaccine is the first companion animal product to receive conditional approval for our licensee Merial," said Vijay B. Samant, Vical's President and Chief Executive Officer, "which represents a significant advancement for our DNA delivery platform technology, building on the previous approval of a vaccine for farm-raised salmon for another of our licensees. Through our independent and partnered programs, we continue advancing toward initial approvals of DNA-based human health products for infectious diseases, cancer, and angiogenesis. We believe the progress of this DNA-based therapeutic vaccine for canine melanoma bodes well for DNA- based approaches for human melanoma. We are particularly encouraged by the prospects for our Allovectin-7(R) DNA-based immunotherapeutic for patients with metastatic melanoma."

      Melanoma is an aggressive form of cancer that commonly occurs in the dog's mouth, toes or footpads, and is virtually always malignant at these sites. Normal treatment for canine melanoma includes surgery, radiation, and combination chemotherapy, but even after successful treatment, the melanoma often recurs. Merial's melanoma therapeutic DNA vaccine is designed as an adjunct to treat melanoma in dogs.
      Source: Vical Incorporated

    • Merial was a joint venture between Merck and Sanofi, which now is owned 100% by Sanofi.

      Merial's canine melanoma (for dogs) got "conditional approval" in 2007:
      USDA Grants Conditional Approval for First Therapeutic Vaccine to Treat Cancer
      Merial's New Vaccine Treats Deadly Cancer in Dogs
      Duluth, Ga., March 26, 2007
      Canine melanoma is an aggressive form of cancer that typically appears in a dog's mouth, but also may appear in the nail bed, foot pad or other areas. Dogs with melanomas that have gone beyond initial stages typically have a lifespan of one to five months with conventional therapies. To date, the most common treatments for this form of cancer have been radiation and surgery. "Melanoma spreads readily, and, unfortunately, is often resistant to chemotherapy," said Bob Menardi, DVM, a veterinarian and spokesperson for Merial.
      Merial obtained licensing rights from MSKCC and AMC, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (Nasdaq: VICL), completed the industrialization and regulatory requirements for conditional licensure. The vaccine will be administered via a new Canine Transdermal Device, which delivers the vaccine without the use of a needle. The device was developed in conjunction with Bioject, a Portland-based research pharmaceutical device company (Nasdaq: BJCT).
      The USDA has issued a conditional U.S. Veterinary Biological Product License for this therapeutic vaccine. This conditional license is a response to an application and assurance of safety and purity, and a reasonable expectation of efficacy based on initial trials performed at MSKCC and AMC.
      During the period of conditional licensure, Merial will conduct additional research to further support the safety and efficacy of the vaccine. Production under this license is in compliance with all regulations and standards applicable to such products.

      Canine Melanoma Vaccine Gets Conditional OK
      By Marissa Heflin

      Because additional efficacy and safety research will be conducted during the conditional license period, Merial is making the vaccine available only to specialists practicing veterinary oncology, said Robert Menardi, DVM, technical marketing manager for Merial.

      And because the current licensing is conditional, he said, the vaccine has yet to be formally named.

      He said that the company intends for the vaccine to be available to a broader practice after the conditional license period.
      The canine melanoma vaccine is designed to be administered in an initial vaccination series of one 0.4 mL dose every two weeks for a total of four doses. Following the initial series, one booster dose is administered every six months.

    • Merial (canine melanoma therapeutic vaccine) was mentioned in last earnings Q2 2009 conference call.

      The impression then was VICL hasn't heard from Merial for a month, and that if it gets full approval "you will see ads" on local TV channels advertising it.

      Since VICL is a licensor, maybe they don't have that much say into what is done by Merial. If Merial starts selling it, then VICL will get a cheque.

      Though one would think the move from "conditional approval" to "full approval" would be public info.

      From Q1 2009 conference transcript
      May 7, 2009 12:00 pm ET
      We expect full approval of Merial's of melanoma vaccine for dogs. Everything is on track. The data is being submitted, so it's going to happen in just a matter of time. We expect AnGes, to at least make an announcement in terms of timing of the start of the trial.

      From Q2 2009 conference transcript
      August 6, 2009 12:00 pm ET

      Ren Benjamin – Rodman
      Okay. Just one final question. Milestones for the remainder of the year that as investors we should be looking out for and just any thoughts on – I think it was Merial that just got acquired by some other pharma?

      Vijay Samant
      No. It was a 50-50 joint venture between Merck and Sanofi and it's a part of the Sanofi Schering – Merck-ScheringPlough merger, Merck having some animal health – ScheringPlough having some animal business I think to prevent any intervention by FTC. They kind of sold their share of that animal health business to prevent any antitrust issues to Sanofi Pasteur. So Sanofi, which was a 50-50 owner, is now a 100% owner of Merial, okay?

      Ren Benjamin – Rodman

      Vijay Samant
      It was not acquired by any other company. We expect – to answer your question, we expect that in the next few months they – well, we have not heard recently in the last one month or so, but Merial or the – that animal health company is very optimistic of that drug getting full approval. And if that gets full approval, you will see ads in your local TV channel advertising – that product being advertised. As we told you, it's going to be priced at $1,000 per therapy.

    • You bring up a valid point...any other comments/insight from the longs?

      Seem to fell off the radar.

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