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Subject: "New life for Xenova DISC-HSV? something to look into..." Archived thread - Read only
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Conferences Herpes News Topic #1084
Reading Topic #1084
Apr-26-06, 01:10 AM (CST)
"New life for Xenova DISC-HSV? something to look into..."

Oxxon Therapeutics Licenses Rights to Xenova's DISC-HSV and DISC-GM-CSF Vector Technologies

13th January 2005, Boston MA (US)
Oxxon Therapeutics, Inc. announced today that Oxxon has licensed exclusive worldwide rights to Xenova Group's plc (NASDAQ: XNVA and London Stock Exchange: XEN) DISC-HSV and DISC-GM-CSF vector platforms for use in developing products for certain major cancers and chronic infectious diseases. DISC-GM-CSF, used as a stand-alone product, has been tested in a number of oncology indications including a dose-ranging Phase I trial for melanoma.

The agreement covers exclusive use of DISC-HSV and DISC-GM-CSF for preventative as well as therapeutic products in select conditions and options to obtain rights to additional indications. The agreement includes the vectors' use both as part of priming and boosting regimens or as stand-alone products. Under the terms of the agreement, Xenova will receive a staged up-front fee, milestones and royalties on sales of products.

"Oxxon is building an immunotherapeutic pipeline through its proprietary PrimeBoost approach, a strategy that delivers disease antigens with two different, non-replicating vectors," said Deirdre Gillespie, M.D., president and chief executive officer of Oxxon. "DISC-HSV and DISC-GM-CSF provide Oxxon with new, versatile antigen delivery platforms that we can incorporate rapidly in new product candidates. Both vectors have produced potent immune responses in a number of models and have been demonstrated to be safe in humans. In addition, Xenova has developed an advanced manufacturing process for them."

Oxxon's current pipeline includes clinical-stage programs for melanoma, hepatitis B, and a late stage pre-clinical immunotherapeutic for HIV.

DISC-HSV Vector Platform
The DISC-HSV (Disabled Infectious Single Cycle - Herpes Simplex Virus) Vector platform was designed for the safe delivery of heterologous antigens to the immune system in order to stimulate a comprehensive range of immunological responses, including helper and cytotoxic T cell responses. The virus is genetically inactivated through the deletion of a single gene from the genome that is essential for the reproduction of the virus.

The DISC-HSV vector has a number of features, which may offer significant advantages over alternative vector systems. These include the ability to target cell types for which other vectors have proved unsatisfactory and the capacity to carry and deliver large amounts of foreign DNA.

In addition, these vectors combine the immunological advantages of conventional live-virus vaccines with the safety normally associated with chemically inactivated or subunit vaccines. DISC-HSV vectors also have the potential to generate effective immune responses after direct administration to mucosal surfaces, which may be an important element of protection against pathogens that enter the body at those sites.

These characteristics, coupled with the inability of the DISC-HSV vector to replicate within the body and its excellent safety profile, demonstrated in extensive pre-clinical and clinical trials of DISC-HSV as a vaccine, indicate that the DISC-HSV vector has considerable potential for the development of a number of new product opportunities.

DISC-GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) is an immunotherapy product that uses the DISC-HSV Vector to deliver the GM-CSF gene to tumor cells. GM-CSF is a cytokine and a potent stimulator of immune responses. DISC-GM-CSF has broad potential for use across a wide range of solid tumor types.

In pre-clinical studies, DISC-GM-CSF was shown to be effective in models of breast, renal and colorectal cancer. The product was capable of inducing regression when injected directly into these tumors in vivo, and this regression was mediated by the induction of an anti-tumor immune response.

A Phase I dose-escalating safety study was completed at three centers in the UK in patients with metastatic melanoma. DISC-GM-CSF was found to be well tolerated, with no serious adverse events reported. Following injection it was not possible to retrieve DISC-GM-CSF from either the injection site or from the patients' serum, showing that the DISC-HSV vector was localized and had not spread beyond the required therapeutic area.

About Oxxon Therapeutics, Inc.
Oxxon Therapeutics, Inc. (Oxxon) is advancing the next generation of innovative immunotherapies to treat patients with chronic infectious diseases and cancer. To date, the company has built a pipeline through its proprietary PrimeBoost platform, an approach that allows the rapid development of products to selectively stimulate and enhance a potent cellular immune response. The company has five development programs in hepatitis, melanoma and HIV, two of which are in Phase II clinical trials. In addition, the company is leveraging its enabling platform through partnerships with companies and academic collaborations.

About Xenova Group plc
Xenova Group plc is a UK-based biopharmaceutical company focused on the development of novel drugs to treat cancer and addiction with a secondary focus in immunotherapy. The Company has a broad pipeline of products in clinical development, including three cancer programs: its lead product TransMID TM , for the treatment of high-grade glioma, is in Phase III trials, and its novel DNA targeting agents and XR303 are both in Phase I for cancer indications. Xenova is also developing two therapeutic vaccines for cocaine and nicotine addiction, which are in Phase II and Phase I trials respectively. Quoted on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately 75 people throughout its sites in the UK and North America. (Reuters XEN.L; Bloomberg XEN LN)

For further information, please contact:
Deirdre Gillespie, M.D.
President & Chief Executive Officer
Oxxon Therapeutics, Inc.

Feinstein Kean Healthcare
Barbara Askjaer

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