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Phase II Clinical Trial Of MVA-HPV-IL2 Initiated.(Brief Article)

Vaccine Weekly

| December 19, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2001 DEC 19 - (NewsRx.com & NewsRx.net) -- Transgene (TRGNY) announced the initiation of a Phase II clinical trial of its immunotherapeutic MVA-HPV-IL2 product candidate for the treatment of cervical cancer.

The trial will be conducted in Mexico and will include up to 57 women with varying stages of HPV 16 cervical cancer, each of whose cancer either is resistant to radiotherapy or has recurred after radiotherapy.

The Phase II clinical trial will be conducted at two sites in Mexico (Monterrey and Mexico City) and will evaluate the efficacy of multiple subcutaneous injections. The trial will be performed according an optimized design divided into two stages. The first stage will involve an interim analysis performed once 22 evaluable patients have been reviewed at six months post-treatment. If at least five patients respond to treatment in the first stage, the study will recruit 35 additional patients for a second stage of product candidate evaluation.

"We believe that immunotherapy could be used to successfully treat cervical cancer by inducing an immune response against HPV 16, the virus responsible for cervical cancer," said Gilles Belanger, Transgene. "This is an important step forward in the development of our HPV program. After collecting very encouraging data from the Phase I clinical trial of this product candidate, we're excited about the possibility of addressing the large unmet medical need for patients suffering from cervical cancer."

Transgene's MVA-HPV-IL2 product candidate uses the MVA virus to express two HPV antigens found in HPV 16, the E6 and E7 proteins. The new generation MVA vector is a highly attenuated pox virus that combines the advantages of a strain ...

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