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Ascend to begin PhII trial for skin cancer

11 September 2014 | News | By BioSpectrum Bureau

Basal cell carcinoma is the most prevalent form of cancer in Australia, US and Europe

Basal cell carcinoma is the most prevalent form of cancer in Australia, US and Europe

Singapore: Ascend Biopharmaceuticals, a Melbourne-based immunotherapy company, plans to begin a Phase 2 clinical trial on ASN-002, an injectable immunotherapy for basal cell carcinoma (BCC), by H1 2015.

Ascend has also announced plans to begin a Phase 1b study on a therapeutic cancer vaccine for breast cancer, ASN-004, in the second half of 2015. Both trials are dependent on the completion of fundraising.

BCC is a type of non-melanoma skin cancer, diagnosed in an estimated two million people every year. It is the most prevalent form of cancer in Australia, the US and Europe. Although surgery is the primary treatment for BCC, surgery is an undesirable option for many patients for clinical or cosmetic reasons.

ASN-002 is a product based on an adenovirus (a type of cold-virus) that has been engineered to produce a powerful anti-cancer protein called Interferon. Ascend has secured an exclusive worldwide license to develop ASN-002 (formerly TG1042) from French biopharmaceutical company Transgene. Two clinical studies have already been completed in 51 patients with Lymphomas arising in the skin. These studies demonstrated that ASN-002 was safe, well tolerated and conferred highly favourable clinical responses.

"We are excited about evaluating ASN-002 in BCC patients. We believe this product has been de-risked by the previous clinical studies and there is a strong biological rationale for its use in BCC patients," Dr Clement Leong, CEO, Ascend. "In addition, we believe that the previous clinical results provide support for the use of ASN-002 in treating a number of other cancers with important medical needs, including lymphomas of the skin, melanomas and bladder cancers."

Ascend has also announced plans to begin a Phase 1b clinical study on its therapeutic cancer vaccine for breast cancer, ASN-004, in H2, 2015. Based on a product (OM-MUC-1) and platform originally developed at Melbourne's Burnet Institute, ASN-004 is an injectable treatment that creates a powerful immune response directed at attacking breast cancers.

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