SwitzerlandSwitzerland

Roche provides details on vismodegib proof-of-concept in advanced skin cancer

21.06.2011

Basel/Nantes – Roche has presented details of its clinical Phase II proof-of-concept study with its sonic hedgehog pathway blocker vismodegib (RG3616/GDC-0449) on patients with advanced basal cell carcinoma. The single-arm, two-cohort, open-label study enrolled 104 patients with advanced BCC, including laBCC and mBCC. The 71 laBCC patients had lesions that were inappropriate for surgery (inoperable, or for whom surgery would result in substantial deformity) and for which radiotherapy was unsuccessful or contraindicated. mBCC (33 patients) was defined as BCC that had spread to other parts of the body, including the lymph nodes, lung, bones and/or internal organs. Study participants received 150mg vismodegib orally, once daily until disease progression or intolerable toxicity. Overall response rate was 43 percent in the laBCC cohort, and 30 percent in the mBCC group. Progression-free survival (PFS) for both metastatic and locally advanced BCC patients was 9.5 months. The clinical benefit rate – defined as patients who experienced response as well as prolonged stable disease for more than 24 weeks – showed vismodegib shrank tumours or healed visible lesions, or prevented them from growing any further in 75 percent of patients. As announced in March, the most common adverse events included muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhoea. Serious adverse events (SAEs) were observed in 25 percent of patients, but only 4 percent were considered to be related to treatment with vismodegib. Fatal events were reported in 7 percent of patients but none were considered by investigators to be related to treatment with vismodegib. In all cases, patients had other pre-existing diseases or symptoms that were related to their presumed cause of death. Vismodegib was developed by Roche in collaboration with Curis Inc. for BCC, colorectal cancer and medulloblastoma, all of which show activation of sonic hedgehog signalling.

SwitzerlandSwitzerland

30.03.2012

Basel/Hinxton (UK) – Two European teams have created huge repositories of cancer genomics data that help predict drug response. Swiss Novartis and the Boston-based Broad Institute have combined data obtained from large-scale...

SwitzerlandSwitzerland

27.03.2012

London/Lausanne – The global private equity firm Celtic Therapeutic L.L.L.P. believes in the power of antibody-drug conjugates (ADCs). It is investing $50m in a new Switzerland-based company called ADC Therapeutics Sarl which...

SwitzerlandSwitzerland

26.03.2012

Basel/Vienna - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer. Roche said subcutaneous...

SwitzerlandSwitzerland

09.03.2012

After the US Food & Drug Administration forced Swiss generics giant Sandoz AG to update its production facilities in Quebec, there are now fears that supplies of some medicines could grow tight in Canada. The regulatory authority...

SwitzerlandSwitzerland

08.03.2012

The hepatitis C space has seen a string of large deals in the last weeks that include a US$11bn buyout of Pharmasset by Gilead. Now Novartis is also trying to get in the game with the purchase of a global exclusive licence from...

SwitzerlandSwitzerland

06.03.2012

Allschwil – Swiss Actelion Ltd. has strengthened its commercial offerings by securing rights in certain countries to Auxilium’s biotech drug Xiaflex for treating tissue buildup under the skin. The US pharma is to receive US$10m...

SwitzerlandSwitzerland

06.03.2012

Zug – Life Sciences specialist HBM partners has raised €90m in the first close of its HBM BioCapital II fund, which will invest in revenue-generating companies in the pharmaceuticals, medical device and diagnostics sectors....

SwitzerlandSwitzerland

05.03.2012

Stans – Mondobiotech, a drug discovery company in troubled waters, could soon be under Italian ownership: The Swiss biotech announced it has entered into exclusive negotiations with Milan-based provider of pharmaceutical and...

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