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Merck KGaA starts third phase III trial for cancer hope TH-302

Unique method of action to target cells with low oxygen levels

Merck KGaA has started a phase III trial of its novel cancer candidate TH-302 in patients with locally advanced or metastatic pancreatic adenocarcinoma.

Merck licensed TH-302 from US company Threshold Pharmaceuticals in a $750m deal last year after encouraging results in a phase IIb study, and is also conducting phase III trials of the drug in soft tissue sarcoma and advanced pancreatic cancer.

TH-302 takes a completely different tack to other cancer drugs because it is designed to release its cell-killing payload only when it encounters low oxygen (hypoxic) conditions in the body, such as the interior of tumours.

The activated drug will also diffuse into more oxygenated areas of the tumour - killing cells via a process known as the bystander effect - but theoretically at least should spare healthy, oxygen-rich tissues from harm.

The new phase III trial -called MAESTRO - aims to enrol 600 patients and will compare TH-302 plus gemcitabine to gemcitabine alone in previously-untreated pancreatic adenocarcinoma, with overall survival as the primary endpoint.

"Patients with advanced pancreatic cancer currently have a poor prognosis and limited treatment options," commented Eric Van Cutsem of the University Hospitals in Leuven, Belgium, who is the coordinating investigator for MAESTRO.

"Tumour hypoxia is thought to be a factor that makes pancreatic cancer particularly difficult to treat," he added.

The phase IIb study reported last year showed that in patients with advanced pancreatic cancer TH-302 and gemcitabine was able to increase progression-free survival (PFS) by almost two months, meeting its primary objective.

Analysts at Bryan, Garnier & Co said last year that TH-302 is "one of the most exciting compounds in development at Merck", with peak sales potential of €2bn in 2020, providing the firm can secure approval in both pancreatic cancer and soft tissue sarcoma.

25th January 2013

From: Research

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