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Kura Oncology begins dosing in Phase II tipifarnib trial to treat tumors with HRAS mutations

US-based biopharmaceutical firm Kura Oncology has started dosing in the Phase II clinical trial of tipifarnib in patients with locally advanced tumors that carry HRAS mutations.

Tipifarnib is an inhibitor of farnesylation, a major cell signaling process implicated in cancer initiation and development.

The HRAS protein is involved in regulating cell division in response to growth factor stimulation and other signals that instruct cells to grow or divide.

HRAS is an early player in many signal transduction pathways and acts as a molecular on/off switch and once turned on, it recruits and activates proteins necessary for the propagation of the signal.

Memorial Sloan Kettering Cancer Center medical oncologist and Phase II trial lead investigator Alan Ho said: "There are no approved treatments that target HRAS mutations specifically."

Kura Oncology chief medical officer Antonio Gualberto said: "Tipifarnib has previously demonstrated durable responses in subsets of patients with cancer.

"The selection of patients with tumors characterized by HRAS mutations represents a promising strategy to identify those patients most likely to benefit from tipifarnib."

In the trial, a total of 36 patients will be enrolled into two non-randomized groups: malignant thyroid tumors with HRAS mutations; and non-hematological malignancies with HRAS mutations.

The trial’s primary objective will be to investigate the antitumor activity, in terms of objective response rate, of tipifarnib in patients with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations.

Secondary objectives of the trial will include evaluation of progression-free survival, duration of response and safety.