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news.Infinity Pharmaceuticals, a drug discovery and development company, has commenced a randomized, placebo-controlled Phase 2 trial to evaluate retaspimycin hydrochloride (HCl) (IPI-504) in conjuction with docetaxel (Taxotere) in non-small cell lung cancer (NSCLC) patients.
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The Phase 2 trial will assess the anti-tumor activity, tolerability and safety of retaspimycin HCl in combination with docetaxel as compared to docetaxel alone in approximately 100 second- or third-line NSCLC patients who are naive to docetaxel treatment.
The results from Phase 1b trial suggested that retaspimycin HCl in combination with docetaxel was well-tolerated and demonstrated clinical activity in NSCLC patients with poor prognoses, including patients with squamous cell carcinoma or with a history of heavy smoking.
Currently, Infinity intends to start a second clinical trial of retaspimycin HCl in patients with NSCLC by this summer.
Infinity chief medical officer Pedro Santabarbara said they are encouraged by the results seen in their Phase 1b trial, where response rates in NSCLC patients with a poor prognosis and limited treatment options were among the highest seen to date.
"These clinical results suggest that retaspimycin HCl may provide an important therapeutic benefit in specific forms of NSCLC when used as part of combination therapy," Santabarbara said.