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Loxo Oncology begins Phase I study of TRK inhibitor

US-based Loxo Oncology has begun a Phase I clinical trial of its LOXO-101, a potent and selective inhibitor of the tropomyosin kinase (TRK) family of receptors.

The Phase 1 study has been designed to assess the safety, pharmacokinetics and pharmacodynamics of escalating doses of LOXO-101. In a second stage, it will also provide a preliminary assessment of anti-tumor activity in cancer patients preselected to have an alteration in genes affecting the TRKA, TRKB or TRKC proteins.

Loxo Oncology chief medical officer Dr Lori A Kunkel noted that the company is very excited to begin the clinical evaluation of LOXO-101, which has been specifically designed to block TRK signaling.

"Increasingly, TRK alterations are being described across human cancer, and in many cases, alongside known, validated oncogenes in a range of malignancies, including lung cancer, thyroid and neural crest-derived tumors. We believe these patients need more specific and effective treatments," Kunkel added.

Loxo Oncology CEO and president Dr Josh Bilenker noted that the advancement of LOXO-101 into the clinic is an important milestone for the company.

"It exemplifies our approach to targeted drug development – the application of compelling chemistry to a promising target in a genetically-defined patient population," Dr Bilenker added.

"We look forward to working with patients and key thought leaders to evaluate the potential of this and other exciting developmental therapeutics," Dr Bilenker added.

According to Loxo Oncology, the company retains all development and commercialization rights to its TRK inhibitor program that includes its lead candidate LOXO-101.