Loxo Oncology, Inc.
LOXO, a biopharmaceutical company focused on the discovery,
development, and commercialization of targeted cancer therapies, today
announced the presentation of initial Phase 1a safety and pharmacokinetic data
for LOXO-101, the only selective inhibitor of the TRK family of tyrosine
kinase receptors in clinical development, in a poster session at the American
Association for Cancer Research (AACR) 2015 Annual Meeting in Philadelphia,
PA. The poster, entitled "Pharmacokinetics (PK) of LOXO-101 during the
first-in-human Phase I study in patients with advanced solid tumors: Interim
update," will be presented in the Experimental and Molecular Therapeutics
session today from 1:00 PM - 5:00 PM ET in poster section 32. The poster is
also available at www.loxooncology.com.
"We are very pleased with the initial clinical data for LOXO-101 and are
excited about the drug's pharmacokinetics so far," said Jennifer Low, M.D.,
Ph.D., Chief Medical Officer of Loxo Oncology. "LOXO-101 has been well
tolerated with systemic exposures that exceed our preclinical predictions for
these dose cohorts. At doses tested thus far, drug levels of LOXO-101 are
already at biologically relevant concentrations and support the therapeutic
potential of this highly selective inhibitor of TRKA, TRKB, and TRKC. We look
forward to turning our focus towards TRK-altered patients."
Key findings from the poster presentation include:
* As of the data cut-off for the poster, March 26, 2015, 15 patients have
been enrolled across three dose cohorts: 50mg QD (n=4), 100mg QD (n=5),
and 100mg BID (n=6), including one soft tissue sarcoma patient with an
NTRK1 fusion enrolled on March 10, 2015
* Pharmacokinetics show good systemic exposure of LOXO-101 after oral
dosing, with higher exposures observed than those predicted in nonclinical
studies
* LOXO-101 was generally well tolerated with the most common adverse events
being Grade 1 and 2 fatigue, dizziness and anemia; no study drug related
serious adverse events (SAEs) have been reported; the maximum tolerated
dose (MTD) has not yet been reached.
In the second half of 2015, Loxo will provide an update on its clinical
development plans for LOXO-101.
LOXO-101 was developed in collaboration with Array BioPharma.
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