FDA grants fast track designation to TH1902 for sortilin-expressing cancers
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The FDA granted fast track designation to TH1902 for treatment of certain patients with sortilin-expressing cancers, according to the agent’s manufacturer.
The designation applies to use of the agent as monotherapy for patients with recurrent, advanced solid tumors that are refractory to standard therapy.
TH1902 (Theratechnologies) is a peptide drug conjugate that combines the company’s proprietary peptide to docetaxel. The peptide targets sortilin (SORT1) receptors.
SORT1 is expressed in several malignancies, including ovarian, skin, lung, colorectal, pancreatic and triple-negative breast cancers.
“Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ technology and further supports the future development of TH1902,” Christian Marsolais, PhD, senior vice president and chief medical officer of Theratechnologies, said in a company-issued press release. “The designation, which applies to all solid tumors expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted and potentially more effective and better-tolerated therapies for cancer.”
A phase 1 trial expected to begin in the second quarter of this year will evaluate the safety, pharmacokinetics, maximum tolerated dose and preliminary antitumor activity of TH1902 dosed once every 3 weeks for patients with advanced solid tumors refractory to available therapies.
Once the maximum tolerated dose is established, investigators intend to enroll an additional 40 patients with endometrial, ovarian, colorectal, pancreatic or triple-negative breast cancers.
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