India-based Piramal Pharma Limited's Pharma Solutions business announced on Monday that it is providing Canada-based Theratechnologies Inc (TSX: TH) (NASDAQ: THTX) with GMP manufacturing of sterile fill/finish drug product to support its developmental product, TH1902 Peptide-drug Conjugate, as the product commences its first-in-humans clinical study.
Piramal Pharma Solutions manufacturing site in Lexington, Kentucky is producing the clinical material that will be utilised in a Phase I TH1902 trial.
The Phase one trial design covers a dose escalation study to assess the safety, pharmacokinetics, maximum tolerated dose and preliminary anti-tumour activity of TH1902 administered once every three weeks in patients with advanced solid tumours refractory to available anti-cancer therapies.
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