Recently analyzed pharmacokinetic (PK) data from the first eight (8) patients enrolled in Sorrento Therapeutics‘ ongoing TRIBECA? Study (TRIal establishing BE between Cynviloq? and Albumin-bound paclitaxel) registrational trial shows positive results. Cynviloq, also known as IG-001 or Genexol-PM, is a novel nanoparticle formulation of paclitaxel.[1]
IG-001 and albumin-bound paclitaxel (Abraxane?; Celgene) appear to have similar biophysical characteristics and share a common mechanism of action. When given intravenously, both formulations are highly unstable in plasma and disintegrating rapidly to release paclitaxel into systemic circulation when given. In turn, released paclitaxel binds to albumin in the bloodstream where it forms albumin-paclitaxel complexes. These complexes are preferentially transported via the albumin-transport mechanism into the tumor tissues where paclitaxel – the cytotoxic drug – kills the tumor.
Clinical trial
The data from these patients supports earlier completion of the study with the aim of seeking to establish bioequivalence to albumin-bound paclitaxel to obtain Food and Drug Administration (U.S. FDA) marketing approval for IG-001. The study was designed to compare the pharmacokinetics of IG-001 and nab-paclitaxel in patients with metastatic or locally recurrent breast cancer. Patients meeting the eligibility criteria will be randomized to determine which drug is administered first.
…guided by the favorable pharmacokinetic data from actual patients treated we plans to reduce the TRIBECA patient sample size to accelerate filing for FDA approval…
Sorrento, the manufacturer of the trial drug, amended the current establish bioequivalence cross-over design protocol of the TRIBECA study to un-blind the first 8 patients to reassess the sample size of 100 patients estimated from simulation of historical pharmacokinetic data. Based on the cross-over data and the analyses of relevant paclitaxel plasma pharmacokinetic data performed by two independent pharmacokinetic consulting groups, the success of the bioequivalence approach for seeking approval of Cynviloq remains subject to FDA review and discussion. Sorrento does not plan to un-blind additional patient data. Current sample size point estimates suggest that the enrollment target for the current study can be reduced to nearly half of the original target.
“We are pleased that the favorable pharmacokinetic data from actual patients treated have thus far exceeded our expectations,” noted Henry Ji, PhD., President and Chief Executive Officer of Sorrento. “Guided by these promising data, Sorrento plans to reduce the TRIBECA patient sample size to accelerate filing for FDA approval.”
For more information:
[1] Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer (TRIBECA: NCT02064829) [Study Record Detail]
[2] Yardley DA. nab-Paclitaxel mechanisms of action and delivery J Control Release. 2013 Sep 28;170(3):365-72. doi: 10.1016/j.jconrel.2013.05.041. Epub 2013 Jun 1y.[Article][PubMed]
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