Intas Pharma Gets CDSCO Panel Nod to Study anti-cancer Drug Lipid Based Cabazitaxel
New Delhi: Citing that the firm should include an adequate number of government hospital trial sites, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major Intas Pharmaceutical to conduct the Phase II clinical trial of the anti-cancer drug Lipid Based Cabazitaxel Tablet 50mg.
However, this approval is subject to the condition that Intas Pharmaceutical should include an adequate number of government hospital trial sites.
This came after Intas Pharma presented Phase-I clinical trial report of Lipid-Based Cabazitaxel Tablet 50mg along with Phase-II clinical trial protocol (Protocol No. 0128-23 Version No.1.1 Dated: 16.09.2023) before the committee.
Cabazitaxel is an antineoplastic agent used in combination with corticosteroids to treat metastatic castration-resistant prostate cancer in patients previously treated with a docetaxel-containing treatment regimen.
Cabazitaxel is a taxoid synthesized from 10-deacetylbaccatin III, a compound isolated from the yew tree. As a second-generation semisynthetic microtubule inhibitor, cabazitaxel stabilizes microtubules and induces tumor cell death. Due to its low affinity for the P-glycoprotein (P-gp) efflux pump, cabazitaxel can more readily penetrate the blood-brain barrier compared to other taxanes like paclitaxel and docetaxel.
Cabazitaxel is used to treat metastatic castration-resistant prostate cancer.
Cabazitaxel is indicated, in combination with prednisone, for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. In Europe and Canada, it can also be used in combination with prednisolone.
Cabazitaxel binds to the N-terminal amino acids of the beta-tubulin subunit and promotes microtubule polymerization while simultaneously inhibiting disassembly: this results in the stabilization of microtubules, preventing microtubule cell division. Cabazitaxel ultimately blocks mitotic and interphase cellular functions and tumor proliferation.
At the recent SEC meeting for oncology held on the 9th and 10th of January 2024, the expert panel reviewed the Phase -1 clinical trial report of Lipid-Based Cabazitaxel Tablet 50mg along with Phase-II clinical trial protocol(Protocol No. 0128-23 Version No.1.1Dated: 16.09.2023).
After detailed deliberation, the committee recommended a grant of permission to conduct a Phase-II clinical trial of Lipid-Based on the Cabazitaxel tablet 50mg as per protocol presented by the firm, subject to the condition that the firm should include an adequate number of government hospital trial sites.
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