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2021-11-27| Trials & Approvals

Starpharma Announces Encouraging Interim Results for Prostate Cancer Drug

by Rajaneesh K. Gopinath
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Starpharma is a leading Australian company that develops new pharmaceutical and medical products based on polymers called dendrimers. As a leading company in this field, its proprietary drug delivery platform, DEP, is being used to improve drugs by reducing toxicity and enhancing their performance.

On November 26th, the Melbourne-based biotech announced positive interim results from an ongoing Phase 2 trial that evaluated its DEP cabazitaxel in prostate cancer patients. Data showed that 100% of evaluable patients with (Stage IV) metastatic prostate cancer have had efficacy responses by employing one or more standard measures of the disease.

“The trial results to date for DEP cabazitaxel in heavily pre-treated prostate cancer patients are highly encouraging and indicate the potential of the product compared to standard cabazitaxel,” said Professor Anthony Joshua, Study Investigator from the Kinghorn Cancer Centre in Sydney.

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Detergent Free, Nanoparticle Version of Jevtana

Prostate cancer is the second most common cancer in men, with 1.4 million new prostate cancer patients diagnosed annually. The five-year survival rate for metastatic castration-resistant prostate cancer patients is approximately 15%.

Sanofi’s Jevtana (cabazitaxel) is a leading drug used to treat prostate cancer. The semi-synthetic taxane chemotherapy is FDA approved in combination with prednisone to treat patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

Although sales exceeded $600 million in 2020, the drug has two FDA-mandated black box warnings about neutropenia and severe hypersensitivity associated with polysorbate-80 in the formulation.

DEP cabazitaxel, on the other hand, is a patented, detergent (polysorbate-80) free, nanoparticle version of Jevtana, which is a leading oncology agent used to treat advanced prostate cancer.

Related Article: Cancer Cells Build Nano-Highways to Hijack Mitochondria from Immune Cells

 

Positive Phase 2 Data

Interim results from the Phase 2 trial evaluating DEP cabazitaxel showed that one or more efficacy signals were observed in 100% of prostate cancer patients. About 64% of patients with assessable tumor lesions saw prolonged stable disease and significant reductions in tumor size for up to 36 weeks.

Secondly, 90% of patients with assessable PSA (Prostate Specific Antigen) tumor biomarker levels had a reduction in PSA, with more than half of these patients achieving a reduction in PSA of at least 50%. Around 83% of patients with secondary bone disease exhibited either no progression or an improvement in these lesions. Lastly, 56% of patients who were evaluable for all three measures responded to all three.

Besides, patients also experienced significantly less severe bone marrow toxicity (myelosuppression), significantly lower rates of severe neutropenia, and no instances of neutropenic sepsis, which are all associated with Jevtana.

“The anti-cancer activity, together with less myelosuppression than standard cabazitaxel and a generally well-tolerated safety profile, mean this novel form of dendrimer-enhanced cabazitaxel represents a useful option for prostate cancer patients, including in older patients in whom DEP cabazitaxel has been particularly well-tolerated,” Prof. Joshua added.

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