Core Viewpoint - AB Science has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering the use of masitinib in treating metastatic castrate-resistant prostate cancer (mCRPC), strengthening its intellectual property position until 2042, in addition to existing coverage in Europe [1][2]. Intellectual Property Position - The new US patent will provide IP protection for masitinib in mCRPC until May 2042, following the confirmation of patentability requirements by the USPTO [2]. - This patent complements the existing European patent (EP4175639) [2]. Clinical Context and Treatment Positioning - Masitinib is positioned as a treatment for mCRPC patients eligible for chemotherapy, specifically in combination with docetaxel, following hormone therapy [5]. - It is one of the few drugs that has shown positive data on progression-free survival (PFS) when combined with docetaxel in this patient population [5]. Study Results - Key results from study AB12003 indicate that masitinib (6.0 mg/kg/day) plus docetaxel significantly improved PFS in mCRPC patients with baseline alkaline phosphatase levels ≤250 IU/L, showing a 21% reduction in the risk of progression compared to control [7]. - The study demonstrated significant improvements in 12-, 18-, and 24-month PFS rates for masitinib plus docetaxel relative to control, with rates increasing by 1.6-fold, 1.9-fold, and 1.9-fold respectively [7]. Unmet Medical Need - Metastatic prostate cancer represents a significant unmet medical need, with a 5-year survival rate of approximately 32% [8]. - The global incidence of prostate cancer is high, with 1.5 million new cases and 397,000 deaths annually, and around 50,000 patients in the EU and 70,000 in the USA are eligible for chemotherapy due to mCRPC [9].
AB Science receives notice of allowance for US patent covering masitinib in the treatment of metastatic castrate resistant prostate cancer