AB Science announces issuance of a new European patent for protecting the use of masitinib in pancreatic cancer patients with pain until 2033
AB Science SA (NYSE Euronext – FR0010557264 – AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), today announced that the patent offices of Europe (EP13 773 731.8), Singapore (11201502626P) and South Africa (ZA2015/03054) have each issued a Notice of Allowance for a patent relating to methods of treating pancreatic cancer in a human patient with its lead compound masitinib. To complement patent protection in Europe, counterpart patent applications have also been filed in several major international markets including the United States.
Intellectual Property protection for masitinib is secured in pancreatic cancer until 2033. This newly issued patent further enhances the Company’s key patent family for masitinib and extends protection for masitinib in this indication by 5 additional years.
More specifically, the new patent is directed to the use of masitinib in combination with gemcitabine for treatment of pancreatic cancer in a patient population selected for treatment based upon the predictor factor of disease related pain intensity. This patient population is fully consistent with the current clinical development program of masitinib in pancreatic cancer and ongoing international phase 3 randomized clinical trial (AB12005).
Masitinib has also been granted orphan drug status in pancreatic cancer by both FDA and EMA.
Alain Moussy, CEO and co-founder of AB Science said, “The issuance of this patent is especially timely because the recruitment target of 330 patients in the ongoing confirmatory phase 3 study has just been reached. An interim analysis will be available by the end of this year with a possible resampling option in the overall population with pain or in the subgroup of patients with pain and locally advanced tumour.”
The new patent was based on data generated from the AB07012 phase 3 study of masitinib in treatment of advanced pancreatic adenocarcinoma. Results have previously been published in the peer-reviewed journal Annals of Oncology under the title of, ‘A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer’. This article is freely available at http://annonc.oxfordjournals.org/lookup/doi/10.1093/annonc/mdv133. Key findings from that study are described below:
− It was revealed that the marker of baseline pain intensity, assessed via a visual analog scale (VAS) at baseline, has prognostic value, with patients from this subgroup experiencing aggressive disease progression while receiving Gemzar® (gemcitabine, from Eli Lilly and Company).
− This subgroup represents a critical unmet medical need as evidenced from a shorter median OS of approximately 5.5 months.
− In the pain subgroup, administration of masitinib in combination with Gemzar® produced a statistically significant overall survival advantage of +2.6 months (Hazard Ratio=0.62[0.43;0.89]) when compared with placebo administered in combination with Gemzar®.
− Safety of the combination remained acceptable with no overall detrimental effect on quality of life.
– There is evidence from the scientific literature in support of biological plausibility for the observe masitinib treatment-effect in patients with baseline pain (VAS ≥ 20). The presence of pain in Page 2/3 pancreatic ductal adenocarcinoma is thought to flag an increased mast cell activity within the tumor microenvironment which promotes disease progression.
– Masitinib’s highly selective inhibition of mast cell activation is expected to be of therapeutic benefit by impacting on mast cell related remodeling of the tumor microenvironment.
“A confirmatory phase 3 randomized clinical trial is currently ongoing in this indication with an objective to replicate in a prospective manner the first study’s results which are consistent with the known masitinib mechanism of action and its target, mast cells”, said Professor Olivier Hermine, President of the Scientific Committee of AB Science. “If successful this would support the use of masitinib plus gemcitabine as a new treatment option for this subgroup of pancreatic cancer patients with pain and poor prognosis”.
Further information is available on AB Science’s website: www.ab-science.com.