Paris, 03 December 2015, 5.45pm
AB Science announces presentations at
ASH 2015 Annual Meeting and at 8th Annual T-cell Lymphoma Forum
on the development of masitinib in peripheral T-cell lymphoma (PTCL) and
publication in the December 3rd supplemental volume of Blood
On-going phase 3 with masitinib in PTLC will have interim analysis in 2017
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 two abstracts reporting on the development of masitinib for the treatment of peripheral T-cell lymphoma (PTCL) will be presented at two upcoming conferences in the United States.
Professor Olivier Hermine, president of the AB Science Scientific Committee and head of hematology department at the Paris Necker Hospital, will present at the ASH 2015 Annual Meeting and at the 8th Annual T-cell Lymphoma Forum preclinical and clinical evidence that together provide strong medical and biological plausibility for masitinib in the treatment of PTCL. Progress in the on-going phase 3 clinical trial will also be discussed.
- Abstracts and schedule
- ASH 2015 Annual Meeting (December 5-8, in Orlando, US)
One presentation will be delivered at the 2015 American Society of Hematology (ASH) Annual Meeting during a poster session on Lymphoma: Pre-Clinical - Chemotherapy and Biologic Agents.
Development of Masitinib for the Treatment of Peripheral T-Cell Lymphoma
Abstract: #3993
Session: Lymphoma: Pre-Clinical - Chemotherapy and Biologic Agents Poster III
Date, Location: Monday, December 7, (6:00 PM - 8:00 PM); Hall A
This abstract has been selected for publication in the December 3rd supplemental volume of Blood.
- Annual T-cell Lymphoma Forum (January 28-30, 2016, in San Francisco, California)
A second oral presentation will be delivered at the 8th Annual T-cell Lymphoma Forum. Prof. Olivier Hermine will be a speaker during the 'Industrial Perspectives' session of this conference. A link to this meeting's agenda is provided below: http://www.tcellforum.com/pdfs/2016_TCLF_Program_Agenda.pdf
AB Science: Development of masitinib, a novel tyrosine kinase inhibitor and immunotherapeutic, for the treatment of peripheral T-cell lymphoma
Session: Industrial Perspectives (Oral Session 8)
Date: Saturday, January 30, (11:30 AM)
- On-going phase 3 status will have interim analysis in 2017
A phase 3 trial (AB10004) is on-going in patient with relapsed or refractory peripheral T-cell lymphoma.
This is a prospective, multicenter, open-label, three-parallel groups, randomized phase 2/3 trial to evaluate the efficacy and safety of masitinib plus dexamethasone with or without gemcitabine, as compared against the active control of dexamethasone plus gemcitabine, in patients with relapsed or refractory peripheral T-cell lymphoma. The primary endpoint of this study is overall survival.
The study plans to enroll 270 patients. An interim analysis is planned in the protocol and is anticipated in 2017.
- Comparative Oncology Data shows 26% complete responses with masitinib in dogs with T-cell lymphoma
Comparative oncology is the study of naturally developing cancers in animals as models for human disease. Spontaneous cancers in dogs and cats are naturally occurring malignancies that share many features with human cancers. As such, unlike commonly used mice or rat models that are seldom (8%) replicated in human, the efficacy of a drug observed in these naturally occurring animal cancers has far greater probability of being replicated in human cancer.
Masitinib has been the subject of cohort studies that are valuable in their own right and also allow for meta-analysis in larger populations. Meta-analysis of these data (n=23) showed that masitinib treatment of canine T-cell lymphoma resulted in a 26% complete response (6/23 dogs), 35% partial response (8/23 dogs), resulting in an objective response rate 61%.
The development program of masitinib in human PTCL is therefore supported by encouraging clinical data in dogs.
- Scientific rationale is based on the inhibition of PDGF receptor and modulation of the innate immunity
Peripheral T-cell lymphomas not otherwise specified (PTCL/NOS) and other aggressive forms of T-cell lymphomas are fast growing tumors characterized by consistent aberrant expression of platelet-derived growth factor receptor alpha (PDGFRA). A recent publication demonstrated that PDGFRA activity fosters PTCL/NOS proliferation via an autocrine loop. This publication can be accessed through the PubMed link: http://www.ncbi.nlm.nih.gov/pubmed/24480986
Masitinib is an orally administered tyrosine kinase inhibitor that targets a limited number of kinases that play key roles in various cancers. Masitinib has two potential mechanisms of action effective in T-cell Lymphoma. First, masitinib is a potent inhibitor of platelet-derived growth factor receptor, an important target in T-cell lymphoma. Second, pre-clinical data and cumulative clinical experience show that masitinib also acts as an immune therapy through targeting the innate immune system through mast cells and macrophages, the benefit of which is to extend survival by controlling the aggressiveness, transformation, and dissemination of the tumors.
About refractory T-cell lymphoma
Peripheral T-cell lymphomas (PTCL) represent approximately 15% of all non-Hodgkin lymphomas, therefore accounting for around 25,000 new cases per annum in the USA and in the EU. These lymphomas are usually present at diagnosis in stage III or IV, and are often aggressive. There is an important unmet medical need for peripheral T-cell lymphoma in resistance to one line chemotherapy.
Patients with relapsed or refractory T-cell lymphoma have a poor prognosis with a median overall survival of around 6 months and a progression free survival around 3 months. No drug is approved in this population in Europe and patients are treated using conventional chemotherapy as gemcitabine.
About the American Society of Hematology (ASH)
ASH is the world's largest professional society (over 15,000 members from nearly 100 countries) serving both clinicians and scientists around the world who are working to conquer blood diseases. A link to this abstract and meeting's agenda is provided below:
https://ash.confex.com/ash/2015/webprogram/Paper79731.html
About the T-cell Lymphoma Forum
The 8th Annual T-cell Lymphoma Forum is a meeting focusing on the latest information on novel agents and treatment approaches in T-cell lymphoma. A comprehensive program provides a platform for key opinion leaders to gather and exchange ideas and information on the latest research on T-cell lymphoma, including global epidemiology and pathology, immuno-oncology, targeting molecular pathways, and new therapeutic approaches.
About NCI's Comparative Oncology Program
The National Cancer Institute's Center for Cancer Research (CCR) has launched the Comparative Oncology Program (COP) to help researchers better understand the biology of cancer and to improve the assessment of novel treatments for humans by treating pet animals-primarily cats and dogs-with naturally occurring cancer. Further information is available at https://ccrod.cancer.gov/confluence/display/CCRCOPWeb/Home
About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment in cancers, inflammatory diseases, and central nervous system diseases, both in humans and animal health.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine in Europe and in the USA. The company is currently pursuing thirteen phase 3 studies in human medicine in first-line and second-line GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, metastatic colorectal cancer, metastatic prostate cancer, pancreatic cancer, T-cell lymphoma, mastocytosis, severe asthma uncontrolled by oral corticosteroid, Alzheimer's disease, progressive forms of multiple sclerosis, and amyotrophic lateral sclerosis. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science website: http://www.ab-science.com
This document contains prospective information. No guarantee can be given as for the realization of these forecasts, which are subject to those risks described in documents deposited by the Company to the Authority of the financial markets, including trends of the economic conjuncture, the financial markets and the markets on which AB Science is present.
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