AB Science, a young Paris-based biotech company, has announced the pan-European commercial launch of its veterinary anticancer drug, Masivet
Masivet was approved in November 2008 by the European Medicines Agency (EMEA) for the treatment of dogs with non-resectable grade 2 or 3 mast cell tumours. Masivet's active pharmaceutical ingredient is masitinib, a tyrosine kinase inhibitor. Masitinib, discovered and developed by AB Science, belongs to a therapeutic class of drug known as targeted therapy that is, according to AB Science, revolutionising the treatment of cancer in humans.
Alain Moussy, CEO of AB Science said: "Masivet is the first product ever registered as a cancer treatment in veterinary medicine. AB Science is a dynamic and very entrepreneurial biotech company, and is proud to have introduced a drug that can extend the life of dogs suffering from cancer ahead of the large pharmaceutical companies".
The company says Mastocytoma can be an aggressive cancer with a poor prognosis, and represents up to 20% of all cutaneous canine tumours. Some breeds are particularly susceptible, among them Golden Retrievers, Labradors and Boxers. Cancers have the same prevalence in dogs as in humans (1 dog in 4 will suffer from cancer during its lifetime) but surprisingly, no drugs developed for veterinary medicine with a demonstrated efficacy and safety have ever been approved until the arrival of Masivet.
The company claims two main benefits of the new treatment:
AB Science is a biotech company specialising in developing targeted drugs for high need indications, such as cancers, chronic inflammatory diseases and neurodegenerative disorders. Masitinib is the most advanced drug in the pipeline. Now being marketed in veterinary medicine, masitinib is also under development in humans, with phase 3 clinical studies in pancreatic cancer and in gastrointestinal stromal tumour (GIST).
Alain Moussy said: "This registration in veterinary medicine is good news for the future success of masitinib in humans, for whom we are aggressively developing it in cancers and other indications with high morbidity or pain.
"It is very unusual to develop such an innovative product simultaneously in veterinary and human medicines, and even more so that the product is registered in veterinary medicine first. There is no doubt that experts in human oncology will be watching Masivet's future very closely from now on.. However, people will have to wait a while before benefiting from masitinib because it is unlikely to be available to man before 2012".
For more information, see www.masivet.com and www.ab-science.com
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Here is the abstract: it contains the most recent information I have about Palladia. Does anyone have any relative efficacy studies with a steriod to evaluate?
art malernee dvm
Clin Cancer Res. 2009 Jun 1;15(11):3856-65. Epub 2009 May 26.Click here to read Links
Multi-center, Placebo-controlled, Double-blind, Randomized Study of Oral Toceranib Phosphate (SU11654), a Receptor Tyrosine Kinase Inhibitor, for the Treatment of Dogs with Recurrent (Either Local or Distant) Mast Cell Tumor Following Surgical Excision.
London CA, Malpas PB, Wood-Follis SL, Boucher JF, Rusk AW, Rosenberg MP, Henry CJ, Mitchener KL, Klein MK, Hintermeister JG, Bergman PJ, Couto GC, Mauldin GN, Michels GM.
Authors' Affiliations: School of Veterinary Medicine, University of California, Davis, California.
PURPOSE: The purpose of this study was to determine the objective response rate (ORR) following treatment of canine mast cell tumors (MCT) with toceranib phosphate (Palladia, SU11654), a kinase inhibitor with both antitumor and antiangiogenic activity through inhibition of KIT, vascular endothelial growth factor receptor 2, and PDGFRbeta. Secondary objectives were to determine biological response rate, time to tumor progression, duration of objective response, health-related quality of life, and safety of Palladia. EXPERIMENTAL DESIGN: Dogs were randomized to receive oral Palladia 3.25 mg/kg or placebo every other day for 6 weeks in the blinded phase. Thereafter, eligible dogs received open-label Palladia. RESULTS: The blinded phase ORR in Palladia-treated dogs (n = 86) was 37.2% (7 complete response, 25 partial response) versus 7.9% (5 partial response) in placebo-treated dogs (n = 63; P = 0.0004). Of 58 dogs that received Palladia following placebo-escape, 41.4% (8 complete response, 16 partial response) experienced objective response. The ORR for all 145 dogs receiving Palladia was 42.8% (21 complete response, 41 partial response); among the 62 responders, the median duration of objective response and time to tumor progression was 12.0 weeks and 18.1 weeks, respectively. Palladia-treated responders scored higher on health-related quality of life versus Palladia-treated nonresponders (P = 0.030). There was no significant difference in the number of dogs with grade 3/4 (of 4) adverse events; adverse events were generally manageable with dose modification and/or supportive care. CONCLUSIONS: Palladia has biological activity against canine MCTs and can be administered on a continuous schedule without need for routine planned treatment breaks. This clinical trial further shows that spontaneous tumors in dogs are good models to evaluate therapeutic index of targeted therapeutics in a clinical setting.
Douglas H. Thamm, VMD, DACVIM (Oncology)
Assistant Professor, Oncology
Colorado State University Animal Cancer Center
dthamm@colostate.edu
www.csuanimalcancercenter.org