Oasmia Pharmaceutical aims for worldwide registration with a pivotal study on Paccal® Vet

2009-02-05                                                                     

          
Oasmia Pharmaceutical AB, Uppsala, Sweden is conducting a clinical study on mast
cell tumours in dogs. The study will form the base for a registration submission
of the first cytotoxic drug on the veterinary market ever.                      

The study is approved both by the FDA (US) and the EMEA (EU). The FDA has       
granted Oasmia expedited review which means a much faster approval process. So  
far the study has recruited 30% of the dogs to be included and the results are  
planned to be reported H2 2009.                                                 

With the large market of pet dogs that are diagnosed and managed with cancer    
estimated to be over 1 million per year only in the US (Chand Khanna 2008) the  
recruitment rate will be fast in this Phase III trial as this skin tumour is    
very common. There are over 135 million dogs in the US and EU.                  

The Phase III trial is a comparative randomized controlled blinded multi centre 
study on mast cell tumours in dogs grade II and III. Currently 19 sites in the  
US and 7 sites in the EU are participating, including both major private cancer 
specialist clinics as well as academic sites on both continents. There has been 
a great interest to participate among veterinary cancer specialists, including  
many world leaders in mast cell tumours.                                        

The trial is comparing treatment response to either Paccal® Vet or CCNU         
(Lomustine). The published response to CCNU in mast cell tumours in dogs are 42%
(evaluated in 19 dogs). The progression free survival was 77 days on average.   

This is a big step towards registration of the first chemotherapeutic drug in   
veterinary medicine. The results from prior studies with Paccal® Vet indicate   
that there is a good chance to show superiority against the comparator (CCNU),  
says Dr Henrik von Euler,  study coordinator of two previous studies with       
Paccal® Vet in dogs with cancer, including mast cell tumours.                   

In a recently conducted multi centre open arm trial in dogs with grade II and   
III mast cell tumours with Paccal® Vet. Preliminary results show an overall     
response in 23 dogs treated 3 cycles of 69.5 % with a progression free survival 
of 235 days on average.                                                         


Reference: REF Translation of new cancer treatments from pet dogs to humans,    
Melissa Paoloni and Chand Khanna Nature reviews cancer feb 2008, 147-156.  
     
About Paccal® Vet                                                               
With the retinoid based unique platform XR-17, Oasmia has managed to produce a  
water soluble formulation of Paclitaxel (Paccal® Vet), that does not require    
premedication and abolish Cremophor® EL related side effects. Two clinical      
trials have been performed in client owned dogs with tumors refractory to       
standard treatment. The results are very promising, both regarding tolerability 
and tumor response. Moreover, the studies show that the findings in the dog are 
supporting parallel trials in humans, regarding pharmacokinetics and reported   
side effects. The studies therefore supports the further development towards a  
registration of the first cytotoxic drug on the large cancer market for         
companion animals, as well as serves as a model for human oncology.             

About mastocytoma (Skin cancer)                                                 
Mastocytoma is a malignant form of cancer, originating from the mastocytom cells
of the skin. The disease is graded I - III depending on the seriousness of the  
disease. This form of cancer accounts for approximately 20 % of all malignant   
skin tumours in dogs. Today, the most common form of treatment is surgery,      
although chemotherapy developed for human use is also used. Unfortunately,      
surgery as a treatment of e.g. grade III tumours is mostly ineffective, and     
euthanasia is often the only remaining alternative.                             

About Oasmia                                                                    
Oasmia Pharmaceutical AB develops second and third generation cancer drugs based
on nanotechnology for human and veterinary use. The broad portfolio is focused  
on oncology and contains several promising products in clinical and pre-clinical
phase. Oasmia cooperates with leading universities and other biotech companies  
to discover and optimize substances with a favourable safety profile and better 
efficacy. The company was founded in 1998 and is based in Uppsala, Sweden.      



For more information, please contact: Maria Lundén, Head of Public Relations,   
Oasmia Pharmaceutical AB. E-mail: press@oasmia.com Phone: +46 (0) 18 50 54 40.  
Information is also available at www.ngm.se and www.oasmia.com