Preliminary analysis indicates that Oasmia´s product candidate Paccal® Vet met primary endpoint in Phase III study in dogs with mastocytoma

Uppsala 2010-05-04

PRESS RELEASE                                                                  
               

Oasmia Pharmaceutical AB announced today the preliminary results from a clinical
Phase III study of dogs affected by mastocytoma (mast cell tumours), a type of  
skin cancer. The study measured the effect of Paccal® Vet. Preliminary analysis 
of data supports the primary endpoint that clinical response of dogs treated    
with Paccal Vet was superior to the active control lomustine and that the       
frequency of side effects was comparable between the groups. As expected, Paccal
Vet resulted in less liver dysfunctions than in the lomustine group.            

This is very positive news because of limited treatment options currently       
available for aggressive mastocytoma. A majority of dogs affected by aggressive 
mastocytoma rarely survives more than 6 months. The human registered anti-cancer
drug lomustine has earlier been reported to have efficacy towards canine        
mastocytoma and is currently used in veterinary practice. Oasmia hence          
anticipates that Paccal Vet has the possibility to become a treatment option for
dogs affected by mastocytoma. Currently there is no registered drug on the      
veterinary market with the active substance paclitaxel. Paclitaxel is a         
substance that is currently registered for a wide number of cancer indications  
in human oncology and is today the most prescribed oncology product. The use of 
paclitaxel in dogs has been limited, due to unacceptable side-effects from a fat
soluble formulation. Oasmia's formulation of paclitaxel is based on their novel 
nanoparticular formulation XR-17, which makes paclitaxel water soluble and      
therefore avoids the side effects with conventional paclitaxel. Oasmia intends  
to submit the data to the EMA and FDA for review.                               

- This is very exciting news for us in the veterinary oncology community. It    
would be very interesting if we were able to work with such a unique product as 
Paccal Vet, says Henrik von Euler, associate professor in veterinary oncology at
the Swedish University of Agricultural Sciences, Sweden.                        

- This is an important milestone for Oasmia's Animal Health division. We are    
looking forward to the next step in this process, says Julian Aleksov, CEO at   
Oasmia.                                                                         

About the phase III study                                                       
A multicenter, randomized, observer blind, controlled, Phase III study with     
stratified parallel group design. Patients were stratified according to tumour  
grade (II and III) and stage (IIa and IIIa). 249 patients who suffered from a   
measurable disease of mast cell tumour, grade II or III, and in whom surgery    
could not be performed, were treated in the study. The study measured the       
efficacy and safety of the test drug Paccal Vet compared with the control drug  
lomustine. The drugs were administered over 4 cycles in total with a follow-up  
period of 35 days following the last treatment.                                 
About mastocytoma (skin cancer)                                                 
Mastocytoma is a cancer disease that originates from the mast cells, which are  
part of the body's immune system. Mastocytoma can occur in both sexes, in all   
ages and breeds of dogs. Mastocytoma exists as a systemic disease in which it   
affects the entire body and as a cutaneous disease in which it is located in the
skin. The cutaneous is the most common form in dogs and constitutes             
approximately 20 % of tumours in the skin. The prognosis (meaning the prediction
of the outcome of the disease) of dogs affected by mastocytoma depends upon a   
range of factors, of which two are size and location of the tumour. However, the
most important factor is the grade. Low-grade tumours are more easily cured     
whereas no effective treatment is at present available for dogs with high-grade 
tumours. These tumours are aggressive and can potentially spread to distant     
parts of the body, leading to death for majority of these dogs.                 

About treatment of mastocytoma                                                  
The primarily treatment option at present for dogs affected by mastocytoma is   
surgery. However, successful surgical removal requires a small tumour that is   
located in an area of the body that can be removed without causing extensive    
dysfunction. The border between healthy and tumour tissue is not always clear   
and in order to avoid relapse, a wide margin of 2-3 centimetres surrounding the 
tumour needs to be removed as well. If the tumour is located on the leg, this   
margin might not be achieved without amputation. Local radiation therapy is an  
option if complete surgical removal is not possible. However, radiation therapy 
is not always applicable as the tumour cannot be located close to vital organs, 
the risk for side effects is high and not all tumours respond to radiation      
therapy. Finally, the poor availability of veterinary radiation therapy is      
currently a concern. Another treatment option is chemotherapy (anti-cancer      
drug). Currently, there is no registered drug on the veterinary market that     
targets all types of mastocytomas.                                              

About Paccal® Vet                                                               
Paccal Vet is a novel formulation composed of Oasmia Pharmaceutical's patented  
excipient XR-17 and the anti-cancer substance paclitaxel. XR-17 is a            
nanotechnologically produced model which can be used in order to improve the    
solubility of substances, such as paclitaxel. Paclitaxel is one of the most     
frequently used chemotherapeutic substances in the world. Many chemotherapeutic 
drugs based on paclitaxel are usually dissolved in lipid soluble formulations,  
which are associated with a range of side-effects, both in humans and dogs; in  
humans they can usually be controlled with pre-medication, in dogs the reaction 
is often fatal despite pre-medication. Paccal Vet lacks the lipid soluble       
formulation-related side effects.                                               

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 favorable safety profile and better  
efficacy. The company name was registered in 1999 and is based in Uppsala,      
Sweden.                                                                         



For more information contact: Maria Lundén, Head of Public Relations, Oasmia    
Pharmaceutical AB. E-mail: press@oasmia.com Tel: +46 (0)18 505 440. More        
information is available at www.oasmia.com