Oasmia Pharmaceutical's drug candidate Paclical® shows promising results in patients with severe cancer

In an initial study with Paclical® in humans carried out by Oasmia
Pharmaceutical AB, Uppsala, Sweden, the maximum tolerable dose of the candidate
was set to 250 mg/m2. In total 34 patients with advanced cancers were treated.
No unexpected side-effects or hypersensitivity reactions were observed. 

In the first Phase I/II study, which was performed in Sweden, both men and
women were treated. Paclical® was administered as three treatment cycles at 3
week's interval.  The first dose was low, 90 mg/m2 and was increased
successively to a maximum dose of 275 mg/m2. The adverse events which occurred
indicated that the dose was too high. As expected, no hypersensitivity
reactions were seen. 

All dosages of Paclical® including 250 mg/m2 were well tolerated by most
patients. The adverse events that were reported were expected at treatment with
paclitaxel which Paclical® contains. A stabilisation of the cancer diseases was
seen in about half of the patients treated with 3 cycles, which is encouraging
considering the severity of the disease in these patients. The dose of
Paclical® in planned studies will be 250 mg/m2 for 6 cycles. As an example, a
common regiment for Taxol® is 175 mg/m2 for 6 cycles. 

Oasmia now conducts a study in patients with ovarian cancer will answer the
question whether 250/mg2 of Paclical® is more efficacious than 175 mg/m2 of
Taxol®. 

Paclitaxel, the active compound in Paclical® has been used against various
kinds of cancers for more than 15 years. The drawback of the drugs containing
paclitaxel on the market is that they contain an excipient consisting of castor
oil and ethanol (Cremophor® EL). Cremophor® El is detrimental and associated
with a number of adverse events, e.g. hypersensitivity reactions that can be
anything from rash to severe shortness of breath. Currently, premedication is
mandatory to reduce adverse events associated with Cremophor® EL. 

One of the many difficulties in treating cancer with cytostatic agents is that
as the cancer cells are destroyed, healthy cells such as white blood cells are
also affected. The challenge is to give a dose high enough to kill the cancer
cells but at the same time avoid reduction of the number of white blood cells
to a level at which the patient is at risk of infections. 

A problem faced with e.g. Taxol® is that the patient is in danger of adverse
events from both paclitaxel and Cremophor® EL. There is a risk that the adverse
events of Cremophor® EL will decide the dose. An excipient which does not cause
adverse events on its own would make it possible to administer higher doses of
paclitaxel and thus obtain a better and more efficacious treatment. 

Oasmia Pharmaceutical AB has developed a novel nanotechnological excipient that
resembles Vitamin A (XR-17). Paclical® consists of paclitaxel dissolved in
XR-17. 

About Paclical® 
With the retinoid based unique platform XR-17, Oasmia has managed to produce a
water soluble formulation of Paclitaxel (Paclical®), that does not require
premedication and abolish Cremophor® EL related side effects. The main
indication is ovarian cancer. Other planned indications are lung cancer (NSLC)
and malignant melanoma. 
 
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