Final advice for Paclical Phase III program
EMEA final advice for start of Oasmia´s Paclical® Phase III program
Oasmia has received a final advice from the EMEA on the clinical Phase III program for Paclical®. The program is scheduled to begin immediately.
The Phase III development program for Paclical® on the indication ovarian cancer has received a final advice from the European Medicines Agency (EMEA). Oasmia is now ready for the next step in the development process. The company has previously re-ceived an Orphan Drug designation on ovarian cancer. The designation protects the product from direct competition for ten years on the indication when registered.
Oasmia has designed the program with assistance from the EMEA to make the future registration process as efficient as possible. The company now plans to initiate the Phase III-program immediately. The Program will be carried out at 35 different sites in Europe.
- This is a major milestone for the company’s clinical program and is a very important step in the development of Paclical® for all indications and not just ovarian cancer, says Oasmia CEO Julian Aleksov in a quick comment.
The positive response will also significantly benefit the development of the company’s other products as confidence in the Oasmia oncology portfolio continues to grow.
The press release is available in PDF-format here.
