email reply from dr neilffrazer

I received an email from Dr Neil Frazer regarding an answer to my question about exactly which ovarian cancer patients were eligible to take part in the phase 3 trials (apart from my great interest as a shareholder, I also have a friend who has had chemo and is currently in remission from the disease).

Yesterday he replied promptly with this information below:



"Just to clarify, the CANVAS study is designed for regulatory reasons to look at a well defined population of patients in a well controlled study, with the purpose of getting Cvac to ovarian cancer patients generally if the study is a success. We would have liked to do a broader study in all ovarian cancer patients, but the design we have used meets the regulators needs and is manageable by our company.

The study will recruit patients who have their ovarian cancer treated by surgical removal, but prior to their first cycle of chemotherapy so that we can collect the cells needed when they are in prime condition, and we can manufacture the vaccine in time to start Cvac immediately following chemotherapy when we believe it will have a solid opportunity to be effective.

It is a very sad fact that I receive many e-mails from ovarian cancer patients who have been through surgery and chemotherapy, or their friends and relatives, and I can't as of today recommend a clinical study where they can have the opportunity to receive the vaccine. In two to four years, we hope that will no longer be the case

In the interim, we have been granted permission in Dubai to supply Cvac to patients with a mucin-1 positive tumour, and around 85% of ovarian cancer patients have tumours that are mucin-1 positive. The Cvac for Dubai is manufactured at our long standing partner manufacturing facility in Melbourne to the highest quality standards.

If you would like additional information on Dubai, please can you contact our general manager there, Dr. Hind AlSaad ([email protected]) and she can explain the process in more detail.

I wish your friend all the best in her fight against this terrible disease. Please let me know if there is anything I can do to help."


Sincerely

Neil Frazer MB ChB
Chief Medical Officer
Prima BioMed Ltd