emails from dr neil frazer

The following is a thread of emails I received last night from Dr Neil Frazer, the Chief Medical Officer for Prima Biomed.

I asked him a few questions on CVac and the Phase 2b and Phase 3 trials. Also on the lesser known products in the pipeline other than CVac; the Cripto-1 antibody and the HPV vaccine.

All the stock analysis people are doing is off CVac which is obviously the lead product that may not only work in Ovarian cancer but also similar cancers in other parts of the body. However the other two products may be blockbuster in their own right...although in earlier stage development.
However if CVac goes to market, future external funding will not be required for such programs.

Anyways...here are abstracts from the emails.



CVac: With Phase 3 trials being planned in Europe, yet Phase 2b not yet passed...what would happen in the Phase 2b trials failed?

"The phase IIb trial has already provided us the information we needed to validate manufacture in the US. As such it has succeeded to date. It has also shown us that the Cvac? manufactured in the US can be safely delivered to patients. The study will add to our safety database for Cvac? for registration purposes. Since it is not designed or powered to provide a definitive answer on the effectiveness of Cvac, it is very unlikely to fail from an efficacy perspective."

What is the likelihood of CVac going all the way?

"I can only refer you to Dendreon?s success with Provenge ?. As the first approved dendritic cell therapy (for refractory prostate cancer) Provenge? blazed a trail for tumour therapy with a patient?s own primed immune cells. Inherently, Cvac is a very safe product, and with proven efficacy from a registration study, it is indeed possible that it can go all
the way. It is most certainly Prima BioMed?s intention to carry out Cvac ? development with that intent in mind."

Cripto-1 antibody, what is this and what does it do?

"Our joint development program with Bioceros is designed to produce a monoclonal antibody against Cripto-1. Cripto-1 is a target protein involved in helping tumours grow and spread (metastasise). It is only present in foetal tissue and in tumours. If the Cripto-1 protein is blocked by the antibody, we would expect it to control tumour growth and prevent metastasis in multiple tumour types. The program is in early stage development."

HPV vaccine, what is this? How does it work?

"We are in the early stages of collaboration with UNSW and Brisbane University to produce an oral form of the HPV vaccine (Gardasil/ Cervarix). These vaccines are currently administered into a muscle (intramuscularly) and require special storage conditions. Our aim is to create
a version of these vaccines that can be taken by mouth, and have less stringent storage conditions. As such, it may be possible to deliver the vaccine to developing worlds where cervical cancer associated with HPV is a major and developing threat."


"Many thanks for your support of Prima BioMed. We believe we are making good progress to getting Cvac? approval globally. I understand your desire to know more about our programs and I?m sure you appreciate that we share progress with our shareholders when we can."

"Thank you for the link you provided. You are more than welcome to share my response with others, and also the corporate newsletter provided by Martin Rogers. Shortly we will have a NASDAQ listing in the US and I look forward to sharing our progress with investors outside of Australia."


Interesting and informative to say the least...the comment from Neil on CVac phase 2b trials "very unlikely to fail from an efficacy perspective".
Read between the lines on that one!!