reckon there's a hint of Nas in the air with all these media release
from the Business Spectator today ...
Prima BioMed to test ovarian 'cancer killer' Published 5:24 PM, 14 Sep 2011
inShare
Source: News Bites
Lead ovarian cancer vaccine developer Prima BioMed has $57 million in cash to tide it over the next two-and-a-half years as it runs its core product, CVac, through USFDA-sanctioned phase III testing and, hopefully, commercialisation.
Ovarian cancer has one of lowest survival rates of all gynaecological cancers and CVac, described by the company as a ?focussed cancer killer?, is designed to address a huge unmet medical need for treatment of the cancer.
The company, which is finalising its 60-patient phase IIb trial, plans to start enrolment for the phase III trial in Q4 this year.
It will be a multinational, multi-centre, randomised, double-blinded, placebo-controlled trial of CVac as a maintenance treatment for epithelial ovarian, primary peritoneal, or fallopian tube cancer in remission.
The trial, which aims to establish that CVac is able to extend the time in remission, extend life expectancy and improve quality of life for patients, will enrol 800 women in remission after completing first-line treatment for ovarian cancer.
Patients will be enrolled at 150 centres in Europe, North America, and Australasia.
CVac is administered post-surgery and post-chemotherapy to delay the relapse and control the metastases of the cancer. The company says ovarian cancer has a very high morbidity rate and there are no maintenance-based therapy products commercially available.
The phase IIb and phase III trials aim to further confirm the ability of CVac to reduce the instance of relapse in ovarian cancer patients and control the metastases of the cancer.
The vaccine, which stimulates the patient's immune system to destroy tumours, consists of an adjuvant, mannan, attached to tumour cell surface protein, mucin-1. The treatment is patient specific and is delivered via autologous dendritic cell therapy. CVac targets cancer cells expressing mucin-1 which are prolific on the surface of ovarian cancer as well as expressed in prostate, pancreatic, kidney, breast, colon and lung cancer cells.
The company is also developing oral medication to expand the application to under developed countries.
Prima?s goal is to commercialise CVac into the global pharmacy oncology market which is estimated at $US3.6 billion ($A3.5 billion).
It expects cash flow from sales in Dubai in 2011 after receiving approval for the marketing of CVac from Dubai Healthcare City.
Chief executive officer Martin Rogers said the company had spent $35-40 million so far on testing the vaccine and expected to spend another $50 million on the phase III trial, taking the total spend to about $100 million - the benchmark for drug development.
Prima BioMed says ovarian cancer is the sixth most commonly diagnosed cancer among women worldwide and causes more deaths per year than any other cancer of the female reproductive system. It is the fifth leading cause of cancer death among women globally. Only three out of 10 women with ovarian cancer live more than five years.
Mr Rogers joined the company three years ago and since that time has seen the register grow from 600 to 15,000 shareholders.
He holds 3.1% and chairman Lucy Turnbull holds 0.5%.
Mr Rogers says the recent capital raising attracted ?household? name institutional investors and he expects this interest to grow with the company being added to the S&P ASX300 index next week.
(20min delay)