Cbio announces drug manufacture success

Cbio announced at the Bio 2002 conference in Toronto that it had successfully manufactured its first drug, called Early Pregnancy Factor (EPF), and was on track to start its first clinical trials next year.

"The success of this initial production phase brings the commercialisation of EPF another step closer," said CBio's chief operating officer, Stephen Goodall.

CBio's managing director Wolf Hanisch said the initial manufacturing runs established that a high yield, high quality product was achievable, and the next step would be to scale the process up, and validate it.

"We know we can make it and now we have to fulfill regulatory requirements before we can start clinical trials," said Hanisch.

Sydney-based Acyte Biotech is developing the manufacturing process for CBio, he said.

EPF is a protein produced early in pregnancy. It appears to be involved in the suppression of autoimmune disease including multiple sclerosis (MS) and rheumatoid arthritis in pregnant women.

The company believes that EPF will be useful in treating autoimmune diseases as well as treatment of burns and ulcers, cancer and assisting skin grafts and transplanted organs.

CBio is initially developing EPF as a potential treatment for MS and other autoimmune diseases. It was discovered almost 30 years ago by Dr Halle Morton and Dr Alice Cavanagh, now both research directors at CBio.