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HCV Vaccine Progress

The Editors at Hepatitis Central
November 11, 2005

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The development of a HCV vaccine is very exciting, even to patients already infected. Although the vaccine will not help them direcly, it shows definite progress in understanding and outsmarting this virus that is known to be difficult to combat due to its rapid mutation. If they are making progress with a vaccine, progress for better treatment must be close behind.

Major Milestone Reached In Hepatitis C Vaccine Program

Select Vaccines (AUSTRALIA)

11 November 2005: Melbourne-based biotechnology company, Select Vaccines Ltd (ASX:SLT), today announced positive results from its first pre-clinical studies of a potential vaccine against hepatitis C.

The results followed nine months of animal studies and represent a major advancement of the hepatitis C vaccine program.

Managing Director of Select Vaccines, Dr Martin Soust, said “We obtained good results in our early studies in the laboratory and in a pilot study and, on the strength of these results, we initiated a dose ranging study in mice.”

“We observed very strong immune responses after just one small dose of less than one microgram of this hepatitis C vaccine,” said Associate Professor David Anderson, Chief Scientific Officer with Select Vaccines.

Hepatitis C specific antibodies were produced by all 46 animals injected with the hepatitis C vaccine, even at the lowest dose studied which was 0.2 micrograms. There was also the induction of significant levels of hepatitis C specific T cells, which suggests the vaccine may promote better overall control of infection.

An immune response of this strength in mice suggests a very strong likelihood that a similarly strong response will be produced in a larger animal species that will be studied in the next round of investigations.

The results exceeded the company’s expectations and suggest that the prospects of developing a human vaccine with a good safety profile are excellent.

“The commercial potential of a vaccine against hepatitis C is substantial. Globally, there are almost 300 million people currently infected with hepatitis C and up to 10 million new infections each year. The market for a vaccine against hepatitis C has been estimated to be worth more than $US500 million. The company is pursuing the development of this vaccine as there is currently no vaccine available” said Dr Soust.

“The next steps in our hepatitis C vaccine program are very clear,” Anderson said. “We plan to undertake further studies in larger animals and to produce purified injectable material under GLP conditions for use in a preclinical toxicology study before moving into a phase I clinical trial.” Professor Anderson explained.

Select Vaccines is developing the hepatitis C vaccine with its proprietary vaccine technology that employs virus-like particles to generate a protective immune response against infection. The platform technology involves producing virus-like particles into which specific vaccine antigens of interest, in this case an envelope protein from hepatitis C virus, have been inserted.

“We have been waiting for the outcome from these initial animal studies before considering a very substantial longer-term commitment to vaccine development. With this proof of the VLP platform in hand we have a very strong indication that we may be able to develop vaccines against other infectious diseases and we will look to accelerate and expand our work accordingly.” said Dr Soust.

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