NZ Aids drug tested in US

By MARTIN JOHNSTON health reporter

An HIV-Aids drug based on goat plasma and developed in New Zealand will be tested on up to 20 people with the disease in the United States.

The powerful Food and Drug Administration has consented to a trial by a Harvard Medical School doctor of the drug HRG214, which has been developed over the past six years by the Auckland-based Virionyx Corporation and its predecessors.

It was discovered by Dr Frank Gelder, now an executive director of Virionyx.

Company chiefs said yesterday that two patients had started receiving injections of the drug in the four-month Harvard trial.

Neither had suffered bad side-effects.

Chief business officer John Chang said some patients had previously been given the drug in checks on its toxicity, but because of the way they were conducted, it was not possible to draw any conclusions.

A researcher involved in the drug's development, Associate Professor Dale McPhee, deputy director of the MacFarlane Burnet Centre for Medical Research in Melbourne, said the test-tube results from studies of HRG214 were encouraging. "It neutralises not just one isolate [strain] of HIV but a broad spectrum of them."

Traditional HIV drugs slowed the virus' replication; HRG214 killed the virus, he said.

But Dr Chang said that if the drug became a therapy for HIV it was not expected to clear the virus totally from victims' bodies. "This is not a cure."

The drug is made by "immunising" specially selected, disease-free goats with a purified HIV protein. Weeks later, plasma, which then contains antibodies against a certain section of the HIV virus, is extracted from the goats' blood streams.

The liquid is purified and the antibodies are extracted for injection into HIV sufferers.

New Zealand Ministry of Health spokesman Dr Stewart Jessamine said few New Zealand-developed drugs were given FDA approval for United States trials.

But the study the FDA had approved, a so-called phase one trial, was at the level of, "Is this stuff poisonous?"

If it passed that stage, rigorous testing lay ahead before it could go on to the market.

An Auckland Hospital infectious diseases physician, Dr David Holland, said last night, "We have to remain cautious and see what the outcomes of clinical trials are.

"Immuno-therapy as a line of anti-HIV treatment has been thought of in the past but none so far have reached routine clinical use. We have to keep an open mind."

Virionyx, a $100 million company, says that if all goes well for its drug, it could be on the market by 2004.

The company is preparing for a possible listing on the Nasdaq stock exchange in the US but will first wait for positive results from any phase two trials on the effectiveness of the drug.

HIV-Aids afflicts 36 million people and has killed another 21.8 million. .

Dr Jessamine said, "It's not at all uncommon for a drug to go to phase one then get thrown out."