Norwood Immunology lays its plans

Norwood Immunology (AIM:NIM) CEO Richard Williams is planning a busy year. Along with an Australian trial of GnRH analogue in bone marrow transplant patients, the company is gearing up for preclinical trials Lupron's ability to induce tolerance to donor cells prior to transplantation.

The bone marrow trial is expected to yield results by the end of the calendar year.

The company, along with its big pharma partner TAP Pharmaceuticals, which produces the GnRH analogue Lupron, has recently been given the green light to begin an FDA-approved trial in the US.

This initial trial, which will look at the ability of Lupron to rejuvenate the thymus in patients undergoing autologous (self) bone marrow transplants, is expected to start in the next couple of months at the MD Anderson Cancer Center in Houston, Texas. Norwood is planning to follow it up in the second half of the year with a similar trial in patients undergoing allogeneic (donor) bone marrow transplants.

This second trial will also require a separate IND application to be filed with the FDA, but according to Williams, the two trials are essentially the same, with minor modifications, and the second should pose no problems for either ethics approval or the FDA. Each trial is likely to take 18 months to two years to complete depending on the rate of enrolment.

"We want to get the autologous trial well underway and make sure it is working well, then start the allogeneic trial," Williams says.

"We would hope that we can have data [from the autologous trial] in the market by the end of 2006, beginning of 2007."

Inducing tolerance

Norwood Immunology is planning further trials this year to examine related applications of the Lupron-induced thymic rejuvenation.

At the preclinical stage is an animal study which will examine the use of Lupron for induction of tolerance to the donor cells in the recipient prior to transplantation. If the technique works, says Williams, it may be possible to reduce or eliminate rejection of transplanted organs. The study will provide supporting data for a proposed human transplantation trial.

A second study will monitor patients undergoing prostate cancer treatment with Lupron to examine the reconstitution of the thymus during the course of treatment, generally 4-6 months. While this trial is a monitoring trial and does not require FDA approval, it is expected to provide supportive evidence for a future US trial examining the role of Lupron treatment in enhancing the immune responsiveness of prostate cancer patients to vaccination.

Along similar lines, says Williams, is a proposed melanoma trial, which will look at the ability of Lupron to enhance immune responsiveness to a melanoma vaccine.

"We've identified a partner with a melanoma vaccine under development at a major US cancer hospital and we're looking at our funding options," Williams says.

On the back-burner is a project looking at the combination of Lupron-enhanced thymic reconstitution with gene therapy to combat HIV infection. Williams says that discussions on a potential trial design are ongoing, but a trial is unlikely to commence this year.

As with any small biotech company, funding is always an issue. After last year's AIM float, which raised approximately AUD$15 million, the company has enough cash to take it through 2005, according to Williams, and if 1:1 options granted at the IPO and due to expire in June are exercised, enough cash to last for an additional two years will be generated.

To Norwood's advantage is its relationship with TAP, which is supporting the trials in progress. And the company may have another ace up its sleeve -- as Lupron is already an approved drug and the indications under study are serious, the FDA has been non-committal on the need for extensive Phase III studies.

"Because it is an existing drug, they may take a more benign view," Williams says.

In any case, there is a significant possibility for off-label use, in fact Williams says he knows of several people in Melbourne who are already using the drug off-label on the basis of the early trial results.