Brisbane, Australia Tuesday May 4, 2004. Progen Industries...

Brisbane, Australia Tuesday May 4, 2004. Progen Industries Limited (ASX: PGL, NASDAQ:

PGLAF), a progressive Australian anti-cancer drug development company, announced today that
it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for their lead anti-angiogenesis product PI-88 for treatment of malignant melanoma.

Orphan drug designation will provide PI-88 seven years market exclusivity when approved for this disease
indication".
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PGL: 11 Febr: " We have seen positive signs in the PI-88 Phase I single agent trial where over 40% of the melanoma patients showed tumor growth retarded for periods lasting up to 30 months"

Comment.
Sofar, PGL only completed Phase I which was designed to measure safety and other statistics.

Measurement of efficacy is not the aim of Phase I but is the job of Phase II which started in Febr 2004:
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21 Jan: "The completed Phase I study was designed to evaluate the safety, pharmacokinetics and biologic effects of PI-88 self-administered subcutaneously on four consecutive days per week by patients with various advanced cancers.

Experimental dosing ranged from 80 mg to 315 mg with 250 mg selected as the optimal dose according to the study protocol".
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However, I was amazed at the results from Phase I and will be expecting good results in Phase II as they would know pretty well by now the best dosage rates.

I would also expect Europe and other countries to be interested in these results: markets don't stop at the USA's borders.

As mentioned, so far only 9 Orphan Drug Status were given by the FDA since Jan 1 and one these was for an Aussie drug from PGL.

There are other trials progressing.

Gerry
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