3. data and comments. 3

The previous thread is an important one:

http://www.hotcopper.com.au/post_thread.asp?fid=1&tid=84527&sym=PGL&MSGNO=227592#227592

Shares: 33.9 mill.
Options: 4.2 mill to convert to shares by payment of $2.50 on 31 May 2005; code PGLO. Another 3.42 mill other options. Cash: $16 mill. on Nov 11, 2003.
__________________________________

U.S. FDA grants Orphan Drug Status to PI-88 for Melanoma

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.
The U.S. Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals.

Additional criteria include the ability of the product to address unmet medical need where no approved treatment option exists or, the provision of significant benefit over other available treatments.

Under the Act, upon marketing authorization and during the period of market exclusivity, the FDA does not accept or approve other applications to market the same medicinal product for the same therapeutic
indication.

In addition to potential market exclusivity, orphan drug status provides up to 50% in U.S. tax credits, grant funding for research and development and reduced filing fees, expedited review as well as advice on the conduct of clinical trials.

PI-88, is one of a new class of multi-targeted cancer therapeutics inhibiting both angiogenesis or tumor promoting factors such as Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factors 1 and 2 (FGF-1 and –2), and heparanase, an enzyme implicated in tumor metastasis (tumor spread).

PI-88 is undergoing a Phase II clinical program in metastatic melanoma as a single agent therapy; advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy (Taxotere®); as adjuvant treatment in post-operative primary liver cancer (imminent); and as a single agent therapy in multiple myeloma (completed).

“We believe the strength of PI-88 resides in its ability to inhibit both angiogenesis and metastasis
simultaneously, and we have seen evidence that this potential might be realized across a variety
of cancers,” stated Robert Don PhD, Progen’s VP of Research and Development.

“The FDA’s orphan drug designation further strengthens our program for PI-88 by offering important
accelerated clinical development and commercialization benefits.

We are pleased and gratified by the Agency's support of our efforts to bring PI-88 to patients with this deadly disease.”

Lewis Lee, Progen’s Managing Director, commented “This Orphan Drug designation is an
important step in expediting PI-88’s entry into the market, and it is testimony to our ability to
navigate through the complexities of the US FDA regulatory system.”
END
_________________________

And if you think that a FDA Orphan Drug Status is common, then please think again:

http://www.fda.gov/orphan/designat/designytd.rtf


Only 8 worldwide since 1 Jan; probably 9 now PGL's drug has been granted this designation as well.

Apparently, PGL's is the first Australian one.

Gerry