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Biotech / Medical : Progen Industries Ltd (PGLAF)

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To: Jorgen Jensen who started this subject4/16/2004 4:15:48 PM
From: Henrik   of 349
 
With a Better Image Than Erbitux, Avastin Will See First-Line Prescribing Increase Dramatically Post FDA Approval, According to New NOP World Health Research
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This could be good news for Progen's PI-88.
Would be nice if a safe shortcut based on solid and "robust clinical dataset" could speed up the approval of PI-88.
Guess we will just have to be patient.
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EAST HANOVER, N.J., April 12 /PRNewswire/ -- Avastin-Genentech's new treatment for colorectal cancer will see its first-line prescribing increase dramatically, following its February 26, 2004 approval by the FDA. NOP World Health's new Event Flash(TM) shows that physicians expect to use Avastin to treat 34% of patients -- a significant jump from the 3% of patients treated with Avastin pre-approval.
Unlike Avastin, Erbitux-Bristol Myers-Squibb's and ImClone's colorectal cancer drug, approved on February 12, 2004, does not have first-line indications. Like Avastin, however, it will see its recent FDA approval substantially boost second or subsequent line prescribing. Both treatments ultimately may be limited by their high costs.
"Both Avastin and Erbitux represent important new treatment options for the 150,000 patients diagnosed with colorectal cancer each year," according to Andrea McDonough, Senior Director of Market Events for NOP World Health.
"Oncologists have more positive perceptions of Avastin -- with more than half saying it will significantly change the way they treat metastatic colorectal cancer and a third saying patients or caregivers have already approached them about trying the new drug."
NOP World Health's new Event Flash on Reactions of Oncologists to FDA Approval of Avastin and Erbitux is based on self-administered surveys with 100 oncologists, each of whom treats at least 10 colorectal cancer patients a month. Surveys were conducted March 5-9, 2004-less than a month after the two drugs received their approvals.

prnewswire.com
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From Chairman's report:
Progen on Track to Meet Milestones
Friday February 27, 6:00 am ET
Further Encouragement for PI-88 from Avastin's Approval

Today also marks an important milestone in Progen's field of research. Genentech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Avastin(TM) (bevacizumab), a Vascular Endothelial Growth Factor (VEGF) inhibitor, to be used in combination with chemotherapy as a treatment for patients with metastatic cancer of the colon or rectum. Stephen Chang, Progen's Chairman commented, "This is outstanding progress for the anti-angiogenesis research area and helps build our confidence in our Phase II compound, PI-88. PI-88 is small-molecule-based and rather than relying on a single mode of action to induce an anticancer response, it inhibits blood vessel growth, or angiogenesis via multiple growth factors including Fibroblast Growth Factors (FGFs) and VEGF, as well as inhibiting other angiogenic agents, including heparanase."

Bolstered by this positive announcement in the angiogenesis research area, the main focus for the company in the calendar year 2004 will be to continue to develop a robust clinical dataset for the lead anti-cancer compound PI-88 and continue the ongoing partnering initiative. Stephen Chang, commented, "In the past six months PI-88 has certainly moved forward its clinical development. Signs of efficacy and a good safety profile have emerged from the clinical program with some patients continuing to receive PI-88 for periods lasting up to 30 months. Two new Phase II trials have commenced just recently for patients with advanced melanoma and non-small cell lung cancer, respectively, and our centers are actively recruiting patients across Australia and the US. We are very excited by the next 12 months and beyond."
Source: Progen Industries
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