Richard, a follow up post to your post # 253 "more deep stuff from Progen......"
The attached announcement has a good outline of current and planned trials being or to be undertaken by Progen.
Some price excitement in Progen following the release of this information.
Let's hope the company can follow this up with more encouraging data as the trials program progress.
Today the stock was up 48% on reasonable volume for this tightly held stock.
Past post regarding Progen on this SI thread:
Progen Industries Ltd (PGLAF)
More company information from Progen's company web site: progen.com.au
Holding PGLAF and PGL:ASX
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Progen Company Announcement: Additional Results support Cancer Trials Strategy
Wednesday May 7, 10:52 am ET
MELBOURNE, Australia--(BUSINESS WIRE)--May 7, 2003--
Focal Point
Follow-up data from the ongoing Progen drug development program has affirmed the strategic directions taken in the development of PI-88 and PI-166 by the Australian biotechnology company Progen Industries Limited (ASX:PGL, Nasdaq:PGLAF). Recently reported results from the Phase I/II trial of PI-88 in melanoma demonstrated disease stabilisation in several patients with advanced cancers in whom disease progression is associated with a lack of effective treatment options.
Progen Clinical Trials Summary
Three clinical trials investigating the therapeutic effect of PI-88 on solid tumours including melanoma, lung and liver cancers are underway. To date the company's trial programme of PI-88 has enrolled 80 cancer patients in three countries.
Interim Results from the US Phase I/II Melanoma Trial
Updated interim results from the US Phase I trial involving 32 patients with advanced solid tumours are now being analysed. Progen's Vice President of R&D, Dr. Robert Don, commented, "Disease stabilisation is being observed in nine patients with advanced tumours for up to 22 months. Additionally, two patients have had a measurable reduction in their lung metastases. This is particularly encouraging considering that all patients entering this trial are seriously/terminally ill, previous therapies are no longer effective, and patients have very few standard treatment options left available to them."
Earlier results from this trial were released at the European Organisation for Research and Treatment of Cancer (EORTC) Conference in November 2002. At that time disease stabilisation had been reported for seven, 10 and 17 months respectively in three patients with advanced melanoma. Disease stabilisation has persisted for an additional five months in all three patients and two have a reduction in the size of secondary cancers in their lungs.
"Several additional patients have also been categorised as showing early signs of disease stabilisation after receiving repeated monthly cycles of PI-88 since November 2002," said Dr Don. "This new data has reinforced the company's decision to further develop PI-88 for solid tumours."
Safety data from this trial also adds to the pool of evidence from other ongoing trials that suggest patients are experiencing clinically acceptable drug-related side effects, and that PI-88 is generally well tolerated by patients with advanced cancers.
Other Trials
In patients with advanced cancers, a Phase I combination trial of PI-88 with the chemotherapy agent Taxotere® is also now well underway in the US. This trial is designed to determine the appropriate safe dose of PI-88 when combined with low doses of Taxotere® as a precursor to a subsequent Phase II trial of the combination in patients with advanced non-small cell lung cancer. Six patients have been recruited into this phase 1 study to date and no serious safety concerns with the combination have been reported thus far.
Planning has commenced on a Phase II trial of PI-88 in the post-operative (following surgery) treatment of primary liver cancer (hepatocellular carcinoma or hepatoma) by Progen's alliance partner Medigen.
As of January 2003, Progen's other lead compound, PI-166 is undergoing evaluation in a Phase I clinical trial in patients with inoperable primary liver cancer (hepatoma). The clinical investigations of PI-88 and PI-166 in liver cancer are focused on different stages of the same disease and therefore represent distinct opportunities for both products in this disease area.
The following table provides a snap shot of ongoing and planned trials.
CURRENT TRIALS
----------------------------------------------------------------------
Indication Phase Treatment Status & Key Points
------------------------ ----- --------------- -----------------------
Melanoma I/II Self Dose-finding study -
+ other advanced solid administration Ongoing
tumours of 32 patients treated:
subcutaneous
PI-88.
------------------------ ----- --------------- -----------------------
Advanced Cancer I Combined Combination
Lung cancer and other therapy of dose-finding study -
advanced cancers PI-88 and Ongoing
Taxotere 6 patients treated:
(R)(docetaxel)
------------------------ ----- --------------- -----------------------
Advanced Cancers I Intravenous Dose ranging study -
(IV) Completed.
administration
of PI-88.
------------------------ ----- --------------- -----------------------
Liver Cancer I Single, Dose ranging study -
- Inoperable HCC localised Ongoing
(Hepatoma) administration
of PI-166.
------------------------ ----- --------------- -----------------------
Multiple Myeloma II Subcutaneous Disease marker study -
administration Completed.
of PI-88 Disease Stabilisation
in several patients.
------------------------ ----- --------------- -----------------------
PLANNED TRIALS
----------------------------------------------------------------------
Indication Phase Protocol Key Points
------------------------ ----- --------------- -----------------------
Liver Cancer II Subcutaneous Protocol planning has
(Post surgery) administration commenced in
- Post-resection of PI-88 consultation with
Hepatoma Medigen Biotechnology
Corporation.
------------------------ ----- --------------- -----------------------
Advanced Melanoma II Subcutaneous Protocol finalized.
administration Completion of Phase I
of PI-88. required before
commencement.
------------------------ ----- --------------- -----------------------
Advanced Lung Cancer II Combined Protocol and site
therapy of selection in process.
PI-88 and Commencement subject
Taxotere(R) to satisfactory
(docetaxel) completion of current
Phase I trial
------------------------ ----- --------------- -----------------------
Emerging results from the collective Phase I trials have encouraged the company to focus its efforts toward developing PI-88 in solid tumours in future trials. This strategy is also supported by the fact that collectively, solid tumours represent the largest group of common cancers with many people suffering from these diseases and where there is a very high unmet clinical need.
In reference to this latest update, Progen's Managing Director Lewis Lee said, "Emergence of potentially clinically meaningful results such as these are very encouraging for our investigators who are keen to help patients suffering with advanced disease, and to provide the company with further evidence of the appropriateness of our current and future development strategy."
"The more meaningful the results we can amass in these early stage trials, the more attractive PI-88 becomes as a potential therapeutic for out-licensing," said Mr Lee. "The company strategy remains to seek active out-licensing opportunities with multinational pharmaceutical or large biotechnology companies for PI-88 during or following completion of the current trial program. A licensing partner will continue later stage clinical development (Phase III) and commercialisation of the product."
Mr Lee emphasized however, that "current encouraging indications are from ongoing early stage trials, and the efficacy of PI-88 will need to be confirmed in subsequent larger trials by a licensing partner."
Mode of action
Evidence from previously completed preclinical studies has shown that PI-88 retards the growth of tumours by both inhibiting angiogenesis (new blood vessel growth required by tumours to develop) and metastasis (spread of a primary cancer to other organs/body locations). Angiogenesis and metastasis are common mechanisms used by most cancers to grow and proliferate. PI-88's activity against both of these mechanisms has justified initial investigations into the drug's potential use for a wide range of tumour types in humans.
Keywords - Progen, cancer, PI-88, phase I, phase II, clinical trials, melanoma, solid tumours.
Web links to recent news and other information about Progen:
Progen to manufacture Peplin Compound www.progen.com.au/news/latest_news.cfm?item=289.0
Contract with US based Sequella Inc. www.progen.com.au/news/latest_news.cfm?item=286.0
Half-year report (PDF download available) www.progen.com.au/news/latest_news.cfm?item=288.0
PI-166 Liver Cancer trial Commences www.progen.com.au/news/latest_news.cfm?item=285.0
Progen reports 58% increase in revenue www.progen.com.au/news/latest_news.cfm?item=282.0
PI-88 mode of action www.progen.com.au/researchdevelopment/pi-88.cfm
About Progen: Progen Industries Limited is an Australian biotechnology company committed to the discovery, development and commercialisation of small molecule pharmaceuticals for the treatment of various diseases. Progen's three key areas of expertise are:
Clinical Development via a comprehensive clinical trials programme involving its two lead compounds - PI-88 and PI-166.
Drug discovery projects focusing on the development of potent, selective inhibitors of carbohydrate-protein interactions, which are implicated in many disease processes.
Commercial Services including the manufacture of biopharmaceutical products to world-class standards and distribution of high technology consumable products for large multinational and biotechnology clients.
This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for clinical testing, patient recruitment, delays in the conduct of clinical trials, market acceptance of PI-88, PI-166 and other drugs, future capitals needs, general economic conditions, and other risks and uncertainties detailed from time to time in the Company's filings with the Australian Stock Exchange and the United States Securities and Exchange Commission. Moreover, there can be no assurance that others will not independently develop similar products or processes or design around patents owned or licensed by the Company, or that patents owned or licensed by the Company will provide meaningful protection or competitive advantages.
Contact:
Progen Industries Ltd.
Dr. Robert Don or Lewis Lee, 61 7 3273 9100
Patient Enquiry Line, 0417 436 548
research@progen.com.au
www.progen.com.au
or
Monsoon Communications (Media - Australia)
Richard Allen, 61 3 9620 3333
or
Six Sigma Group (Media - U.S.)
Stephen Anderson, 415/776-6499
Source: Progen Industries Ltd. |
