progen extends pi-88 melanoma clinical program

Progen Extends PI-88 Melanoma Clinical Program

Progen Extends PI-88 Melanoma Clinical Program to First Line Treatment
Brisbane, Australia Wednesday February 2, 2005. Progen Industries Limited (ASX: PGL,
NASDAQ: PGLAF), announced today that the Company is planning a new PI-88 phase II
clinical trial in patients with advanced melanoma in combination with the chemotherapy agent
DTIC (dacarbazine), as first-line treatment. This will involve the treatment of melanoma
patients earlier than in current PI-88 studies; thereby significantly expanding the potential
market for the drug.
An external review panel is currently evaluating patient responses to PI-88 in the current
phase II melanoma study, in which the drug is being investigated as a single-agent in patients
that had established Stage III/IV melanoma that had either not responded to other treatments
or had few treatment options open to them. Recruitment of patients was completed as
planned in 6 months. Although formal assessment of trial data will not be available for several
months, the body of data to date has provided investigators sufficient evidence to support a
combination trial. The new trial is scheduled to start by the end of the next calendar quarter.
Dr Rob Don, Progen’s Vice President for Research and Development commented “We are
encouraged that the melanoma data to date provide meaningful information that allows us to
move PI-88 forward into combination treatment with an established chemotherapy agent as
first-line therapy. This will potentially allow us to treat a greater number of melanoma
patients who are also at an earlier stage of their disease progression and where, based on PI-
88’s mechanism, we would expect to see greater efficacy. PI-88 has been shown to retard the
growth of tumors by inhibiting angiogenesis, or the growth of new blood vessels that feed
tumors, and by inhibiting metastasis, which is the spread of a primary cancer to other areas
and organs in the body. Targeting both processes simultaneously, in combination with
chemotherapy or other agents as early as possible in the disease cycle is believed to be an
effective way to manage cancer.”
In reference to PI-88's recent clinical progress, Progen's Managing Director Lewis Lee added,
“As the current PI-88 phase II program progresses, the quality and amount of data that we
are accumulating are extremely valuable. It is important that we maintain the momentum of
the current clinical program to ensure PI-88’s competitiveness and to aid its
commercialisation. The Company strategy remains to amass a robust PI-88 clinical data
package that reflects proof-of-concept in clinical trials spanning a range of disease indications
providing critical decision-making information required to progress the program towards phase
III clinical development. In parallel, the PI-88 out-licensing initiative continues with
pharmaceutical and biotechnology companies. A suitable licensing partner is being sought to
accelerate and to broaden clinical development and ultimately commercialisation of the
product and Progen expects to continue its involvement with PI-88's development."
Two hundred and thirty three cancer patients and healthy volunteers have now been treated
with PI-88 for periods from one month to up to 42 months. The following table provides a
snap shot of PI-88’s phase II program
Progen’s Clinical Trial Program
Indication Ph Treatment Status & Key Points
Advanced
Melanoma
II
Self-administration of
subcutaneous PI-88 as
a single agent.
Trial initiated January 2004.
Recruitment concluded - 44 patients.
Orphan Drug status granted May 2004; Stage
II (high risk), III and IV melanoma.
External Response Review Panel is assessing
trial data.
Data expected to be finalized by the end of Q2
CY05.
Advanced
Melanoma
II
Combined therapy with
PI-88 and DTIC
(dacarbazine).
Protocol review.
Expected trial initiation by the end of Q2 CY05.
Advanced Lung
Cancer (NSCLC)
II
Combined therapy with
PI-88 and Taxotere®
(docetaxel).
Trial initiated February 2004.
100 patients to be recruited.
Completion of recruitment expected by the
end of Q4 CY05.
Multiple Myeloma II
Self-administration
with subcutaneous PI-
88 as a single agent.
Completed - 19 patients
Disease stabilisation in 41% of evaluable
patients for 8 weeks or longer.
Primary Liver
Cancer
(Post resection or
post surgery)
II
PI-88 adjuvant to
surgery
Self-administration of
subcutaneous PI-88.
Trial initiated July 2004.
340 patients to be recruited.
About PI-88
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, Fibroblast Growth
Factors 1 and 2, and heparanase, an enzyme implicated in metastasis (tumor spread). PI-88
is currently being studied in Phase II clinical trials in the U.S. and Australia under an active
company-sponsored Investigational New Drug application, or IND, with the United States Food
and Drug Administration, or FDA.
About Progen:
Progen Industries Limited is an Australian based globally focused biotechnology company
committed to the discovery, development and commercialisation of small molecule
pharmaceuticals for the treatment of cancer.
Progen’s three key areas of focus are:
• Clinical Development - via a focused clinical trial programme involving its two
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 - manufacturing of biopharmaceutical products to global
standards.
Keywords - Progen, cancer, melanoma, drug discovery, PI-88, PI-166, angiogenesis,
heparanase,
Web links to recent news and other information about Progen:
AGM Managing Director’s Address www.progen.com.au/?page=nepress2004.html
AGM Chairman’s Address www.progen.com.au/?page=nepress2004.html
Phase II Liver Cancer Trial Launched www.progen.com.au/?page=nepress2004.html
PI-88 Receives Orphan Drug Designation www.progen.com.au/?page=nepress2004.html
Third phase II launched – Lung Cancer www.progen.com.au/?page=nepress2004.html
Melanoma phase II Trial Commenced www.progen.com.au/?page=nepress2004.html
PI-88 mode of action www.progen.com.au/?page=repi-88.html
Progen’s drug development pipeline www.progen.com.au/?page=pihome.html
Progen Industries Ltd www.progen.com.au
Contacts:
Progen Information:
Sarah Meibusch
Business Development Manager
Progen Industries Limited
[email protected]
Ph: 61 7 3273 9100
Lewis Lee
Managing Director
Progen Industries Limited
[email protected]
Ph: 61 7 3273 9100
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.