Results of PI-88 Phase II Clinical Trial in Melanoma Presented at ASCO
May 16 2005 - 11:14PM
PR Newswire (US)
Results of PI-88 Phase II Clinical Trial in Melanoma Presented at
ASCO BRISBANE, Australia, May 16 /PRNewswire-FirstCall/ -- Progen
Industries Limited (NASDAQ:PGLAF)(ASX:PGL) today announced results
from a Phase II melanoma pilot clinical trial. Key outcomes of the
trial are as follows: -- Treatment with the Company's PI-88 cancer
therapy delivered as a single agent was associated with an
acceptable safety profile and signs of benefit in some patients
with advanced melanoma. -- 44 patients were enrolled in the Phase
II trial, with 37 being evaluable for efficacy. -- One patient had
a partial response and another 10 patients had stable disease (3
with long term clinical benefit) as determined by industry
recognized RECIST criteria. -- The median survival rate of the
patients on this trial was 9.0 months. Survival seen in this study
is comparable to that seen in clinical trials of other melanoma
therapies. It is difficult to compare data from different trials
because of varied patient populations, however a pivotal Phase III
randomized trial resulting in the registration of the drug
temozolomide in Australia, in which 305 patients were treated with
dacarbazine (DTIC) or temozolomide, showed a median survival of 6.4
and 7.7 months respectively.(1) The data seen in this Phase II
study, in which a substantial number of patients had clinical
benefit for prolonged periods, has resulted in the PI-88 melanoma
program progressing to a larger randomised Phase II melanoma trial,
which will investigate PI-88 as first line treatment in combination
with chemotherapy agent DTIC, compared with DTIC alone. This trial
forms part of the Company's Phase II program in which PI-88 is
being investigated in lung cancer (non small cell) in combination
with Taxotere(R) (docetaxel), multiple myeloma, liver cancer
(hepatocellular carcinoma) adjuvant therapy -- post-surgery and
melanoma. Progen Managing Director Lewis Lee commented. "The data
from this PI-88 Phase II trial are encouraging. These have provided
the Company and the investigators sufficient evidence and
justification to enter a combination trial of PI-88 and DTIC and
continue our partnering initiatives for PI-88." PI-88 Clinical
investigator Dr Damien Thomson said " These new data provide
further support for the investigation of PI-88 and provides us
additional confidence to examine the potential benefit of PI-88 as
'first line' treatment of metastatic melanoma in combination with
chemotherapy agent dacarbazine (DTIC), where we hope the drug will
provide additional benefit to patients." Dr Brian Creese, Ph.D.,
Progen's Head of Clinical Development, added "All of these early
but encouraging data that have emerged from this trial are
consistent with what we might expect from PI-88's mechanism. The
aim of the PI-88 clinical development program is to provide a new
treatment option for physicians and patients in several severe
cancer types." The company yesterday announced the Underwriting of
the exercise of the current May 2005 listed Options, effectively
increasing cash reserves by approximately A$8.93 million. A
detailed Clinical Trial Data Summary is posted on our website:
http://www.progen.com.au/ (1) Middleton MR et al. Randomized Phase
III Study of Temozolomide Versus Dacarbazine in the Treatment of
Patients with Advanced Metastatic Melanoma. Journal of Clinical
Oncology. Vol 18(1). Jan 2000. pp.158- 166 Contact: Sarah Meibusch
(Progen) T: +61 7 3273-9100 E: DATASOURCE: Progen Industries
Limited CONTACT: Sarah Meibusch of Progen Industries Limited,
+61-7-3273-9100, Web site: http://www.progen.com.au/
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