Ferrets Stock to Watch: PROGEN PHARMACEUTICALS LTD
09:07, Tuesday, April 17, 2007
COMMERCIAL PROSPECTS INCREASE FOR NEW LIVER CANCER DRUG
Sydney - Tuesday - April 17: (RWE Aust Business News)
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OVERVIEW
********
Shares of biotech stock Progen Pharmaceuticals Ltd (ASX:PGL)
came a cropper yesterday after a dream run of rising market prices.
On Friday the shares stood at $9.11 and went even higher
yesterday before retreating to close at $8.83.
It looks to be a healthy reaction after Progen reported it has
achieved liver cancer Phase 2 trial objectives.
In the market, a stumble due to market forces is often the time
to jump into a stock.
In addition, Progen is a global company listed on the NASDAQ as
PGLA.
Progen yesterday reported progress in its clinical trials.
The results were also released at the European Association for
Liver Research annual Conference in Madrid, giving details of the Progen
trial of its PI88 compound on people with terminal liver disease.
The results have been a great compliment to Professor Parish of
the John Curtin Medical school who developed the idea of using hexase
type compounds during the 1980s and the single mindedness of Progen
Pharmaceuticals to patiently pursue drug development over the last 15
years.
The results also point to the high probability of
commercialisation and are a great boost to the Phase 3 trials which are
soon to begin.
Progen yesterday produced the final stage 1 results of its
Phase 2 trial of PI-88 in patients who had previously undergone surgical
removal of liver cancer.
The 48-week data demonstrated that 160mg of PI-88 showed an
improvement in disease-free rate, the primary endpoint, of 25 per cent
and prolonged the time to tumour recurrence (disease-free survival) from
27 to 48 weeks, or by 78 per cent, building on the 30-week results
announced in December.
The first stage of the randomised, two-stage multi-centre Phase
2 trial was designed to determine the appropriate dosage and possible
efficacy of PI-88 in reducing tumour recurrence in liver cancer patients
who had previously undergone surgical removal of the cancer.
Patients in this stage of the Phase 2 trial were randomly
assigned to one of three groups to receive either the standard of care
(with no PI-88 treatment), 160mg of PI-88, or 250mg of PI-88, over 36
weeks with a 12-week follow-up period.
In summary:
* Treatment with 160mg of PI-88 increased the disease-free rate
by approximately 25 per cent, from 50 per cent to 63 per cent at 48
weeks;
* Treatment with 160mg of PI-88 increased the time to
recurrence of disease (disease-free survival) by approximately 78 per
cent, from 27 to 48 weeks.
The final results confirmed the trend identified in the 30-week
assessment that PI-88 delayed the recurrence of disease and increased
the likelihood that the patient would be disease free for a longer
period.
The 160mg dosing level of PI-88 revealed a strong safety and
tolerability profile and few adverse events directly or possibly related
to treatment as the dose was well tolerated and showed positive results
in this study.
Progen has decided to pursue the 160mg dose of PI-88 in the
Phase 3 development.
Treatment with the 250mg dose resulted in thirteen patients
discontinuing treatment early, partly due to adverse events, possibly
related to treatment at this dose level.
This affected the results seen from this treatment arm.
The 250mg dose of PI-88 reduced the disease-free rate by about
19 per cent as compared to the control group, from 50 per cent to 41
per cent at 48 weeks, and was inseparable from the control group as to
disease-free survival.
"These Phase 2 data clearly support the conclusion that PI-88
has the potential to extend the disease-free survival time of patients
with post-resection liver cancer, who have few if any treatment options
and a high likelihood of disease recurrence," said Professor Pei-Jer
Chen, Director of the Medical Research Department of the National Taiwan
University Hospital, and the trial's principal investigator.
"We have waited a long time to see progress in this area of
research and these data represent an important step in the development
of treatments for post-resection liver cancer.
"PI-88 certainly warrants accelerated clinical investigation to
enable us to develop a potential new treatment for liver cancer patients
as quickly as possible," Dr Chen declared.
Justus Homburg, chief executive officer of Progen
Pharmaceuticals, said the company is excited with the strong results
PI-88 demonstrated in slowing the return of liver cancer.
"These data give us the confidence to aggressively pursue the
development of PI-88 towards registration and commercialisation," he
said.
"On the basis of these data and our discussions with FDA, we are
no longer contemplating conducting stage 2 of this Phase 2 trial. We are
now planning a multinational Phase 3 trial of PI-88 at a dose of
160mg/day, to begin patient enrolment in the second half of 2007."
The Phase 3 trial will be designed with overall survival and
disease-free survival endpoints.
SHARE PRICE MOVEMENTS
*********************
Shares of Progen yesterday hit an all-time high of $9.65 during
the session before closing 28c lower at $8.83 and plumbing a low of
$8.70. High for the year is $9.65 and low $2.48. The company has 46.5
million shares on issue while market cap is $411.2 million
Carla Brookman, an adviser with Bell Potter Securities, has
strongly re-iterated the firm's BUY 2 rating on the basis of the trial
results.
Progen Industries targets discovery, development and
commercialisation of small molecule therapeutics for treatment of cancer
and other diseases.
Its 12-month price target is $16.31.
Based on the company's positive results yesterday, Ms Brookman
believes that it is on track to becoming a very important treatment in
liver cancer.
As consequence of the latest details, the probability of the
drug's success has increased from 60 per cent to 70 per cent.
BACKGROUND
**********
Progen Pharmaceuticals (formerly Progen Industries Ltd) was
listed on the ASX in December 1995, and later on the NASDAQ.
The company is an Australian-based globally focused
biotechnology company committed to the discovery, development and
commercialisation of small molecule therapeutics primarily for the
treatment of cancer.
Progen's three key areas of focus are:
* Clinical Development - via a focused clinical trial program
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; and
* Manufacturing Services - PI-88 manufacturing development and
supply for the clinical program and contract manufacturing services.
The company has an intimate understanding of the role of heparan
sulfate, a complex sugar, in cancer disease processes and have developed
a small-molecule drug development program in this area.
PI-88 is the first product produced from this research and
promising signs of efficacy in humans are emerging from the clinical
program.
A Phase II clinical trial program across multiple cancers has
been running for some time.
Areas of investigation include lung cancer, (NSCLC), primary
liver cancer (hepatocellular carcinoma), multiple myeloma and melanoma
(for which PI-88 has received Orphan Drug status from the US FDA) and
prostate cancer.
This is supplemented by an innovative drug discovery program
that intends to funnel future compounds through the pipeline and into
human trials.
PI-166 has been in-licensed for clinical development for the
treatment of end-stage primary liver cancer and is currently undergoing
Phase Ib clinical development in Australia.
New innovative cancer therapies are currently being screened to
supplement the company's cancer development pipeline.
Progen's manufacturing strength currently lies in the production
of its lead product PI-88 for ongoing clinical trials.
ENDS
Copyright © 2007 RWE Australian Business News. All rights reserved.
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