去年4 月PROGEN公司公布II期试验，用于预防肝癌切除后的复发，结果认为很好，可是最近却宣布终止PI-88的III期临床，而之前的II期临床数据均是由台湾的基亚生物在台湾完成172例，63%的160MG治疗组，50%的对照组（不作治疗）。
Progen Terminates PATHWAY Trial & Confirms Focus on Potential High Value
Molecules and M&A
BRISBANE, Australia, July 22 /PRNewswire-FirstCall/ -- Following a
thorough review that concluded late yesterday, the Board of Progen
Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced that it had
discontinued the PI-88 phase 3 study in liver cancer. Progen confirmed its
strategic direction to develop its existing portfolio of compounds and the
company will actively seek to acquire additional compounds and opportunities
through Merger & Acquisition activity.
The strategic review was triggered by a recent accumulation of a number of
factors that impacted the commercial return for the phase 3 PATHWAY trial.
The trial is unlikely to meet the forecast patient recruitment timetable
and further significant delays were expected due to:
-- slower than expected regulatory processes in China, Korea and Vietnam;
-- slower than expected initiation of clinical sites;
-- slower than expected recruitment of patients into active sites; and
-- the recent launch of a competitive phase 3 trial, assessing Bayer/Onyx
Nexavar(R) in the same indication.
Due to a lack of a global partner willing to meaningfully develop and
commercialise PI-88, the commercial opportunity is much less than previously
expected. Without a significant global partner contributing, Progen will be
less able to expand into additional indications and exploit all potential
PI-88 commercial opportunities.
These aspects would have delayed market entry significantly and seriously
impacted on the commercial return of the phase 3 PATHWAY trial.
The next step is that Progen will seek expressions of interest in PI-88,
at a regional level, initially from amongst those parties that had entered
into Non-Disclosure Agreements and Due Diligence on PI-88.
The PI-88 trial had been facilitated through external agencies, and had
resulted in 23 sites being opened for patient recruitment and 12 patients from
5 recruitment centres having been recruited to date. Existing patients
receiving PI-88 will continue to receive the drug if they wish to do so,
subject to regulatory approval. External costs of the trial in FY2008 are
estimated at $9.8m. The cost of discontinuing this trial is estimated to be
less than $4.0m.
As part of the strategic review, Progen has determined that the current
phase 2b melanoma trial, will be completed but no further development in
melanoma by Progen is anticipated at this stage. This trial is expected be
finalised at an estimated additional cost of $300,000.
In addition, and as part of the strategic review, the Company has also
decided to terminate further development of its phase 1 compound PI-166, based
on a recent commercial assessment of the market and the approval of Nexavar(R)
in this indication.
The Board of Progen has determined that it will increase its focus on the
further development of molecules with high potential value.
Progen will focus its resources on aggressively pursuing its other
compounds in development PG11047 (phase 1), the 500 series (late preclinical)
and the epigenetics platform (early preclinical).
-- Progen has previously announced the phase 1 trial of compound PG11047,
for patients with advanced cancers, which had been the subject of an earlier
phase 1 trial. This extended trial is already showing positive
tolerability/dosing profiles.
-- The 500 series is currently undergoing scale-up manufacture and animal
safety studies.
-- The Board of Progen has confirmed that it will continue to expand its
gene expression modification - epigenetic - compounds platform, added to
Progen's technology platform through the CellGate acquisition.
In parallel, the Company will be actively pursuing merger and acquisition
opportunities to expand its clinical stage pipeline.
Given its strong cash position, Progen will aggressively pursue M&A
activities. As part of this process, Progen will announce in the next weeks
the appointment of corporate advisers to assist with the identification of and
initial discussion with potential acquisitions in Australia and the United
States.
Cash Position as at 30 June 2008: $76.7m, excluding creditors and accruals
of $6.2m (unaudited).
On behalf of the Board of Directors and Management,
Dr Mal Eutick
Chairman
About Progen: Progen Pharmaceuticals is a globally focused biotechnology
company committed to the discovery, development and commercialization of small
molecule pharmaceuticals primarily for the treatment of cancer. Progen has
built a focus and strength in anti-cancer drug discovery and development.
Progen targets the multiple mechanisms of cancer across its three technology
platforms, angiogenesis, epigenetics and cell proliferation. Progen has
operations in Australia and the US.
哈哈哈,当时那台湾老板还来宣传过.吹嘘他们如何如何有实力.
与澳洲一公司合作开发,还有两适应症临床前.
这个项目有点意思，台湾的基亚当年购买了PI-88的4个适应症中的肝癌，作完II期后好象又将所有权卖回去了，不太明白。
Progen Terminates PATHWAY Trial & Confirms Focus on Potential High Value
Molecules and M&A
BRISBANE, Australia, July 22 /PRNewswire-FirstCall/ -- Following a
thorough review that concluded late yesterday, the Board of Progen
Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced that it had
discontinued the PI-88 phase 3 study in liver cancer. Progen confirmed its
strategic direction to develop its existing portfolio of compounds and the
company will actively seek to acquire additional compounds and opportunities
through Merger & Acquisition activity.
The strategic review was triggered by a recent accumulation of a number of
factors that impacted the commercial return for the phase 3 PATHWAY trial.
The trial is unlikely to meet the forecast patient recruitment timetable
and further significant delays were expected due to:
-- slower than expected regulatory processes in China, Korea and Vietnam;
-- slower than expected initiation of clinical sites;
-- slower than expected recruitment of patients into active sites; and
-- the recent launch of a competitive phase 3 trial, assessing Bayer/Onyx
Nexavar(R) in the same indication.
Due to a lack of a global partner willing to meaningfully develop and
commercialise PI-88, the commercial opportunity is much less than previously
expected. Without a significant global partner contributing, Progen will be
less able to expand into additional indications and exploit all potential
PI-88 commercial opportunities.
These aspects would have delayed market entry significantly and seriously
impacted on the commercial return of the phase 3 PATHWAY trial.
The next step is that Progen will seek expressions of interest in PI-88,
at a regional level, initially from amongst those parties that had entered
into Non-Disclosure Agreements and Due Diligence on PI-88.
The PI-88 trial had been facilitated through external agencies, and had
resulted in 23 sites being opened for patient recruitment and 12 patients from
5 recruitment centres having been recruited to date. Existing patients
receiving PI-88 will continue to receive the drug if they wish to do so,
subject to regulatory approval. External costs of the trial in FY2008 are
estimated at $9.8m. The cost of discontinuing this trial is estimated to be
less than $4.0m.
As part of the strategic review, Progen has determined that the current
phase 2b melanoma trial, will be completed but no further development in
melanoma by Progen is anticipated at this stage. This trial is expected be
finalised at an estimated additional cost of $300,000.
In addition, and as part of the strategic review, the Company has also
decided to terminate further development of its phase 1 compound PI-166, based
on a recent commercial assessment of the market and the approval of Nexavar(R)
in this indication.
The Board of Progen has determined that it will increase its focus on the
further development of molecules with high potential value.
Progen will focus its resources on aggressively pursuing its other
compounds in development PG11047 (phase 1), the 500 series (late preclinical)
and the epigenetics platform (early preclinical).
-- Progen has previously announced the phase 1 trial of compound PG11047,
for patients with advanced cancers, which had been the subject of an earlier
phase 1 trial. This extended trial is already showing positive
tolerability/dosing profiles.
-- The 500 series is currently undergoing scale-up manufacture and animal
safety studies.
-- The Board of Progen has confirmed that it will continue to expand its
gene expression modification - epigenetic - compounds platform, added to
Progen's technology platform through the CellGate acquisition.
In parallel, the Company will be actively pursuing merger and acquisition
opportunities to expand its clinical stage pipeline.
Given its strong cash position, Progen will aggressively pursue M&A
activities. As part of this process, Progen will announce in the next weeks
the appointment of corporate advisers to assist with the identification of and
initial discussion with potential acquisitions in Australia and the United
States.
Cash Position as at 30 June 2008: $76.7m, excluding creditors and accruals
of $6.2m (unaudited).
On behalf of the Board of Directors and Management,
Dr Mal Eutick
Chairman
About Progen: Progen Pharmaceuticals is a globally focused biotechnology
company committed to the discovery, development and commercialization of small
molecule pharmaceuticals primarily for the treatment of cancer. Progen has
built a focus and strength in anti-cancer drug discovery and development.
Progen targets the multiple mechanisms of cancer across its three technology
platforms, angiogenesis, epigenetics and cell proliferation. Progen has
operations in Australia and the US.
哈哈哈,当时那台湾老板还来宣传过.吹嘘他们如何如何有实力.
与澳洲一公司合作开发,还有两适应症临床前.
这个项目有点意思，台湾的基亚当年购买了PI-88的4个适应症中的肝癌，作完II期后好象又将所有权卖回去了，不太明白。