Navigation Links
Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
Date:8/19/2007

- Planning for Phase 3 Trial Initiation on Track -

BRISBANE, Australia, Aug. 16 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced it has executed an agreement with Quintiles, the world's largest Contract Research Organisation, to utilise their services for a number of clinical development- related projects. This agreement includes the execution of the Phase 3 clinical trial of anti-cancer drug PI-88 for the treatment of primary liver cancer (hepatocellular carcinoma).

Progen remains on track to initiate recruitment for the Phase 3 clinical trial in the fourth quarter of 2007. Quintiles operates directly in each of the 14 North American, European and Asian countries where Progen will be conducting the Phase 3 PI-88 trial.

"Quintiles has over 18,000 employees world-wide and has managed over 520 separate oncology studies. A number of these employees have been working with us as we prepare to initiate our Phase 3 trial in post-resection liver cancer. We have been consistently impressed with Quintiles's infrastructure in the regions where the trial will be conducted. They have already demonstrated to us that they have the communication and project management systems in place to successfully integrate key clinical operational procedures on the international level that this important trial requires," said Justus Homburg, Progen's CEO.

"Since the middle of last year, we have been working with external advisors, including Quintiles and the U.S. Food and Drug Administration (FDA), to develop our Phase 3 trial. We are aggressively pursuing the launch of this clinical trial on schedule and in parallel continue our discussions with the FDA on the SPA process," concluded Mr. Homburg.

The primary endpoint of the Phase 3 trial is the length of time patients remain disease-free (disease free survival or DFS) following surgery to remove tumour-affected parts of the liver. "Recent feedback from the FDA on our protocol has paved the way for DFS as the primary endpoint for the trial. Other key issues, including the selection of a sample size of 600 patients, have also been resolved. We are now finalising a few remaining aspects of the protocol's Statistical Analysis Plan for further review by the FDA. Critically, whilst we continue our dialogue with the FDA on specific details of the protocol, we are driving hard with Quintiles to launch this trial consistent with the target of starting patient enrolment before the end of this year," added Mr. Homburg.

About Progen: Progen Pharmaceuticals Limited 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.

About Quintiles: Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialisation for the pharmaceutical, biotechnology and healthcare industries. With more than 18,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's web site at http://www.quintiles.com.

Progen Information:

Justus Homburg

Progen Pharmaceuticals Limited

T: +61 7 3842 3333

E: justush@progen-pharma.com

Noreen Dillane

Progen Pharmaceuticals Limited

T: +61 7 3842 3333

E: noreend@progen-pharma.com

Media and Investor Relations Australia:

Rebecca Piercy

Buchan Consulting

T: +61 2 9237 2800 / +61 422 916 422

E: rpiercy@bcg.com.au

Rebecca Wilson

Buchan Consulting

T: +61 417 382 391

E: rwilson@bcg.com.au

Media Relations USA:

Robert D. Stanislaro

FD

T: +1 212 850 5657

E: robert.stanislaro@fd.com

Investor Relations USA:

Evan Smith

FD

T: +1 212 850 5606

E: evan.smith@fd.com


'/>"/>
SOURCE Progen Pharmaceuticals Limited

Copyright©2007 PR Newswire.

Related medicine technology :

1. Progenics and Wyeth Announce Positive Results from Three-Month Clinical-Extension Study of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Advanced Illness
2. Progenics Announces Positive Results in Clinical Trial of Novel HIV Therapy
3. Progens Phase 2 Liver Cancer Trial Exceeds Efficacy Objective
4. Algeta Demonstrates Targeted Cancer-killing Potential of Novel Alpha Particle Linked Antibodies in Leading Medical Journal Blood
5. New Data on Market-Leading Velcade (Bortezomib) for Injection Further Strengthen Role in Previously Treated Multiple Myeloma
6. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
7. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
8. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
9. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
10. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
11. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... March 29, 2017  Experts in the field ... devices like  Soberlink Systems  as a model for ... published in early 2017, concluded that remote blood ... managing patient recovery." The findings of ... Addiction Medicine, detail a range of variables that ...
(Date:3/29/2017)... , March 29, 2017  Glenmark Pharmaceuticals, ... for GSP 301, an investigational fixed-dose combination of ... mcg) administered twice-daily as a nasal spray being ... These results are from a recently completed Phase ... GSP 301 combination therapy versus mometasone, olopatadine or ...
(Date:3/29/2017)... 29, 2017 Research and Markets has announced ... report to their offering. ... The global lifestyle drugs market to grow at a ... report, Global Lifestyle Drugs Market 2017-2021, has been prepared based on ... covers the market landscape and its growth prospects over the coming ...
Breaking Medicine Technology:
(Date:3/29/2017)... ... March 29, 2017 , ... ... for documenting and diagramming network and data center assets and audio-video devices has ... can request new equipment shapes for free and download shapes and stencils from ...
(Date:3/29/2017)... ... 2017 , ... An inventor from Raynham, Mass., knows the ... conjunction with my braces always rubbed against the inside of my cheeks, causing ... problem." The O.B.S. was the result of his brainstorming. , This patent-pending invention ...
(Date:3/29/2017)... ... March 29, 2017 , ... The assembly of synthetic DNA ... many repetitive steps and often scientists require many different versions of DNA. Therefore, ... results in a lower error rate and cost saving for reagents and consumables. ...
(Date:3/29/2017)... ... 29, 2017 , ... Hamlin Dental Group, multi-location dental office in North ... Dental lasers are safe and effective options, and can be used alone or in ... overall quality of care. , Dr. Hamid Reza of Hamlin Dental Group offers other ...
(Date:3/29/2017)... ... March 29, 2017 , ... Physicians’ Education Resource® (PER®), ... medical education conference for clinicians who manage some of the most difficult-to-treat forms ... , The program will be led by co- chairs Dr. John Marshall, chief ...
Breaking Medicine News(10 mins):