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:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
(Date:6/24/2016)... 24, 2016  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: ... novel therapeutics for the treatment of grievous blood-based ... closing of its previously announced underwritten public offering ... public offering price of $18.75 per share. All ... by GBT. GBT estimates net proceeds from the ...
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 27, 2016 , ... Quality metrics ... yet in many ways they remain in the eye of the beholder, according to ... a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
Breaking Medicine News(10 mins):