Navigation Links
US FDA Fast Tracks PI-88 for the Treatment of Post Resection Liver Cancer
Date:9/24/2007

BRISBANE, Sept. 24 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) announced today that its investigational anti-cancer drug PI-88 has been awarded Fast Track status by the U.S. Food and Drug Administration (FDA). The fast track designation has been granted to PI- 88 for the prevention of tumor recurrence following curative liver resection in patients with hepatocellular carcinoma (HCC, primary liver cancer).

Under the FDA Modernization Act of 1997, the fast track program is designed to facilitate the development and expedite the regulatory review of new drugs that demonstrate the potential to treat serious or life-threatening diseases where there is an unmet medical need. The Fast Track designation will enable Progen to file a New Drug Application (NDA) on a rolling basis as data becomes available. This permits the FDA to review the different components of the Drug Master File as they are completed in advance of receiving the final submission.

Mr. Justus Homburg, Progen's CEO commented, "This designation will speed the process of bringing this potentially clinically very important drug to patients with liver cancer. The FDA decision to award fast track status to PI- 88 was based on recent Phase 2 clinical data and the high unmet need for treatments for patients with resectable primary liver cancer. The key Phase 2 study showed that PI-88 has the potential to improve the time a patient remains disease free following surgery. As we enter the final stages of clinical development and commence a multinational Phase 3 trial, we look forward to collaborating closely with the FDA to expedite the development and approval of PI-88."

Conservatively, over half a million new cases of HCC are diagnosed worldwide each year, making it the fifth most common cancer and the third major cause of deaths due to cancer worldwide. The most common causes of HCC are related to chronic infection with hepatitis B and C (HBV, HCV). Due to late disease diagnosis, currently only about 25% of patients are eligible for surgery and half of those patients will have their disease recur within 12-15 months. No products have been approved by the FDA to prolong the time a patient remains disease free following surgery.

The fast track designation is fully aligned with Progen's Phase 3 trial design. The double blinded, placebo-controlled Phase 3 trial will be powered for the primary endpoint of disease-free survival determining if PI-88 can prevent early recurrence following curative hepatic surgery. The trial will begin later this year and targets 600 patients with liver cancer post resection, in more than a dozen countries.

About Progen:

Progen Pharmaceuticals Limited is an Australian-based globally focused biotechnology company committed to the discovery, development and commercialization of small molecule therapeutics primarily for the treatment of cancer.

About PI-88:

PI-88 is one of a new class of multi-targeted cytostatic cancer therapeutics. It is a novel anti-cancer compound with a first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor activity is based on inhibition of two biological processes - angiogenesis (the growth of new blood vessels) and metastasis (the spread of cancer to other sites) - critical to the growth and progression of cancer. In a Phase 2 trial in post-resection liver cancer, PI-88 demonstrated a 25% improvement in the primary endpoint of disease-free rate at 48 weeks and 78% improvement in secondary endpoint of disease-free survival. These results, combined with positive feedback from the FDA, provide Progen with confidence in the potential of PI-88 for this indication and we are therefore aggressively pursuing its development towards registration and commercialization.

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

Financial Dynamics

T:212-850-5657

E: robert.stanislaro@fd.com

Investor Relations USA:

Evan Smith

Financial Dynamics

T: 212-850-5606

E: evan.smith@fd.com


'/>"/>
SOURCE Progen Pharmaceuticals Limited
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Stop HIV/AIDS in its Tracks with Education
2. Team Tracks Genetic Origins of Eye Cancer
3. Sex-change Only on Paper? Health Watch Dog Backtracks on Proposal
4. CDC Study Tracks Levels of Heart Diseases Across the U.S.
5. New Imaging Technique Tracks Traffic Patterns of White Blood Cells
6. Allergy Alert on Undeclared Peanuts in Mayfield Turtle Tracks Ice Cream
7. Advances in Treatment of Cataracts
8. Recommendations for Treatment of Blood Pressue
9. Thyroid hormone treatment hastens recovery after cardiac surgery
10. Feeding channel created by malaria parasite - a new target for malaria treatments
11. Now umbilical cord helps in stroke treatment.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, ... treatment. Dr. Cheng has extensive experience with all areas of orthodontics, including robotic ... osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It ...
(Date:6/24/2016)... ... 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ... raise to $12 an hour by 2020 and then adjusting it yearly to increase at ... the minimum wage, assure the wage floor does not erode again, and make future increases ...
(Date:6/24/2016)... Georgia (PRWEB) , ... June 24, 2016 , ... ... awards today at the Clinical Decision Making in Emergency Medicine conference in Ponte ... have authored journal articles published in Emergency Medicine Practice and Pediatric ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... -- Research and Markets has announced ... Applications, Technologies, Forecasts" report to their offering. ... Smart Skin, Structural Health Monitoring, Composite Smart Structures, ... involves electronic and/or electrical components and circuits that ... such as vehicle bodies or conformally placed upon ...
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
Breaking Medicine Technology: