Navigation Links
Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases

BRISBANE, Australia, Nov. 5 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced additional data from the Phase 2 liver cancer study of PI-88 completed earlier this year. This data was presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases in Boston, USA(1).

As the Phase 2 trial's study period covered 48 weeks from curative surgery, the data analysis described in this presentation was performed to evaluate the treatment's impact when patients with a low risk of experiencing a liver cancer recurrence within twelve months are removed from the analysis population. Patients were removed from the patient population if, based on published prognostic factors, they were considered likely to complete the 12 months of the study without recurrence.

The resultant analysis of those patients who had a high risk of recurrence in the 12-month period shows that PI-88 at least doubled the time to disease recurrence calculated at the 60th percentile (p=0.0107) (control (n=33): 24 weeks versus 160mg PI-88 (n=36): 48 weeks). This compares to a 76% improvement at the 70th percentile (p=0.0867) if all patients are included, as reported earlier this year.

Dr. James Garner, Progen's Vice President of Clinical and Medical Affairs, commented: "We know that around 50% of untreated patients are likely to experience disease recurrence within 12-15 months after they have had curative liver cancer resection. Given our Phase 2 study only assessed the recurrence of disease up to 12 months after surgery; this implies that approximately half of the study population were unable to provide information about the efficacy of the drug. When you remove from the analysis patients unlikely to recur in the study time frame, the treatment effect of PI-88 as measured in the Phase 2 study is more clearly demonstrated."

Dr. Garner further commented: "These data further expand our confidence that our 600-patient Phase 3 study will demonstrate PI-88's effect not only for those patients likely to recur within a relatively short period of time, but also for those whose chance of recurrence is delayed, as the Phase 3 study is designed to treat and follow patients for a longer period of time."

The double-blind placebo controlled Phase 3 study is designed to assess, as its primary endpoint, improvement in disease free survival (DFS), amongst approximately 600 patients in countries across North America, Europe and Asia, following surgery to remove liver cancer tumors. Half of the patients in this study will be administered PI-88 after surgical removal of tumors and the remaining patients will receive a placebo so that a direct statistical comparison between the placebo and PI-88 can be made.

A copy of this poster presentation can be found at

(1) Each year, the American Association for the Study of Liver Diseases

brings together over 6,000 hepatologists and hepatology health

professionals from around the world for its annual meeting to meet

and exchange the latest liver disease research, and discuss treatment


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, 160mg of 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.

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

This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties, including without limitation, risks associated with drug development and manufacture, risks inherent in the extensive regulatory approval process mandated by the United States Food and Drug Administration and the Australian Therapeutic Goods Administration, delays in obtaining the necessary approvals for clinical testing, patient recruitment, delays in the conduct of clinical trials, market acceptance of PI-88, PI-166 and other drugs, future capitals needs, general economic conditions, and other risks and uncertainties detailed from time to time in the Company's filings with the Australian Stock Exchange and the United States Securities and Exchange Commission. Moreover, there can be no assurance that others will not independently develop similar products or processes or design around patents owned or licensed by the Company, or that patents owned or licensed by the Company will provide meaningful protection or competitive advantages.

SOURCE Progen Pharmaceuticals Limited
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
2. Progen Pharmaceuticals Announces Fiscal 2007 Financial Results
3. Progen Announces PI-88 Phase 2 Lung Cancer Results
4. Genaera Corporation Presents Interim Phase 1 Data for Obesity Compound Trodusquemine (MSI-1436) at IBC Conference
5. EntreMed Presents Data for Phase 2 Study of MKC-1 in Metastatic Breast Cancer
6. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
7. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
8. CEL-SCI Presents Data for CEL-1000 as a Vaccine Adjuvant with Recombinant Hepatitis B Virus Protein
9. Ardea Biosciences, Inc. Presents Results of Phase 1 Studies of RDEA806, a Novel NNRTI for HIV, at 47th ICAAC
10. Targanta Presents First Data Demonstrating In Vitro Activity and In Vivo Efficacy of Prodrugs in Osteomyelitis Models
11. Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Osteoporosis
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
Breaking Medicine Technology:
(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)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented ... in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, ...
(Date:6/24/2016)... Vegas, Nevada (PRWEB) , ... June 24, 2016 ... ... Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing ... Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of ...
(Date:6/24/2016)... ... 24, 2016 , ... National recruitment firm Slone Partners is pleased ... and genomics experience, as Vice President of North American Capital Sales at HTG ... leading the sales team in the commercialization of the HTG EdgeSeq system and associated ...
Breaking Medicine News(10 mins):