Navigation Links
Preliminary PI-88 Phase 2 Prostate Cancer Results to be Presented at the American Society for Clinical Oncology (ASCO) 2008 Genitourinary Cancer Symposium
Date:2/13/2008

BRISBANE, Australia, Feb. 13 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced positive preliminary efficacy results from a phase 2 investigator-initiated trial of PI-88 in combination with the chemotherapeutic agent Taxotere(R) (docetaxel) administered to patients with prostate cancer. Dr. Gavin Marx, Royal North Shore Hospital, Sydney Haematology and Oncology Clinics, the principal investigator conducting the trial, will present the preliminary results of the study today at the American Society for Clinical Oncology (ASCO) 2008 Genitourinary Cancer Symposium in San Francisco.

The investigator-initiated study was a randomized two-arm open-label study design that assessed efficacy and safety of two dose schedules (4 days/week and 7 days/week) of subcutaneous PI-88 in combination with three-weekly Taxotere(R) (75 mg/m2, IV on day 1). The study comprised a lead-in phase 1 safety component to establish the maximum tolerated dose (MTD) of PI-88 at each of the two dosing schedules, followed by a randomized phase 2 component expanding the two dose schedule.

70% of the 55 patients recruited to the trial had a decrease in serum Prostate Specific Antigen (PSA) of greater than 50% for three weeks or longer. These efficacy results compare favourably with the pivotal TAX327 Taxotere(R) registration trial, where 45% of patients had at least a 50% decrease in serum PSA level(1). PSA is a substance produced in the prostate gland, a high level of which may indicate the presence of cancer. In patients with advanced prostate cancer, many clinicians use increasing levels of PSA as an indicator of disease progression.

The trial concluded enrollment early due to a higher-than-expected rate of febrile neutropaenia, a side effect involving a decrease in white blood cells with associated fever. This is a known side effect of Taxotere(R), but was seen in this trial at a substantially greater rate than is generally considered typical for that drug.

Two patients are continuing with PI-88 treatment after successfully completing the combination treatment. Specifically, one patient has remained on the study after 74 weeks while the other remains after 40 weeks.

Dr. James Garner, Progen's Vice President of Clinical and Medical Affairs commented, "We are encouraged by the efficacy trends demonstrated in this patient population. Prostate cancer is an indication with continuing high unmet medical need and there is a clear demand for new therapies here. The febrile neutropaenia rates seen in this study are difficult to interpret, given that this small investigator-led study lacks a control group. We have not seen evidence of febrile neutropaenia in our previous clinical experience combining PI-88 with Taxotere(R), and there is no biological reason to suspect that the combination might result in increased toxicity. We will discuss this unexpected finding with our clinical and scientific advisors to determine the appropriate next steps in terms of development."

Justus Homburg, Progen's Chief Executive Officer continued, "Prostate cancer continues to be an indication we are interested to explore more, therefore, we will continue to analyze the results and do additional work to establish how best to combine PI-88 with existing therapies in this indication. In the interim, our phase 3 study in the adjuvant hepatocellular carcinoma setting is expected to begin recruitment shortly. We do not anticipate any concern regarding febrile neutropaenia in this phase 3 study, as it is a monotherapy study in a patient population with which we already have substantial clinical data."

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.

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 capital needs, general economic conditions, and other risks and uncertainties detailed from time to time in the Company's filings with the Australian Securities 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.

(1) Tannock et al, 2004, N. Engl J Med, 351, 1502-12


'/>"/>
SOURCE Progen Pharmaceuticals Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis
2. Genomic Health Announces Preliminary Results From a Study of Oncotype DX(TM) in Node-Positive Breast Cancer Patients
3. Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) and Boston Scientifics Taxus(R) Stent in Patients at High Risk of Restenosis
4. Sunesis Pharmaceuticals Reports Preliminary SNS-595 Activity in Ovarian Cancer Clinical Trial at AACR-NCI-EORTC International Conference
5. Pharmion and MethylGene Report Preliminary MGCD0103 Clinical Data at the 2007 AACR-NCI-EORTC International Conference
6. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
7. Vion Pharmaceuticals To Present Preliminary Data on its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) at the American Society of Hematology Meeting
8. Pixantrone Versus Doxorubicin in CHOP-R Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Preliminary Results Presented at American Society of Hematology (ASH) Annual Meeting
9. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
10. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
11. A Functional Immune System Can Be Derived From Embryonic Stem Cells, Preliminary Study Finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/5/2017)... , Sept. 5, 2017 Oramed Pharmaceuticals Inc. ... ), a clinical-stage pharmaceutical company focused on the development ... has successfully concluded its meeting with the U.S. Food ... oral insulin formulation. ... the regulatory pathway for submission of ORMD-0801, would be ...
(Date:9/1/2017)... Sept. 1, 2017  Explorers Like Us ( https://explorerslikeus.com/ ) ... aural experiences — and deliver these experiences as part of ... people feel and heal better. ... While nothing beats a walk, jog or ... mind, Life Environments™ is the next best thing when getting ...
(Date:8/31/2017)... NEW YORK , Aug. 31, 2017 ... the industry,s must-read guide to the latest innovations happening ... the first industry publication to focus on providing a ... advancements. Ultimately, the issue covers the most innovative companies, ... year. "Everyone in ...
Breaking Medicine Technology:
(Date:9/21/2017)... ... 21, 2017 , ... With ProSlideshow Portrait from Pixel Film Studios creating a ... select from up to two layers of subject matter along with fully customizable backdrop ... Final Cut Pro X. , With ProSlideshow Portrait each user are given ...
(Date:9/21/2017)... Falls Church, VA (PRWEB) , ... September 21, ... ... **An FDAnews Webinar**, Sept. 26, 2017 — 1:30 p.m. – 3:00 p.m. ET, ... exacting business. It’s easy to get things wrong, run afoul of The Quality ...
(Date:9/21/2017)... Angeles, CA (PRWEB) , ... September 21, 2017 ... ... a lunch and learn with Infinity Behavioral Health Services for professionals in the ... in a Commercial Payer Audit . , Insurance companies and state and ...
(Date:9/21/2017)... IL. (PRWEB) , ... September 21, 2017 , ... ... results released today of a new member survey conducted by the International ... restoration procedures performed from 2014 to 2016 rose 60 percent, with 635,189 procedures ...
(Date:9/21/2017)... ... September 21, 2017 , ... Bill Howe Plumbing’s mission is to create an ... to the community. For over 37 years, they have operated with their mission at ... in San Diego. They were chosen as the Best San Diego plumber in ...
Breaking Medicine News(10 mins):