Navigation Links
Progen's Phase 2 Liver Cancer Trial Exceeds Efficacy Objective

- Phase 3 Patient Enrolment Planned for Second Half of 2007 -

BRISBANE, Australia, April 16, 2007 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited today announced the final stage 1 results of its Phase 2 trial of PI-88 in patients who had previously undergone surgical removal of liver cancer. The 48 week data demonstrated that 160 mg of PI-88 showed an improvement in disease-free rate, the primary endpoint, of 25 percent and prolonged the time to tumour recurrence (disease- free survival) from 27 to 48 weeks, or by 78 percent, building on the 30-week results announced in December 2006.

The first stage of the randomised, two-stage multi-centre Phase 2 trial was designed to determine the appropriate dosage and possible efficacy of PI- 88 in reducing tumour recurrence in liver cancer patients who had previously undergone surgical removal of the cancer. Patients in this stage of the Phase 2 trial were randomly assigned to one of three groups to receive either the standard of care (with no PI-88 treatment), 160 mg of PI-88, or 250 mg of PI- 88, over 36 weeks with a 12 week follow-up period.

    Summary of results

    -- Treatment with 160 mg of PI-88 increased the disease-free rate by

       approximately 25 percent, from 50 percent to 63 percent at 48 weeks

    -- Treatment with 160 mg of PI-88 increased the time to recurrence of

       disease (disease-free survival) by approximately 78 percent, from 27 to

       48 weeks

    -- The final results confirmed the trend identified in the 30-week

       assessment that PI-88 delayed the recurrence of disease and increased

       the likelihood that the patient would be disease free for a longer

       period

    -- The 160 mg dosing level of PI-88 revealed a strong safety and

       tolerability profile and few adverse events directly or possibly

       related to treatment

As the 160mg dose was well tolerated and showed positive results in this study, Progen has decided to pursue the 160 mg dose of PI-88 in the Phase 3 development.

Treatment with the 250 mg dose resulted in thirteen patients discontinuing treatment early partly due to adverse events, possibly related to treatment at this dose level. This impacted the results seen from this treatment arm. The 250 mg dose of PI-88 reduced the disease-free rate by approximately 19 percent as compared to the control group, from 50 percent to 41 percent at 48 weeks, and was inseparable from the control group as to disease-free survival.

"These Phase 2 data clearly support the conclusion that PI-88 has the potential to extend the disease-free survival time of patients with post- resection liver cancer, who have few if any treatment options and a high likelihood of disease recurrence," said Professor Pei-Jer Chen, Director of the Medical Research Department of the National Taiwan University Hospital, and the trial's principal investigator. "We have waited a long time to see progress in this area of research and these data represent an important step in the development of treatments for post-resection liver cancer. PI-88 certainly warrants accelerated clinical investigation to enable us to develop a potential new treatment for liver cancer patients as quickly as possible."

"We are excited with the strong results PI-88 demonstrated in slowing the return of liver cancer," said Justus Homburg, Chief Executive Officer of Progen Pharmaceuticals. "These data give us the confidence to aggressively pursue the development of PI-88 towards registration and commercialisation."

"On the basis of these data and our discussions with FDA, we are no longer contemplating conducting stage 2 of this Phase 2 trial. We are now planning a multinational Phase 3 trial of PI-88 at a dose of 160 mg/day, to begin patient enrolment in the second half of 2007. The Phase 3 trial will be designed with overall survival and disease-free survival endpoints."

About Progen:

Progen Pharmaceuticals (formerly Progen Industries 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.

    Progen Information:

    Justus Homburg

    Progen Pharmaceuticals Limited

    T:  +61-7-3842-3333

    E: 


    Sarah Meibusch

    Progen Pharmaceuticals Limited

    T: +61-7-3842-3318

    E: 


    Media Relations USA:

    Robert D. Stanislaro

    Financial Dynamics

    T: 212-850-5657

    E: 


    Investor Relations USA:

    Evan Smith

    Financial Dynamics

    T: 212-850-5606

    E: 

justus.homburg@progen.com.au sarah.meibusch@progen.com.au robert.stanislaro@fd.com Evan.smith@fd.com

CONTACT: Justus Homburg, +61-7-3842-3333, , orSarah Meibusch, +61-7-3842-3318, , both ofProgen; media relations USA, Robert D. Stanislaro, Financial Dynamics, +1-212-850-5657, ; investor Relations USA, Evan Smith,Financial Dynamics, +1-212-850-5606, justus.homburg@progen.com.au sarah.meibusch@progen.com.au robert.stanislaro@fd.com Evan.smith@fd.com

Ticker Symbol: (NASDAQ-NMS:PGLA)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. 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
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Market - Forecast to 2022" report to their offering. ... method for the patients with kidney failure, it replaces the ... from the patient,s blood and thus the treatment helps to ... chloride in balance. Increasing number of ESRD ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, ... M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... the most handsome men, look naturally attractive. Plastic surgery should be invisible.” He ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
(Date:6/24/2016)... Knoxville, TN (PRWEB) , ... June 24, 2016 ... ... develop population health management skills and infrastructure. Most providers, however, are unsure how ... Population Health Ascend to define a path forward tailored to an ...
Breaking Medicine News(10 mins):