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TDLF CUSIP suspended. FINRA deleted symbol:
https://otce.finra.org/otce/dailyList?viewType=Deletions
anyone still tracking here ... dipped sub-penny looked like nice entry point - now back to .03 ... maybe put in a bid at .009
Yeah looks like a real company.. It just needs to open in Australia.
Thanks. Wished they would stop
halting this. I am going to put in a BID at a much lower price. Let's see how it goes.
It's legit the test and lab are real..But this halts needs to end.
https://www.asx.com.au/asxpdf/20200319/pdf/44g6dw1f5s4010.pdf
https://www.asx.com.au/asxpdf/20200319/pdf/44g6f6c5y0ry3m.pdf
Who sold at .03 today?
I was tempted to buy this today in the AM, but the price ranges all over the place. Cannot get a handle if this is legit.
Are you still watching TDLAF?
Nice day today. Thinking about jumping in on Wednesday in the AM. Hate to jump in after a major run-up, as many will be taking profits. Will watch this. Actually, 2 of the last 3 days here were very good.
Nice day today. Thinking about jumping in.
Hate to jump in after a major run-up, as many will be taking profits. Will watch this.
Nice day today. Thinking about jumping in.
Hate to jump in after a major run-up, as many will be taking profits. Will watch this.
Progen Pharmaceuticals Limited, PGLA, changed to TBG Diagnostics Ltd., TDLAF:
http://otce.finra.org/DLSymbolNameChanges
Just an extremely lame comment about our aussie plunger:
"Volume" is indeed the factor of interest.
The semi good guys are shorting the sht out of her, and nobody
but ye and me is trying to defend this ole pharma.
Obviously, hope for stopping the blood losses is currently bye-bye.
As I write this, we're down to 23 cents (American copper or just copper substitute plastic?).
Well, some of us suckers are indeed still buying, well, at least one I am semi familiar with stupid erratic speculations.
I was he this morning at .235
Of course I fear it's toast in that terrific Black & Decker Toaster-Oven now made en Chine, sold at W-Mart, and imho hard to control if not regulate, tick, tick, and tick.
Ebola is the non-secret word, Groucho, sayeth George Fenimen,
because I dunno the catch phrases 50 years later I'm using a 1950s. The car for you in '52 is Desoto.
Harpo, Chico, Zepo, Sneezey, .... eh, not.
If ya gotta a biotech/pharma with some glean with gl-70 of figuring the ebola hellacious structure which is killing approximately 6 out of 10, then hope it's
a soon predicted bankrupt.
Regretfully, I dunno nuthin, and the market volumes is what
to watch and hope it don't go into 6 digitsif not 7's.
The institutions and other insiders appear to me to be
holding if not buying, but that's merely hopeless
guessing.
So, pray for not saying,"bye," my fellow, hopeless bull-boogers.
The shorts are having an effin blast, and they're calling the bluffs of the ill-informed and of course the dummy boogers.
That's a "buy" signal.
Nice pipeline of drugs
Progen Technology Switches on Cancer Fighting Genes and Inhibits Tumor Growth
BRISBANE, Australia, April 20 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX:PGL)(NASDAQ:PGLA) has released data that shows its epigenetic technology successfully inhibits tumor growth.
The results of the pre-clinical experiments, presented by Progen's collaborators at the 100th Annual American Association for Cancer Research (AACR) Conference, revealed Progen's product was effective in 'switching on' important anti-cancer genes - a significant achievement in epigenetics research and cancer therapeutics.
Progen CEO Justus Homburg said the latest findings reinforced Progen's position at the forefront of anti-cancer drug research.
"Epigenetics represents an exciting new target for cancer therapeutics and is a focus of this AACR meeting. We are very proud to have achieved such promising results in this exciting area of research," he said.
Epigenetics technology represents one of the latest breakthroughs in cancer drug development which focuses on expression (switching on) or silencing (switching off) of certain genes.
Progen and its collaborators have focused their research on an enzyme known as lysine specific demethylase 1(LSD1), which contributes to the silencing of important tumor suppressor genes. They have successfully developed PG11144 that inhibits LSD1 and reactivates (expresses) the silenced genes that are inactivated in cancer.
Progen's Chief Scientific Officer Dr Laurence Marton said the results showed the product successfully inhibited tumor growth in test tubes and living organisms.
"We believe the use of LSD1 inhibitors represents a highly promising and novel approach to cancer prevention and therapy, and may be suitable for multiple indications."
In addition to its epigenetics findings, Progen also presented an update on its cell proliferation technology at the AACR Conference.
Progen's lead cell proliferation product, PG11047, targets hyper-proliferating cells specifically to inhibit tumor growth, and is currently undergoing two phase 1 clinical trials.
The pre-clinical research presented at the Conference showed the product provides a significant additive anti-cancer effect when combined with Cisplatin and Avastin when compared with either drug alone in lung cancer and prostate cancer models respectively.
Progen is currently progressing PG11047 through early clinical development in parallel to additional translational studies to determine the most promising indications.
Mr Homburg said to date, 44 patients had been treated in the monotherapy PG11047 Phase 1 trial, and over 130 patients in combination studies with approved anti-cancer therapies. The dosing regime in the monotherapy trial has been escalated far beyond Progen's original expectations.
"While we expect to find the maximum dose soon, we already have supporting data that the drug will have a large therapeutic window when given as a monotherapy," he said.
Mr Homburg said the latest findings in Progen's epigenetics and cell proliferation technologies represented another important milestone in the development of its anti-cancer portfolio.
"These latest findings prove we have the technology, the expertise and the resources to progress our strong product pipeline," he said.
"We have a fantastic team of collaborators, who have played a significant role in these achievements.
"We are very pleased to have had the opportunity to present these findings on the world stage, among leaders of the international scientific community."
Progen Terminates PATHWAY Trial & Confirms Focus on Potential High Value Molecules and M&A
Tuesday July 22, 8:35 pm ET
BRISBANE, Australia, July 22 /PRNewswire-FirstCall/ -- Following a thorough review that concluded late yesterday, the Board of Progen Pharmaceuticals Limited (ASX: PGL - News; Nasdaq: PGLA - News) today announced that it had discontinued the PI-88 phase 3 study in liver cancer. Progen confirmed its strategic direction to develop its existing portfolio of compounds and the company will actively seek to acquire additional compounds and opportunities through Merger & Acquisition activity.
The strategic review was triggered by a recent accumulation of a number of factors that impacted the commercial return for the phase 3 PATHWAY trial.
The trial is unlikely to meet the forecast patient recruitment timetable and further significant delays were expected due to:
-- slower than expected regulatory processes in China, Korea and Vietnam;
-- slower than expected initiation of clinical sites;
-- slower than expected recruitment of patients into active sites; and
-- the recent launch of a competitive phase 3 trial, assessing Bayer/Onyx Nexavar® in the same indication.
Due to a lack of a global partner willing to meaningfully develop and commercialise PI-88, the commercial opportunity is much less than previously expected. Without a significant global partner contributing, Progen will be less able to expand into additional indications and exploit all potential PI-88 commercial opportunities.
These aspects would have delayed market entry significantly and seriously impacted on the commercial return of the phase 3 PATHWAY trial.
The next step is that Progen will seek expressions of interest in PI-88, at a regional level, initially from amongst those parties that had entered into Non-Disclosure Agreements and Due Diligence on PI-88.
The PI-88 trial had been facilitated through external agencies, and had resulted in 23 sites being opened for patient recruitment and 12 patients from 5 recruitment centres having been recruited to date. Existing patients receiving PI-88 will continue to receive the drug if they wish to do so, subject to regulatory approval. External costs of the trial in FY2008 are estimated at $9.8m. The cost of discontinuing this trial is estimated to be less than $4.0m.
As part of the strategic review, Progen has determined that the current phase 2b melanoma trial, will be completed but no further development in melanoma by Progen is anticipated at this stage. This trial is expected be finalised at an estimated additional cost of $300,000.
In addition, and as part of the strategic review, the Company has also decided to terminate further development of its phase 1 compound PI-166, based on a recent commercial assessment of the market and the approval of Nexavar® in this indication.
The Board of Progen has determined that it will increase its focus on the further development of molecules with high potential value.
Progen will focus its resources on aggressively pursuing its other compounds in development PG11047 (phase 1), the 500 series (late preclinical) and the epigenetics platform (early preclinical).
-- Progen has previously announced the phase 1 trial of compound PG11047, for patients with advanced cancers, which had been the subject of an earlier phase 1 trial. This extended trial is already showing positive tolerability/dosing profiles.
-- The 500 series is currently undergoing scale-up manufacture and animal safety studies.
-- The Board of Progen has confirmed that it will continue to expand its gene expression modification - epigenetic - compounds platform, added to Progen's technology platform through the CellGate acquisition.
In parallel, the Company will be actively pursuing merger and acquisition opportunities to expand its clinical stage pipeline.
Given its strong cash position, Progen will aggressively pursue M&A activities. As part of this process, Progen will announce in the next weeks the appointment of corporate advisers to assist with the identification of and initial discussion with potential acquisitions in Australia and the United States.
Cash Position as at 30 June 2008: $76.7m, excluding creditors and accruals of $6.2m (unaudited).
On behalf of the Board of Directors and Management,
Dr Mal Eutick
Chairman
About Progen: Progen Pharmaceuticals is a globally focused biotechnology company committed to the discovery, development and commercialization of small molecule pharmaceuticals primarily for the treatment of cancer. Progen has built a focus and strength in anti-cancer drug discovery and development. Progen targets the multiple mechanisms of cancer across its three technology platforms, angiogenesis, epigenetics and cell proliferation. Progen has operations in Australia and the US.
Contact Point:
Dr Mal Eutick
Chairman
0416 177 772
Justus Homburg
CEO, Managing Director
T: +61 7 3842 3333
Linton Burns
Company Secretary
T: +61 7 3842 3333
Contact details:
Progen Pharmaceuticals Limited
ABN 82 010 975 612
PO Box 2403 Toowong Qld 4066
T: +61 7 3842 3333
F: +61 7 3720 9624
W: www.progen-pharma.com
PGLA being in Australia and trading on the two exchanges it tends to trade like this pre-market and will more than likely will settle down to its US close.
surf
surf's up......crikey
Morning Surf, I am showing PGLA up 55% to 1.86 in the pre-market on 7500 shares. I can't find any news.
I was wondering if you show same, or if I am just getting a bad quote.
Thanks.
Professional stock market participants recognise Thomson Reuters as a respected research organisation.
Under Pharma matters in Thomson Reuters most recent issue of “THE ONES TO WATCH” they review the five most promising drugs to enter each new phase of clinical development, between January and March 2008 (issued May 19th, 2008).
Progen with its PI-88 is on the top of the list (see pg. 4)
http://www.thomsonpharma.com/media/pdfs/...
“Expert review from Thomson Reuters of the most promising drugs changing clinical phase, receiving approval and launched this quarter, based on the strategic data and insight of Thomson Pharma®, the world’s leading pharmaceutical competitive intelligence solution”.
The five most promising drugs entering Phase III trials
"Turning to the drugs entering phase III this quarter, PI-88 is under development by Progen for the potential treatment of cancers, including solid tumors, multiple myeloma and non-small-cell lung cancer. The drug has a first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor activity is based on inhibition of two biological processes — angiogenesis and metastasis.
Progen reported positive data from phase II trials in February 2008, indicating that PI-88 increases time to tumor recurrence by 76% in patients with post-operative primary hepatocellular carcinoma (HCC). Subjects treated with 160 mg of PI-88 had a 30-week delay in tumor recurrence compared with 17 weeks for those who did not receive the drug. The company also reported high rates of febrile neutropenia.
Global phase III trials for HCC were initiated in March 2008, with the goal of gathering data for regulatory filing. The drug was awarded FDA Fast Track and EC Orphan Drug status for HCC in September 2007".
.......................................
This “most promising drug” status is excellent validation from an independent source of Progen’s PI-88 science.
Note that PI-88 is the only cancer drug listed in the PhaseIII section
Progen holders should be pleased with this recognition.
Progen Resumes Phase 1 Development of Anti-Cancer Agent, PG-11047
Wednesday May 14, 9:16 pm ET
BRISBANE, Australia, May 14 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX:PGL - News; Nasdaq: PGLA - News) today announced that the Company has resumed patient enrolment in the phase 1 dose-escalation study of its recently acquired polyamine analogue, PG-11047 (formerly CGC-11047) for patients with advanced cancer.
Progen has commenced development of PG-11047 - the lead clinical compound in the Company's polyamine program - following its acquisition of Cellgate, Inc earlier this year. The first patient to be recruited into the trial re-initiation has been enrolled at the University of Chicago.
The trial is exploring the potential of PG-11047 as a single anti-cancer agent and is designed to assess the agent's maximum tolerated dose. Under CellGate, the trial had recruited 31 patients and had shown little evidence of toxicity, while using significantly higher doses than most previous studies of polyamine compounds.
Justus Homburg, Progen's CEO, said, "Since the acquisition of CellGate, we have been assessing our portfolio of clinical and pre-clinical compounds in order to determine which to drive forward. Our re-initiation of PG-11047 in phase 1 clinical development is the first step in driving potential value from our expanded portfolio of first-in-class oncology therapies."
Data from the trial will be used in parallel with a separate PG-11047 study assessing the agent in combination with other marketed anti-cancer drugs as the basis for determining potential phase 2 development. Progen expects the study to produce data within the next 12 months.
About Progen: Progen Pharmaceuticals is a globally focused biotechnology company committed to the discovery, development and commercialization of small molecule pharmaceuticals primarily for the treatment of cancer. Progen has operations in Australia and the US.
About PG-11047: PG-11047 is a polyamine analogue which modifies the production of natural polyamines. Polyamines are a class of chemical which are involved in regulation of cell growth. They are overproduced in many cancers, and PG-11047 is believed to restore polyamine reduction to natural levels. Despite being the focus of scientific interest for many years, this mechanism is unique, and if successful, PG-11047 could become a first-in-class oncology product. To date, PG-11047 has been shown to have anti-tumor activity in animal models, combined with a good safety profile.
PG500 Series Presented at the AACR Annual Meeting in San Diego
Monday April 14, 1:46 am ET
BRISBANE, Australia, April 14 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL - News; Nasdaq: PGLA - News) announced today that it had presented new data on its patented PG500 series of compounds at the annual American Association for Cancer Research (AACR) meeting being held in San Diego. The meeting brings together approximately 17,000 participants from around the world to discuss new and significant advances in the knowledge surrounding the causes, diagnosis, treatment and prevention of cancer.
The data presented shows that this series of heparan sulfate mimetic compounds have very strong inhibition of angiogenesis and metastasis and strong anti-tumor activity in some aggressive tumor models. The data firmly supports the continued pre-clinical development of this new series of compounds as anti-cancer agents.
PG545 has been chosen as the lead candidate for additional studies required to support an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). Dr. Anand Gautam, Vice President, Drug Discovery, stated, "PG545 was selected over and above other compounds based on a comprehensive target product profile incorporating aspects such as efficacy, pharmacokinetics, toxicology and ease of manufacture."
Depending upon the outcome of these further studies we expect to submit an IND application with the US-FDA late this calendar year, or early 2009.
About Progen: Progen Pharmaceuticals is a globally focused biotechnology company committed to the discovery, development and commercialization of small molecule pharmaceuticals primarily for the treatment of cancer. Progen has operations in Australia and the US.
About the PG500 series: Progen has an innovative small molecule Drug Discovery team, focused on the design of semi-synthetic oligosaccharide and glycomimetic inhibitors of carbohydrate-protein interactions. The 500 series is the second product line from this research area already showing promising pre-clinical anti-tumor activity.
Progen Restructures Manufacturing and Drug Discovery Divisions
Thursday March 27, 9:06 am ET
BRISBANE, Australia, March 27 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL - News; Nasdaq: PGLA - News) today announced that it will outsource the commercial manufacture of PI-88. The Progen manufacturing facility at the Brisbane suburb of Darra will be retained as a stand-alone business providing process development services and the manufacture of drug development material. Progen expects the transfer of PI-88 manufacture to occur in the next 12 to 18 months.
Progen will maintain the manufacturing facility with existing contracts as a break even operation, and will be assessing its options to either increase facility profitability through additional manufacturing contracts and/or seek a commercial buyer.
"Our manufacturing division has been of great value and has served Progen very well in the past, having made all PI-88 to date, including the supply to be used in the Phase 3 PATHWAY trial as well as having played and continuing to play an important role in supplying contract manufacturing services globally," said Progen's CEO, Justus Homburg.
"However, as far as PI-88 is concerned, the facility was never designed for the manufacture of commercial quantities, and we intend to contract out commercial PI-88 production to an established large-scale commercial bio-pharmaceutical manufacturer."
Further, following several years of in-house active drug development, the chemistry on newly identified lead compound PG545 has essentially been completed. PG545 has been selected for investigational new drug (IND) enabling studies, which are being outsourced.
The restructure involves 8 redundancies in the manufacturing division and 4 in drug discovery and aims to conserve current cash reserves for driving present and future Progen lead compounds towards commercialization.
In summary, following the decisions taken, Progen will:
-- Contract out the commercial supply of PI-88 to an established
bio-pharmaceutical manufacturing facility that has a long-standing
history of producing commercial bio-pharmaceuticals with FDA approvals;
-- Downsize its manufacturing facility from 17 to 9 FTE staff;
-- Downsize its drug discovery team from 12 to 8 FTE staff; and
-- Retain key staff:
- For continuing development of Progen's discovery heparanase
inhibitor program;
- For biological assessment of the expanded Progen portfolio of
preclinical compounds; and
- To manage the transfer of manufacturing know-how and the submission
of, amongst others, the Chemistry, Manufacturing and Controls (CMC)
parts of the New Drug Application (NDA).
Preliminary PI-88 Phase 2 Prostate Cancer Results to be Presented at the American Society for Clinical Oncology (ASCO) 2008 Genitourinary Cancer Symposium
Wednesday February 13, 9:28 am ET
BRISBANE, Australia, Feb. 13 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL - News; Nasdaq: PGLA - News) today announced positive preliminary efficacy results from a phase 2 investigator-initiated trial of PI-88 in combination with the chemotherapeutic agent Taxotere® (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® (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® 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®, 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®, 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."
Progen Expands Drug Development Pipeline Through Acquisition of CellGate
Monday February 4, 8:30 am ET
- Transaction to Broaden Progen's Oncology Product Candidate Portfolio
- Conference Call Scheduled for 5 February 2008, 09:00 Australian EST, 4 February 2008, 17:00 US EST
BRISBANE, Australia, Feb. 4 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL - News; Nasdaq: PGLA - News) announced today that the Company has executed a Definitive Agreement to acquire privately-held U.S. oncology company CellGate, Inc. The CellGate acquisition will expand Progen's product candidate portfolio through the addition of multiple pre-clinical and clinical oncology compounds focused on polyamine and epigenetic targets. CellGate's assets include a lead product candidate in Phase 1 and multiple pre-clinical compounds.
As a result of this acquisition, Progen will:
-- expand its cancer-focused clinical development portfolio by adding a
novel Phase 1 compound
-- leverage its core capabilities in late pre-clinical and early clinical
development of oncology compounds
-- add more than ten compounds in pre-clinical development
-- gain platform technologies in the areas of epigenetics and polyamines
that will form the foundation for new compound development.
Epigenetics, or the silencing of cancer related gene expression, is becoming a well-defined target in oncology and Progen is excited to be entering this new frontier of cancer treatment.
Progen's CEO, Justus Homburg, said, "We are especially pleased that we have acquired such a large number of product candidates in very exciting and novel technology platforms. This transaction represents a minimally dilutive up-front investment by Progen and allows us to continue expanding our product pipeline, with limited risk, while focusing on building long-term value for our shareholders. We are confident that we have the financial resources to drive this new portfolio of assets to the next decision points in the coming 18 months while continuing our development programs for PI-88, PG500 and heparanase inhibitors."
"The merger of the two companies represents an important opportunity for CellGate and its shareholders," said Chris Mirabelli of HealthCare Ventures. "The transaction will maximize the value of CellGate's assets by combining leading pre-clinical and clinical programs in oncology within a strong, diverse company with the resources to support ongoing discovery and development efforts."
Progen's near-term goals are to drive PI-88 towards commercialization, move the PG500 series into the clinic, create new pre-clinical heparanase inhibitor products from Progen's discovery platform, and continue growing the Company through acquisitions and in-licensing. Progen's overriding objective is to expand its PI-88 platform and transform into a leader in the development of novel oncology products. This acquisition is a decisive step toward accomplishing that objective.
In addition to pipeline assets, Progen will also be gaining the extensive expertise of CellGate's Chief Scientific Officer, Dr. Laurence Marton. Dr. Marton is a leading polyamine expert with substantial experience in cancer drug development, and will be a strong addition to the Progen management team. Prior to Joining CellGate, Dr. Marton served as Dean of the University of Wisconsin-Madison Medical School; and before that was Chair of the Department of Laboratory Medicine at the University of California, San Francisco. Dr Marton has extensive experience in the field of cell growth. His research has resulted in more than 165 original publications, 60 scientific reviews and chapters, four books, and numerous patents.
About CellGate
CellGate, located in Redwood City, California, is a biotechnology company with oncology assets based on epigenetic and polyamine inhibition. CellGate brings to Progen an early generation polyamine analog, CGC11047, in Phase 1 clinical development. Progen intends to take CGC11047 through a rigorous pre- and clinical assessment in the coming 18 months before determining a future mid-stage clinical development program for this product candidate. Complementing this first generation clinical candidate is a series of next- generation pre-clinical compounds that have shown strong anti-tumor activity in animal cancer models. These compounds represent potential new drug candidates for Progen that target both the polyamine as well as epigenetic pathways. In addition, CellGate has active research collaborations with Johns Hopkins and Wayne State Universities with the goal of generating new compounds with strong activity against the epigenetic targets LSD-1 and HDAC.
http://biz.yahoo.com/prnews/080204/nym070.html?.v=101
Progen Pharmaceuticals Limited - Financial Update
BRISBANE, Australia, Jan. 31, 2008--Progen Pharmaceuticals (ASX: PGL, NASDAQ: PGLA) today advises that the first half loss is expected to be in the range of $AUD14.0 million to $AUD14.5 million. This is an increase of approximately 30% over the previous corresponding reporting period loss of $AUD10.95 million.
http://www.pharmalive.com/News/index.cfm?articleid=510668&categoryid=36%2C61
http://news.smh.com.au/progen-expects-to-post-increased-loss/20080201-1pj8.html
PROGEN PROVIDES UPDATE ON PHASE 3 CLINICAL PROGRAM FOR PI-88 IN LIVER CANCER
Brisbane, Australia. 21 December 2007.
Progen Pharmaceuticals Limited (ASX: PGL; NASDAQ: PGLA) today provided an update on clinical trial enrollment associated with its phase 3 hepatocellular carcinoma (HCC, primary liver cancer) study. The study has begun initiating sites and is now open for patient recruitment, though a thorough examination of available surgical cases has not yet found any eligible patients who are able to be enrolled by 31 December 2007.
Consequently, the Company now anticipates that first patient in will be achieved early in the new year. Given the delay is solely due to the first site being initiated so close to year-end, the Company does not expect that this will have any impact on overall study timelines or registration strategy.
At this point in time, Progen has received regulatory approval to conduct the phase 3 trial in several countries. The Company has also obtained ethics approval at five trial centres, one of which has been initiated and is open to recruitment.
Further regulatory and ethics approvals will follow early in 2008, and sites will be initiated as soon as they are able to begin enrolment.
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 April 2007, data from a randomised phase II trial in the post resection liver cancer setting was presented at the European Association for the Study of the Liver (EASL) meeting in Barcelona, Spain. PI-88, in this disease setting, has been granted Orphan Drug designation by the European Medicines Evaluation Agency (EMEA) and Fast Track designation by the United States Food and Drug Administration (FDA). These results 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 the phase 3 study: The phase 3 study investigating PI-88 as a post-resection treatment for hepatocellular carcinoma (HCC, primary liver cancer) following curative resection is a double-blinded, placebo-controlled study, that has been designed to establish the efficacy and safety of PI-88 in the post-resection HCC setting. The trial will recruit approximately 600 patients at about 60 hospitals in 14 countries. Disease-free survival will be the primary endpoint. Upon completion of this trial, the results are expected to form the basis of global regulatory filings for PI-88.
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.
Progen's PI-88 Phase3 now recruiting patients
http://clinicaltrials.gov/ct2/show/NCT00568308
Stock code:
PGLA & PGLAW
Bought some PGLA yesterday, this looks to be trading retail tax loss sellers on low volume. I hope when it ends the thin volume will help us to the upside.
Phase III Study of PI-88 in Post-Resection Hepatocellular Carcinoma (PATHWAY)
Full study details from FDA
http://clinicaltrials.gov/ct2/show/NCT00568308?term=liver+pi-88&rank=1
Reminder about this afternoon's presentation @ 3pm EST.
Link to Progen Pharmaceuticals Limited (NASDAQ: PGLA) webcast:
http://www.wsw.com/webcast/rrshq12/pgl.au
According to the program the presentation is now scheduled to start at 3:00 PM EST
(The conference schedule is tentative and subject to change without notice. Please check this page daily for updates.)
Link to conference website:
http://www.rodmanandrenshaw.com/conferences?id=6
-------------------------------------------
Progen Pharmaceuticals to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
Brisbane, Australia. 29 October 2007: Progen Pharmaceuticals Limited (ASX: PGL; NASDAQ:PGLA) today announced that Justus Homburg, Chief Executive Officer, will present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference at the New York Plaza Hotel, on Wednesday, 7 November, 2007 at 3:20 PM EDT (Thursday, 8 November, 2007 at 6:20 AMBrisbane EST).
The audio presentation will be webcast live, and can be accessed on the Company's website at www.progen-pharma.com
A replay of the webcast will be available for 90 days thereafter.
Now in its ninth year, the Acumen BioFin Rodman & Renshaw Annual Healthcare Conference is an international informational service and networking opportunity for healthcare companies and investors. The event is sponsored by leading investment banking firm Rodman & Renshaw, a full service investment bank dedicated to providing investment banking services to companies that have significant recurring capital needs due to their growth and development strategies.
With more than 350 biotechnology companies presenting, the conference provides the opportunity to engage with international investors, venture capitalists, company executives, scientists and industry leaders, as well as experts from the global medical, scientific and investment communities.
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.
With permission from the author posted to Ihub in order to keep the forum informed.
QUOTE
Not to keep going back to the HCC data, but I don't want to understate the validity and utility of what Progen did with the data in the AASLD presentation.
This is a reformulation of my thinking and may help those concerned with the "data-mining" aspect of post-hoc analysis.
In many cases, a post-hoc sub-group analysis involves looking at sick patients and finding "reasons" why some got better and some were not helped by the therapy. Often this involves looking at numerous markers and perhaps trying to determine which patients should recieve the drug in the future. This is sometimes a desperate attempt to show that the drug DOES work in some patients, by excluding sick patients that did not benefit. What was done with the HCC data is quite different. The subgroup identified as high-risk is comprised of patients that are likely still "cancerous". The excluded patients (low-risk) were likely to be disease free for quite some time, and hence not "sick". This is hardly the same situation as the "desperate" case above.
What needs to be understood is that the high-risk group is defined largely by the aggressiveness of the cancer. Aggressiveness comes from genetic instability and variation (the source of the "histopathology" referred to in the poster) and signs of recruitment of blood vessels (and possibly immune suppression, although this is harder to "see"). This aggressive cancer is more likely to leave residual disease (and more aggressive disease) after resection, therefore this patient is more likely to be "sick". If a patient is low risk (having a less aggressive cancer), the tumor was more likely completely removed, and that patient may even be considered "cured". There is good reason to remove the low risk patients from the data.
Rather than being a post-hoc analysis that excludes sick non-responding patients (typical data-mining), this is more akin to removing healthy volunteers from data in order to produce a more appropriate data-set.
They did the right thing for the right reasons. I am even more impressed now than after my first look at the presentation.
End of quote
Posted in connection with this PGLA announcement.
http://www.progen-pharma.com/prs/AASLD%202007a.pdf
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. 5 November 2007: 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, USA1.
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, 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 www.progen-pharma.com.
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 outcomes.
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
Progen Pharmaceuticals to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
Brisbane, Australia. 29 October 2007: Progen Pharmaceuticals Limited (ASX: PGL; NASDAQ:PGLA) today announced that Justus Homburg, Chief Executive Officer, will present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference at the New York Plaza Hotel, on Wednesday, 7 November, 2007 at 3:20 PM EDT (Thursday, 8 November, 2007 at 6:20 AM Brisbane EST).
The audio presentation will be webcast live, and can be accessed on the Company’s website at www.progen-pharma.com. A replay of the webcast will be available for 90 days thereafter.
Now in its ninth year, the Acumen BioFin Rodman & Renshaw Annual Healthcare Conference is an international informational service and networking opportunity for healthcare companies and investors. The event is sponsored by leading investment banking firm Rodman & Renshaw, a full service investment bank dedicated to providing investment banking services to companies that have significant recurring capital needs due to their growth and development strategies.
With more than 350 biotechnology companies presenting, the conference provides the opportunity to engage with international investors, venture capitalists, company executives, scientists and industry leaders, as well as experts from the global medical, scientific and investment communities.
http://www.progen-pharma.com/prs/Rodman%20and%20Renshaw%20Conference%20final.pdf
Progen to Present Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
Brisbane, Australia. 2 November 2007: Progen Pharmaceuticals Limited (ASX:PGL; NASDAQ:PGLA) today announced that Dr James Garner, Progen’s Vice President of Clinical and Medical Affairs will present a poster entitled “The Interactive Effect of Prognostic Factors and PI-88 Use on the Delay of HCC Recurrence Following Curative Partial Hepatic Resection” at the 58th Annual Meeting of the American Association for the Study of Liver Diseases in Boston, USA1 on Saturday, 3 November 2007.
The poster presentation will be made available on Progen’s website www.progen-pharma.com from approximately 9am (Brisbane time) Saturday 3 November 2007.
1Each 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 outcomes.
Link to poster preso. (for the science minded) <:))
http://www.progen-pharma.com/prs/AASLD%20HCC%20Company%20Poster_Final%20sec.pdf
Progen Update on Phase 3 Clinical Program for PI-88 in Liver Cancer
Friday November 2, 9:04 am ET
BRISBANE, Australia, Nov. 2 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL - News; Nasdaq: PGLA - News) today announced that in light of the recent Fast Track designation awarded to PI-88 for the prevention of tumour recurrence following curative resection of primary liver cancer and in order to commence the Phase 3 program as rapidly as possible, the Company will no longer continue with the Special Protocol Assessment process.
The Company has used the Special Protocol Assessment (SPA) process to obtain valuable FDA feedback on specific elements of our trial design. By incorporating this feedback into the trial design and with Fast Track designation for the assessment of delaying tumour recurrence following curative resection, Progen is confident that its Phase 3 trial meets the FDA requirements for approval under the Fast Track designation.
Justus Homburg, Progen's Chief Executive Officer, commented: "We will avail ourselves of the additional FDA access that the Fast Track designation affords us as we proceed towards trial completion. With the FDA feedback we have received to date and Fast Track designation, it is now time to lock trial design and prepare to commence patient recruitment."
The Phase 3 double-blinded placebo-controlled trial is scheduled to be run in countries in North America, Europe and Asia. Approximately 600 patients with post-operative primary liver cancer will be enrolled in the trial. The benefits of this trial design include the treatment of more patients than the Phase 2 program, which strengthens the clinical and statistical significance of the data. Patients will be treated for a longer period of time potentially prolonging the time to recurrence. The double-blinded, placebo-controlled nature of the trial will ensure the best possible data under the most rigorous of conditions.
We remain on track to enroll the first patient into the Phase 3 trial before year's end. An Asian investigators' meeting has been held in Thailand, the North American investigators' meeting is being held this week and one is planned for Europe in the coming weeks. In addition, key sites have submitted the protocol for ethics approval and regulatory submissions have been filed in key countries.
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 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.
http://biz.yahoo.com/prnews/071102/nyf037.html?.v=101
Thursday, 1 November 2007 -
PGL.AX closed up 10% @ A$2.86 (US$2.67)
Headline from the Australian Financial Review; "Street Talk"
Takeover talk takes over
Over in the biotech world it is still a far harder slog, with liver cancer drug developer Progen Pharmaceuticals losing a key supporter this week after AMP Capital Investors revealed it had ceased to be a substantial shareholder.
This is said to be a result of recent changes to AMP’s investment team.
Coincidentally, Northcape Capital, which has employed the departed AMP fund manager responsible for the holding (though he is yet to actually start) has emerged in recent days as a substantial shareholder in Progen, so it looks like the boutique fund manager is filling the void left by AMP.
Unfortunately Progen shares are now trading at $2.60, way back from the $5.74 price at which the company raised money in June and Progen’s price of more than $7 a share in May.
Investors are waiting for some newsflow with regards to a deal with a big pharmaceutical company, while clearly some aren’t going to be too happy if the price remains at current levels by the time the annual meeting comes around at the end of this month.
There has also been talk that shareholders are agitating for someone to buy the company (perhaps an Asian pharmaceuticals group), but maybe the situation will become clearer over the next month. Encouraging progress on Progen’s PI-88 drug made it on of the more closely followed biotechs by institutional investors (though not many are), but it looks as though that momentum has been lost.
Link to Progen poster presentation on the subject of:
“Heparan Sulfate Mimetics-Potent Angiogenesis Inhibitors for Cancer Therapeutics”
http://esvc000756.wic021u.server-web.com/prs/AACRposterOct07.pdf
Progen Presents Preclinical Data for Second-Generation Anti-Tumor Compounds at AACR-NCI-EORTC International Conference
BRISBANE, Australia, Oct. 23 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) today announced preclinical study results evaluating the anti-angiogenic and anti-tumor activity of the Company's new family of heparan sulfate mimetic compounds, known as the PG500 series.
Dr. Keith Dredge, Progen's Preclinical Development Manager, is presenting the data in a poster entitled, 'Heparan Sulfate Mimetics-Potent Angiogenesis Inhibitors for Cancer Therapeutics' at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, in San Francisco.
These studies evaluated the compounds' ability to inhibit new blood vessel formation in several in vitro models of angiogenesis. The investigators reported that multiple PG500 compounds, decreased or prevented human endothelial cell (HUVEC) proliferative responses to growth factors including fibroblast growth factors 1 and 2 (FGF-1, FGF-2) and to vascular endothelial cell growth factor (VEGF). Blocking these interactions inhibits the angiogenesis and metastasis processes critical in tumor growth and progression.
These compounds also prevented new blood vessel formation as determined in the rat aortic assay. In animal models of melanoma (B16F1 syngeneic mouse model) and human colorectal cancer (HT29 xenograft model), the heparan sulfate mimetic (HSM) compounds inhibited tumor progression. Progen has recently filed a second provisional patent application to cover these newer, more potent compounds presented at this conference.
Mr. Justus Homburg, Progen's CEO, commented: 'Clinical progress with our lead clinical candidate, PI-88, validates the principle of using HSMs as potent anti-cancer drugs. As we move forward in the clinic with this drug candidate, we continue to develop novel HSMs with properties that may extend and enhance their therapeutic applications.
'The data presented today support the continued development of selected PG500 compounds and the program is on track to file an investigational new drug (IND) application by end 2008.'
Progen's Drug Discovery Group is comprised of a multi-disciplinary team with expertise in medicinal chemistry, molecular and cell biology, analytical biochemistry, and molecular modeling. At the core of their research is an understanding of the role of carbohydrate/protein interactions that are implicated in the initiation and development of cancer.
About PG500 Compounds
PG500 compounds comprise a group of proprietary small molecule HSMs. Heparan sulfate proteoglycans play important roles in the normal physiology of cells, functioning to bind growth factors, extracellular matrix molecules and enzymes to specific sites on their sugar chains. HSMs act by blocking these interactions, thereby inhibiting processes such as angiogenesis and metastasis critical to tumor development and progression.
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
Source: PR Newswire (October 23, 2007 - 9:23 AM EDT)
News by QuoteMedia
Parabolic SAR Buy Signals (PGLA)
Title: Open Briefing. Progen CEO on PI-88 Fast Track
Date of lodgment: 28-September-2007
For access to Progen’s Open Briefing® - CEO on PI-88 Fast Track, please click on the link provided below.
http://www.progen.com.au/prs/CEO%20on%20PI-88%20Fast%20Track.pdf
or from
corporatefile.com.au
Record of interview:
http://corporatefile.com.au/documents/OB/CEO%20on%20PI-88%20Fast%20Track%2028.09.07.pdf
..
US FDA Fast Tracks PI-88 for the Treatment of Post Resection Liver Cancer
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.
Comments by Emerging Growth Capital following today’s announcements.
Progen Pharmaceuticals (ASX: PGL)[NASDAQ:PGLA]
Fast Track for Liver Cancer
Progen Pharmaceuticals have announced that PI-88 has been awarded Fast Track designation from the United States (US) Food and Drug Administration (FDA).
The major benefits of Fast Track designation are;
1) the option of submitting a New Drug Application (NDA) package in sections rather than as a single dossier,
2) scheduled meetings with the FDA to seek feedback on drug development plans, and
3) the option of utilizing surrogate endpoints for evaluation of efficacy.
We view the Fast Track designation awarded to PI-88 as highly favorable given the benefits.
It is particularly worth noting:
The option of submitting a New Drug Application (NDA) package in sections rather than as a single dossier. It is likely that all non-clinical aspects of the NDA submission will have been addressed by the time Progen is in a position to submit clinical data from the phase-III trial. This removes a degree of uncertainty from the review process and may save time (had additional or supplementary non-clinical data been required).
The option of utilizing surrogate endpoints for evaluation of efficacy. This is extremely important for the PI-88 liver cancer trial as the primary efficacy endpoint is disease free survival (DFS) i.e. not Overall Survival (OS). Oncology approvals issued by the FDA are, by-and-large, based on OS. Aside from being necessary to avoid a long trial, investors should note that Progen will be submitting an NDA based on the same endpoint that was headlined from the phase-II data set (i.e. DFS), where PI-88 extended DFS by 78%. This eliminates a significant degree of risk that is encountered when switching from a “time to progression” endpoint at phase-II to OS at phase-III.
In terms of time to market, we anticipate that the Fast Track designation should shave 6-odd months off PI-88’s review time (from approx. 12 – 18 months from submission to approx. 6 – 12 months). We also point out that while Fast Track designation is not related to the ongoing Special Protocol Assessment (SPA) negotiations, today’s announcement reflects an FDA-savvy approach by Progen; and also highlights the FDA’s impetus toward therapies for this unmet clinical need (i.e. post resection primary liver cancer patients).
Phase-II Data for NSCLC
Progen also announced that PI-88 failed to meet the primary endpoint of a phase-II study of the drug in non-small cell lung cancer (NSCLC). We have examined the summary data from the release, and make this comment;
As we noted in our distribution last week, this trial was an assessment of a therapeutic regime i.e. PI-88 and docetaxel (Taxotere, Sanofi Aventis). While addition of PI-88 seems to offer no clinical benefit to second line docetaxel treatment of NSCLC, there remains a possibility that PI-88 monotherapy (or in combination with another targeted agent) could be useful in treatment of the disease. Data from the phase-II may provide suggestive evidence for this -- a subgroup of patients treated with PI-88 monotherapy after ceasing docetaxel monotherapy survived significantly longer than those who did not receive PI-88 at all (median overall survival of 52 weeks versus 34 weeks).
In addition, it is important for investors to note that prospective oncology drugs often show activity in certain cancers but not others. This is exemplified by Nexavar where registration-worthy efficacy was generated in renal cell carcinoma (RCC) and advanced liver cancer, yet the drug failed a phase-III trial for advanced melanoma. We remind investors that PI-88 has shown very encouraging efficacy as an adjunct to surgery for primary liver cancer, as well as in advanced melanoma, and multiple myeloma.
Nonetheless --as previously emphasized-- we have not factored a commercial outcome from anything other than liver cancer into our valuation model for Progen.
As such, our valuation of A$16.45 [USD 14.30] per share remains unchanged in light of today’s data.
We continue to rate Progen as the most attractive ASX Biotechnology play.
My thoughts?
Word has it that institutions are now active buyers of Progen stock on ASX.
Once Progen agree with FDA on the phase3 design and the SPA is approved phase3 will commence and a lot of uncertainty will be removed and the price should act accordingly.
Currently way below the consensus of the main brokers who are following the company closely. Their valuations are between A$14-A$16 (~US$13)
With PGLA trading ~US$3 it is a gift to me and I have been buying more recently.
Please do you own DD before buying.
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