what is happening with this company?, page-3

I don't know much about PGL but visit this thread occasionally.
Anyway, Nexavar (sorafenib) tablets from Onyx Pharmaceuticals, Inc killed PI-88?

This article is from Courier Mail dated 18/08/2008.

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Why did Progen axe trials of PI-88 liver cancer drug?
(http://www.couriermail.com.au/business/why-progen-axed-drug-trial/story-e6freqmx-1111117218034)

DRUG developer Progen Pharmaceuticals was pushing the message one May morning at a Brisbane biotechnology seminar that it wasn't a one-trick pony.

But at the breakfast seminar that day, who would have thought that Progen's top pony would be effectively dead within two months?

If anything, the mood then was jovial.

Progen managing director Justus Homburg grabbed laughs by showing a slide with the words "one trick pony".

He was trying to exorcise the notion that Progen was solely reliant on flagship liver cancer compound, PI-88 (on which it had spent more than $90 million and a decade of work).

Another slide depicted a herd of charging horses, suggesting Progen had a string of potential drugs.

But a reassuring presentation line, given as dozens of people finished off bacon and eggs on turkish toast, involved crucial final-round PI-88 tests.

Start of sidebar. Skip to end of sidebar.

End of sidebar. Return to start of sidebar.

"On track to meet trial completion expectations," it read.

Those expectations were shattered at a July 22 board meeting.

PI-88's trials had been axed after a review, Progen announced.

The move halved Progen shares in a day, angered investors and hurt confidence in management.

Now doubts are emerging about what killed the PI-88 trials or whether the death certificate could have been signed earlier.

It can be revealed one cancellation reason Progen gave – the onset of a rival drug's trials – had been flagged by a competitor months earlier.

Even then, the rival trial's dates indicate Progen may have had a head start of many years.

Progen has come far since a 1995 stockmarket listing and base in the blue-collar suburb of Darra.

It has raised $189 million and has new, smart headquarters near the Toowong Village shopping complex.

For more than 10 years it talked up PI-88, a carbohydrate agent containing sugars derived from a yeast.

It stops tumours growing or spreading. Potential targets included liver and lung cancers, and melanomas. Risk of failure, as for all biotechs, was a threat.

However, progress was detailed in annual reports depicting pictures of children and the elderly, and emblazoned with slogans such as "promoting life".

Progen also received kudos. "In Australian biotech investment circles, Progen is very well-regarded," Stuart Roberts of Southern Cross Equities wrote in 2006.

Investor sentiment seesawed. Progen shares topped $14.31 in 1997, then fell heavily but revived to $9.60 last year. Yet despite positively received results from a second-round PI-88 trial, the shares had slumped to $2.26 by November.

It later emerged investors had bought into Progen via margin loans with Tricom, so presumably margin calls further eroded the price.

Progen sharetrading was also subject to an insider-trading probe (thought to involve the client of boutique investment bank eG Capital). Bell Potter Securities is also thought to have been queried.

Both parties published bullish research and raised millions of dollars for Progen. eG Capital declined to comment while Bell would only say Chinese walls existed between its institutional and research arms.

Downside came at Progen when a prostate cancer trial, using PI-88 with another drug, stopped recruiting patients early due to side-effects. Progen lost market trust by downplaying this fact and playing up other results in February this year.

That same month, Progen bought California-based biotech Cellgate. The move widened Progen's drug pipeline but contained nothing as advanced as PI-88.

PI-88, coming in small vials with blue lids, was entering Phase III trials. These trials were make-or-break. For Progen, more than 600 patients would receive injections of PI-88 or a placebo in more than a dozen countries.

Timelines were slipping but Progen brushed off concerns.

The first patient, slated for 2007's last quarter, was recruited in March this year. The delay was due to "greater than expected impact from holidays over the past couple of months".

Another plus for Progen since August 2007 was the hiring of Quintiles, a leading contractor for trials.

Quintiles' presence and the constant recruitment reassurance have spawned market doubts about some public reasons for axing the trial.

That's because Progen now says recruitment was "slower than expected", as were regulatory processes in Korea, China and Vietnam.

Another major factor Progen blamed was the "recent launch of a competitive Phase III trial". That competitor is Nexavar, a drug made by Onyx and Bayer.

The rival has long been mentioned alongside PI-88, although Progen's ace was that Nexavar didn't target people who had undergone surgery for liver cancer.

But Julie Wood, vice-president of Onyx investor relations, says the company had been talking about plans to conduct a trial in that market "certainly from the beginning of 2008".

Such a Nexavar trial was registered on a US government test site in June.

Recruitment has yet to begin.

However, the estimated study completion date is for April 2014 (with a final data-collection date in November 2011). Progen's slated market launch was 2011-12, suggesting it might have years to grab a beachhead.

An argument from a source is a Nexavar trial further saps PI-88 recruitment. Consider a patient's choice. After surgery, would a patient rather a treatment involving needles (PI-88) or a pill (Nexavar)?

In a July interview with Biotechnologynews.net, Homburg highlighted the recruitment impact.

Homburg (who bought some $40,000 worth of stock in February) also denied any problems with patients already in trials, safety issues or effectiveness problems. That would presumably debunk questions about a safety issue emerging, or of trial protocol problems.

Yet the cancellation's timing raised theories about seemingly non-related announcements in the past six months. In hindsight, did they indicate problems had long been afoot?

These included Progen's purchase of Cellgate and an executive's departure.

The executive is believed to be overseas.

However, sources think his departure was only to accommodate an influx of Cellgate executives.

The market remains in the dark. "(Progen) have not provided a sufficient and satisfactory explanation for the termination of that trial," Bioshares analyst David Blake says.

Progen management last week cancelled an interview. A public relations representative later said the board was aware of issues that were "most valid". Shareholders should receive a "communication piece" this week, she said.

Progen still hopes for a regional deal on PI-88. It is considering mergers, retains $70 million in cash and has a new website picturing a man observing the sky. On the list of potential drugs, PI-88 gets no mention.
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Needles (PI-88) or a pill (Nexavar)?
Well...
But if PI-88 works better?
PGL should not have axed the trial in 2008?

Cheers