Who is hungry?, page-3

An article from Sept 2009 saying an IND was to be submitted one month after the article. Oct 2009.

No IND has been submitted after 5 years.

Were we lied to then?

If this drug fails we have another 12 to try says Rosen.

We can only make investment decisions on information provided at the time. But looking back with the history the  lack of outcomes is damning.

The article:

"

Delivering the goods: Phosphagenics' Harry Rosen and Esra Ogru.

DRUG delivery company Phosphagenics' trial using a chronic pain drug has demonstrated in a world first that the medication can be transferred into patients' blood through skin patches.

Completion of the trials at Royal Adelaide Hospital paves the way for the company to apply within weeks for investigational new drug status for oxycodone from US regulators.

Speaking in Melbourne yesterday, US-based chief executive Harry Rosen told BusinessDaily he intended to file an IND application in October and was confident the product's qualities would impress regulators.

Unlike earlier attempts to administer pain-killers through the skin in gels and sprays, Phosphagenics' matrix patches remove the likelihood of overdose or abuse by users because the drug is released in a controlled way.

"We are very excited about our results because we showed we could get the drug into the blood of all subjects without irritation to the skin," Mr Rosen said.

Only minimal amounts of the drug were used in the trials, therefore a therapeutic outcome was not registered.

"We were proceeding cautiously because it is the first time oxycodone had been administered in this way, but we will figure out dosing levels during the Phase 2 trials and we expect to complete them before the end of the year," Mr Rosen said.

Oxycodone, an opioid derivative similar to morphine, is one of the leading drugs for treating pain in cancer sufferers, taking in $US1.5 billion in sales.

But with oral delivery, regular dosing is necessary to prevent pain breakthrough in patients, according to Phosphagenics chief operating officer Esra Ogru.

"The results represent the potential of a significant breakthrough in the treatment of chronic pain," Dr Ogru said.

"Using our matrix patch, it will be possible to deliver the drug in a sustained way over three days, removing the peaks and troughs of pain relief delivered with oral treatment."

She added that because all opioids had similar molecular structures, it was possible that a successful oxycodone program could be applied to many other opioids in a market whose sales exceeded $US6 billion a year.

"We have a platform that is proven, so if one drug fails it is not the end for us because we can use that platform with at least 12 other drugs that we have tested," Mr Rosen said.

Mr Rosen established Phosphagenics with scientist Simon West in 1999 initially to manufacture vitamin E.

During research they discovered that vitamin E phosphates were able to penetrate the skin and coupling them with other compounds could lead to the development of cosmetics and therapeutics.

Phosphagenics shares closed unchanged at 11 yesterday.



COMMENTS