Phosphagen. Share Discussion Threads

[worc0670] 08/8/2007 09:29

Phosphagenics Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY) today announced the successful completion of its Phase 1b transdermal insulin trial. The positive results of this trial demonstrated that its TPM technology delivered insulin into the bloodstream in a non-invasive manner without causing adverse reactions.
The Phase 1b clinical trial, conducted at the Royal Adelaide Hospital by CMAX, an independent clinical research organisation, assessed the efficacy and safety of two improved TPM/Insulin formulations in 45 volunteers. Blood glucose, endogenous insulin and C-peptide levels were measured to assess efficacy.
The results for the lead formulation showed the blood endogenous insulin and C-peptide responses over time were highly statistically different in subjects that received the improved TPM/Insulin formulation when compared to subjects that received the placebo formulation. Similarly, blood glucose concentrations were significantly lower (p = 0.016) in subjects treated with the improved TPM/Insulin formulation. The effect of the treatment lasted for up to 8 hours after application of the gel.
Similar responses to TPM/Insulin were achieved in the 2006 Phase 1a trial, but as a consequence of the research to improve the technology, the Phase 1b results showed a more sustained effect and greater statistical significance.
Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said: "The Phase 1b trial showed that our TPM/Insulin formulation safely penetrated through the human skin and delivered insulin into the blood stream over a sustained period of time, without causing adverse reactions. The improved formulation demonstrated that we have made significant progress in our goal of delivering insulin through the skin in a non-invasive manner."
"We believe that these results are indicative of Phosphagenics' potential to provide the millions of insulin-dependent diabetics with a non-intrusive alternative to multiple needle injections each day," said Dr Ogru.
Phosphagenics intends to continue clinical development of its transdermal insulin. Preparations are underway for a Phase 2 trial to be conducted by CMAX at the Royal Adelaide Hospital under the guidance and supervision of Associate Professor William Hsu of the Joslin Diabetes Centre (Harvard Medical School) and Dr Sepehr Shakib (Director, Department of Clinical Pharmacology Royal Adelaide Hospital).
An application for the commencement of a Phase 2 trial has been submitted for ethics approval. The trial will commence as soon as possible following ethics approval. The Phase 2 study will be a single-blinded, placebo controlled, randomised trial, which will assess the pharmacodynamics and pharmacokinetics of transdermally delivered insulin using TPM technology in diabetic patients. The trial is expected to be completed by the end of the first quarter, 2008.
Phosphagenics is also currently in the process of compiling an Investigational New Drug package that would allow the Company to continue its Phase 2 clinical trial program in the U.S. after the completion of the Australian trials.

[spaceparallax] 08/8/2007 09:00

That would be nice.

[suesean1] 08/8/2007 08:44

News out in Aus, not been released here yet?!?

[ladybird1] 21/7/2007 09:24

Price normally follows Aus. Up previous day. No volume. Not significant.

[lgw] 20/7/2007 20:49

why the rise?

[fullbreakfast] 11/7/2007 09:33

donaferentes, there tends to be a time lag between ASX anouncements and the corresponding UK RNS coming out. You can sign up for e-mail updates on the Phosphagenics web site if you want to get the news more promptly.

[hopeless698] 11/7/2007 07:50

I hear about RNS's a bit earlier - shud come through soon, thought it would have been yesterday.

[donaferentes] 10/7/2007 19:40

Where is this announced?

[hopeless698] 10/7/2007 06:10

Phosphagenics Lists on the International OTCQX Market in the U.S.

[spaceparallax] 09/7/2007 10:30

Another positive step - we're definitely creeping in the right direction.

[hopeless698] 09/7/2007 07:19

Phosphagenics Phospha E Clinical Program


RNS Number:7901Z
Phosphagenics Limited
09 July 2007


Phosphagenics Limited


Phosphagenics and Nestle Nutrition extend option agreement


Phospha E(R) clinical program to progress as planned


09 July 2007


Phosphagenics Limited ("Phosphagenics") (ASX: POH; AIM: PSG; OTC/ADR: PPGNY)
today announced that it has, by mutual consent, extended the period in which a
commercial agreement is to be concluded with Nestle Nutrition ("Nestle"). In
January 2007, Nestle exercised its option to negotiate (on an exclusive basis) a
commercial agreement with Phosphagenics for the use of its Phospha E(R) to treat
and prevent metabolic syndrome.


Nestle has received regulatory approval of its acquisition of Novartis Medical
Nutrition ("Novartis"), substantially improving Nestle's position in the fast
growing and profitable healthcare nutrition segment. Gradual integration of
Novartis activities is planned during the next months. As Phospha E(R) would be
marketed by the extended Nestle enterprise, the acquisition of Novartis has the
potential to increase the value of the arrangement between Nestle and
Phosphagenics. In these circumstances, it was considered by both parties to be
premature to conclude their commercial arrangements before consolidation of
Novartis activities.


To avoid any delays in the development of Phospha E(R), Nestle and Phosphagenics
are continuing their planned clinical program, with the first human trial
intended to commence this quarter.


This clinical trial follows on from the successful completion of a series of
full dose-response pre-clinical studies of Phospha E(R). Nestle and
Phosphagenics are continuing to work together to develop Phospha E(R) for use as
a nutritional product, targeting the prevention and treatment of metabolic
syndrome.


Mr Harry Rosen, President and CEO of Phosphagenics said: "We are delighted to be
working closely with Nestle, the world's largest food company, with the aim of
bringing Phospha E(R) to market as quickly as possible."

[lgw] 23/6/2007 06:09

www.phosphagenics.com/BBY%20POH%20note%2020060831.pdf

Interestingly that in this document PSG mention the "blue sky potential" of other applications of other POH technology including oral drug delivery.

[lgw] 22/6/2007 22:58

Yes Donaferantes
simplistically there will be (imo) diabetics who will continue to inject (habits of a lifetime hard to change their routine etc)others will not be able to cope with transdermal patches ie may swim alot health or lifestyle not compatible, and others may not be able to take insulin orally.
The important point to me is that in the future diabetics may have a choice of delivery when today they do not.
Your post intrigued me because I thought why not swallow insulin? it is so obviously the way to go and therefore must have been considered for years.
Guess what! I found a research note previously overlooked(even though dated August) opinions appreciated.

I have posted below for those prepared to do their own research.

[ladybird1] 22/6/2007 14:31

As you say, could be a nasty for the transdermal insulin application, but the comfort I find with PSG, unlike so many other early stage companies in the field, is it's not a one product bet. To quote from yesterday's RNS

'Dr Esra Ogru, Executive Vice President R&D at Phosphagenics, said that this
trial shows the adaptability and flexibility of the Company's delivery
technology' and
'Phosphagenics' President and CEO, Harry Rosen, said: "As foreshadowed at ourAnnual General Meeting in May this year, we are very excited to be pursuing the dermatological and cosmetic applications of our technology.'

P{ity if the insulin application ultimately proved outmoded before it began, but the delivery technology is the basic asset.

[donaferentes] 22/6/2007 13:23

Big article about orally adminstered insulin in today's Times - sorry forget which page - possibly front page. Stomach acid proof capsules get through to the small intestine intact (so the insulin is not digested by the stomach's protein busters) and thnce into the blood stream to the liver. Seems to work well on limited trials so far. Could be direct competition for the transdermal version. I wonder who will get it to market first.

[rambutan2] 22/6/2007 01:03

Phosphagenics to Exhibit at Jefferies Healthcare Conference
8:44 AM ET Jun 19, 2007
MELBOURNE, Australia, June 19, 2007 /PRNewswire-FirstCall via COMTEX/ -- Phosphagenics Limited (ASX: POH) (AIM: PSG) (ADR/OTC: PPGNY) announced today that Harry Rosen, Chief Executive Officer, and Dr. Esra Ogru, Executive Vice President, will host a table-top presentation around the Jefferies Healthcare Conference at the conference reception being held at Per Se in the Time Warner Center in New York on Wednesday, June 27th, 2007 from 5:00 PM to 8:00 PM ET.

In addition, the Company will be available for one-on-one meetings during the week of the conference.


and short but sweet from the doc...

SkyNews Business Report - Dr Esra Ogru interview

31 May 2007
Phosphagenics' Executive Vice President, Dr Esra Ogru interviewed live on SkyNews Business Report Thursday 31 May 2007. To view the 3 minute interview in full please click here...

[rambutan2] 22/6/2007 00:29

the more one looks, the more excited one gets! a potential company maker in its own right.




and from our friends (?) in france...

[lgw] 21/6/2007 23:52

I agree Rambutan2 and Hopeless698. Retinol previously had to be applied in large doses to the skin to be effective, these concentrations caused aggravation and reddness - even leading to painful rashes :,consequentially cosmetic companies erred on the cautious side and decreased the qty of Retinol in creams rendering them pracically useless. PSG has comne up with a way of ensuring optimal absorption into the skin rather than causing topical aggravation.

This development is a bolt out of the blue for me an added bonus as I was expecting the next good news to be on the transermal insulin trials .

Shhh keep the secret.

[rambutan2] 21/6/2007 20:48

i think it looks fantastic news. the odds on psg turning into a multibagger get better on each rns. still, no doubt the mkt will go back to sleep until the next exciting development!

[hopeless698] 21/6/2007 18:59

There was a TV Programme on CH4 a couple of weeks back and virtually all these type of products were useless. If this really does work then this will make millions cos there lots of old looking birds living in this side of Yorkshire!

[lgw] 21/6/2007 16:11

This is one hell of a marketable product, all the major cosmetic companies such as Johston & Johnston L'Oreal, Estee Lauder etc, etc will be falling over eachother to get a more effective Retinol dermal application. Our aging population obsessed with finding a youthfull look spend millions on potions.

[spaceparallax] 21/6/2007 09:58

Good news.

[ladybird1] 21/6/2007 09:23

Thanks, Hopeless. The market seems pleased.