Dimerix limited (DXB)

http://dimerix.com/
BOUGHT A FEW OF THESE TODAY as i like the story and their fast track approach - Bought at 1.3c - Currently at Phase 11 trials and had some successes to date read on... some good volume of late leading into trial results

http://www.aspectfinancial.com.au/do...A==&popup=true

http://www.aspectfinancial.com.au/do...A==&popup=true

http://www.aspectfinancial.com.au/do...A==&popup=true

Dimerix announces outcomes of DMX-200 pre-IND meeting with the FDA

KEY POINTS:

 Path to drug registration in USA of DMX-200 in patients with chronic kidney disease (CKD)confirmed

 Path to the near term milestone of filing IND for the first US study(PK study) –no apparent road blocks or
extra costs identified at this stage

 DMX-200 to be treated as an adjunct therapy rather than a combination therapy–resultingin a much smaller
pivotal trial which is less expensive as it requires fewer patients

 Potential for approval from asingle pivotal Phase IIItrialwith single end point of improvement in proteinuria
from baseline
–bringing huge cost benefits over running two

Phase III trials
 Recognition of the importance of heterodimer pharmacology– validating the patented Dimerix technology in identifying new treatments


Who we are:
A clinical
-stage drug development company focused on commercialising new therapeutic treatments identified using our proprietary drug discovery platform.
Discovery Platform:
Receptor-HIT technology to identify clinical opportunities from drug-receptor interactions, and potential revenue generation.

Lead Program:
A therapy (DMX-200) currently in Phase II clinical trial for Chronic Kidney Disease (CKD) and US Orphan Drug Designation for Focal Segmental
Glomerulosclerosis (FSGS).

Leadership:
Commercially focused and experienced board and management with a record of hitting milestones and creating significant shareholder value.
Key Assets 3
•Pre IND meeting with FDA held 29th June 2016
•Therapeutic use patent granted in USA 19th April 2016

JUST RELEASED 5 MINUTES AGO - should move significantly soon - Ill give it 24-48 hours once the wider investment community get wind of this :D

http://www.nextbiotech.com.au/dxb-cl...%20KNOW%20MORE

"The good news for DXB is that with its work validated by the FDA, it now has a smooth development path to lead into Phase III trials."

"

FINALISED: 16-08-16 PUBLISHED: 16-08-16
DXB Close to Phase 2 Results: Progresses Promising CKD Product

Dimerix (ASX: DXB) has just completed its “pre-IND” consultation with US regulatory body the Food and Drug Administration (FDA) with some encouraging outcomes reported.

The big news for DXB is that its intended Phase 3 DMX-200 trial will be positioned as an adjunct therapy and not a fixed dose combination therapy.

In other words, DXB’s DMX-200 trial will be completed by adding one drug to patients on the existing standard of care. Many patients are already taking an angiotensin II type I receptor blocker, which is registered in the US for treatment of high blood pressure and diabetic nephropathy, a disease of the kidney, and the trial will add a chemokine receptor CCR2 blocker, used for its anti-inflammatory properties, to this routine treatment.

This confirmation is a key development for DXB — not only could this significantly de-risk the DMX-200 trial, but equally importantly, will drastically reduce the time, effort and cost required to progress DMX-200 through to final approval and end-user sales.

Remember, however, that this is still an early stage biotech company and anything can happen, so remain cautious when considering adding this stock to your portfolio and seek professional financial advice.

All in all, DXB’s ambitions have been well and truly validated by the FDA which now leaves DXB with a smoother and less fraught development path. A key caveat for DXB is that “substantial further investment should not be required before filing the Investigational New Drug application (IND) for the first US study, known as the PK study”. When a budding young company is told it doesn’t require substantial additional funding, that tends to be a good measure of progress.
Stage 2 results are also imminent for DXB — currently expected around October 2016 at the latest.

In terms of R&D, it’s so far, so good for DXB:

Investor Update

With research and development neatly taken care of, further validation comes in the form of the Novartis Prize — an annual award by the British Pharmacological Society which has recognised DXB’s Chief Scientific Officer for his work on DMX-200.

This multi-award winning molecular pharmacologist has been recognised by academia which is superb for the academic sciences…
…but it’s the recognition from DXB’s Board that could make all the difference for DXB investors, and chronic kidney disease sufferers.

With Professor Pfleger as DXB’s Chief Scientific Advisor, and positive progression of its clinical programs, means DXB’s underlying discovery engine can be further developed to generate new opportunities.

With all that and more (including a new DMX-250 variant that will focus on treating Non-Alcoholic Steatohepatitis (NASH)) we’re back to re-sync our readers with DXB’s story — a budding early-stage pharma company aiming to become a rapid biotech growth story that leverages modern lifestyles."

Yet another article about DXB and their CKD technology platform - i have a gut feeling they will breeze theough stage 11 clinical trials and have a clear passage through FDA according to this interview

http://finfeed.com/biotech/dxb/searc...iams/20160329/


Chronic Kidney Disease, otherwise known as CKD, affects an estimated 26 million people in the US alone. As scientists working in medical-based companies strive to find cures for CKD, it seems we are slowly moving closer to combating this serious problem.

One company working hard in this space is Dimerix (ASX:DXB).

Dimerix is an ASX listed $8 million capped biotech company that has two major assets helping it deliver a global solution to kidney disease.

Jonathan Jackson spoke to Dimerix Executive Chairman James Williams about the rise of CKD, the industry and the assets DXB has that could solve the problem.
Finfeed (FF): James, you have been involved with biotech companies previously, can you give me a brief history of your time in this space?

James Williams (JW): I started out in academic medical research, with a PhD and 6 years as a post-doc researching the molecular and cell biology of kidney disease then cancer. I got interested in the translation of medical research, completed an MBA, and was hired from there into the biotech industry in 2000.

I soon ended up as Managing Directory of Argus Biomedical where we took an artificial cornea through FDA, CE Mark and TGA approval before launching it. I then ran Resonance Health (ASX:RHT) where we again secured FDA, CE Mark and TGA approvals for their MRI-based diagnostic for liver iron levels.

Patience required with DXB - results of trials due Late September early October :)

I've been looking at this briefly for a little high risk/high reward game based on my internal and unproven Hotcopper post amount rule. I know nothing about Biotech but have gambled in the past on other stocks purely on buy when posts are low and sell when folks call it the next big thing.

Btw the title has the wrong ASX code in the title if you can change it.

Sorry cant change title - DXB everyone :)

its worth a punt considering they at stage 11 trials - high risk and only worth no more than 5% of your working capital IMO which is amount ive invested in - we will know in October if successful

Quote:

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Originally Posted by SCHUMACHER

Sorry cant change title - DXB everyone :)

its worth a punt considering they at stage 11 trials - high risk and only worth no more than 5% of your working capital IMO which is amount ive invested in - we will know in October if successful

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I think if you edit the first post you can change the whole titel.

Quote:

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Originally Posted by silu

I think if you edit the first post you can change the whole titel.

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thanks Silu - wasnt aware i could do that until i found advanced settings- its now got the correct ticker on first post :)

Had been in trading halt but resumed today after this announcement..
https://www.directbroking.co.nz/Dire...spx?id=5376057
Now up 67%