Arch Therapeutics Inc (ARTH)

[Regis999]

Japanese 3D Matrix and Arch Therapeutics

Here is the bottom line summary:

Initial Intellectual property came out of MIT for both. The purpose of both companies was different. The regeneration part is 3-D Matrix LTD. and the hemostasis is Arch.



In the video presentation below Dr. Rutledge said that when they first tested the peptide out they thought they had something great ! iT WASN'T !

Not satisfied with that Dr. Rutledge sought out the best minds in the peptide field, put some of them on the Arch board and now they have the best peptide formulas in the world. They patented the crap out of it with one of the best intellectual property law firms in Boston.

http://www.pabstpatent.com/

My research indicates that 3DM ran with the original formulations and thats why they are nothing close to the formulation of AC5.

Based upon intellectual property:

3DM = Building and Regeneration of organs
Arch= Stopping and Blocking

The Inventor

The common thread between 3DM and Arch is the inventor Dr. Rutledge



Arch patent strategy and MIT

Both Arch and 3DM have MIT exclusive patents pertaining to different areas. 3DM primarily relates to regeneration technology whereas Arch pertains to hemostasis. In both cases licensing fees must be paid to MIT as a few % of sales. Dr. Rutledge Ellis-Behnke laid out the general basis of Arch and 3DM in the interview in 2009 here:

http://www.pnas.org/site/misc/ellis-behnkePodcastTranscript.pdf


Presentation by Founder of AC5 Dr. Rutledge Ellis-Behnke PHD using AC5 on animals

AC5 Surgical HemostatTM is an Effective Hemostatic Agent in Anticoagulated Animals



You Tube Video --notice Dr. Rutledge discloses ownership in Arch but nothing for 3DM--notice mention of how primitive the first AC5 was (2006-07)

Dr. Rutledge Ellis-Behnke, PhD Linkedin BIO https://www.linkedin.com/in/nanomedicine

http://www.bloomberg.com/quote/7777:JP


Intellectual property

3DM = Building and Regeneration
Arch= Stopping and Blocking AC5 200+/- Applications

Background of two sister companies

3DM public company.
http://www.3d-matrix.co.jp

Very limited depth. Where is the Company investor presentation? CEO presentations?

Arch http://content.stockpr.com/archtherapeutics/media/a615ba3d0a9c00b0e77d846e84303000.pdf

Arch 2015 press releases 22

Arch press releases in 2014 27


3DM 2015 press release 6 (anyone read these??) 2014 ?

Where are all the video conference presentations for 3DM?

Dr. Terrence Norchi did Eight presentations in 2015

3DM zero.



Failed 3DM trial

First 3DM makes some very wild statements on their websites. Remember the key is who controls the intellectual property.

Here is a statement that in my opinion is not true—successful trials should mean approval by regulatory authority :

http://www.puramatrix.com/clinical_trials_hemostasis.html

"PuraStat® has completed a successful clinical trial in Japan. A clinical trial is being planned in the United States for PMA approval, and in Europe as post-marketing clinical follow-up studies"



My Comment IMHO FALSE !! Really???? We have to go back to 2010 to see when the “successful” trials ocurred. This is 2016. BTW the area of clinical trials do not conflict with the 200 +/- potential applications for AC5.

Japan Human Trials by 3DM:
3DM launched clinical trials in January 2010 for TDM-621 Clinical trials were completed in April 2011.


TDM-621’s hemostatic efficacy has been generally confirmed in clinical trials and tests five to seven days after surgery did not detect any problems. The product also received high praise by the doctors conducting the Japanese clinical trials. Based off the clinical-trial results, the company submitted a manufacturing and marketing approval application in May 2011 to the PMDA for TDM-621.

However, the PMDA has notified 3DM that it must provide stronger evidence for the efficacy of TDM-621, with more precise evidence on its hemostatic effects. In March 2015, the company withdrew its application for domestic manufacturing and marketing approval and has decided to restart clinical trials in Japan and reapply for approval. The company plans to commence clinical trials in April 2016.

Comment: So 3DM could not get regulatory approval in Japan in 2011 in their own country. 3DM is targeting totally different markets. 3DM has had some of their self assembly peptide patents since 2003 and the pace has been very very slow.

3DM CE Mark

One million $ question just how did 3DM get there CE Mark in Europe? It surely was not through human clinical trials or even animal studes. They could NOT even get regulatory approval in Japan. Where are the 3DM animal studies?



The 2-3 month CE Mark approvals that 3DM has obtained would be a layup for Arch IMHO. 3DM was forced into this mode because they have yet to be able to obtain regulatory approval for human clinical trials (even in their homeland of Japan).



Arch could easily have obtained this years ago. The problem with it is that it would only allow sale of AC5 for many of the 200 +/- AC5 applications. Arch decided they wanted to go for approval of the whole applications through human trials. This route maximizes market value of Arch in cutting future European distribution deals. No doctor would use Arch's products without human clinical trials. Read this sentence again.



Arch has followed very strict protocols before entering the human trials. Seems like every rat and pig has been tested with AC5. Many of the 22 press releases in 2015 and 27 press releases in 2014 covered these tests.Each animal test has scientific meaning behind them. Dr. Norchi has carefully calibrated all the animal testing with precision.



3DM Tortoise pace of product development

Remember that 3DM has self assembly peptide products intellectual property since 2003. It is almost 13 years and has had several setbacks such as not being able to obtain regulatory approval in their homeland of Japan in 2010/2011


The various 3DM websites indicate all kinds of activity but when you look under the hood there is very little going on:


“3DM negotiated sales agreements with multiple potential sales partners in Europe, but agreements were not concluded during FY04/15.”


Remember 3DM failed in getting Japan regulatory approval in Japan in 2011. In January 2014, 3DM obtained the CE mark for TDM-621, meaning it could sell or apply to register it without clinical trials in certain countries including Asia, Oceania and South America. Why have they yet to complete human clinical trials in Japan—2011 to 2015 ??


Between July 2014 and Mach 2015 3DM's hemostatic agent has been used in a total of 53 cases (53 CASES) since being certified as meeting the CE marking requirement in Europe, including 20 cases involving cardiovascular surgery. 53 cases in 9 months !!! They got their CE mark in January 2014. This is sloooooow !!


The tiny revenues that 3DM shows is mainly upfront payments for licenses to pharma companies or milestone payments. They talk about hiring sales people and rolling out sales on their website but nothing much has happened since the failed test of 2011.