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TOPIC: Spoke to Lestor at Okyanos

Spoke to Lestor at Okyanos 05 Feb 2014 09:35 #1296

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I was inquiring about the timeline for surgery.Still some months away.Being.held up by beauracracy
What was new is that a clinic could be opening as soon as March in the Netherlands.Our own Duckers or Druckers will be running the clinic.He said things move much quicker in Europe.
Got the feeling that it will be owned by Okyanos
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Spoke to Lestor at Okyanos 05 Feb 2014 10:19 #1297

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I think it is about time that I have a chat with my friend Matt again.

Thanks for the info Joey. :whistle:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Spoke to Lestor at Okyanos 05 Feb 2014 13:02 #1298

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I lived in Freeport Grand Bahama for 20 years and still have friends there. It's a quiet island that is legaly operated by a "Port Authority" through the Hawksbill Agreement established in the 1960's.There was always issues about revenues with the Government of the Bahamas and the Port. After Hutchison Whampoa built the largest deep water port in North America in Freeport another sphere of influence arrived. This Chinese company that is also involved with The Panama Canal and other large world projects definitely controls politicians.When I talked to companjy representatives at parties it was revealed that Li Ka-Shing made all the major decisions for Hutchison Wampoa and was well connected with the mainland Chinese.
He is listed as the richest man in Hong Kong.Other then Bahamian greed,the Chinese may also be causing Okyanos problems.
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Spoke to Lestor at Okyanos 05 Feb 2014 13:22 #1299

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Joey, thanks for the heads up on the possibility of a european clinic (Netherlands) ala Okyanos. Druckers is a consultant to Okyanos and appears to be active in many the major heart stem cell trials. Below is one such trial that came up on my radar and for which I could not find any mention on "clinicaltrials.gov".

www.tctmd.com/show.aspx?id=123373

Perhaps it is one of those Celution investigator led trials in the Cardio space which are being undertaken in stealth mode ?????? :KO:

It is fascinating to me that this trial is looking at the potential of repeat infusions of MSC at a time when single infusion is not yet approved.

As per the subtitle: RIPASSA: Same Strategy, Different Cells .............. is it reasonable to assume they are ADRC given that the REPEAT trial uses bone marrow cells? :winky:

"The multicenter randomized, placebo-controlled RIPASSA trial, which is enrolling up to 210 patients, aims to evaluate more definitively whether repeat intracoronary infusion of autologous MSCs provides a better outcome than single therapy. Participants must have stable CAD with refractory angina (Canadian Cardiovascular Score ≥ II) on optimal medical therapy and an LVEF of 35% or less."

Large european government sponsored trial aiming at sicker patients with LVEF of 35% or less ........ sicker than REPEAT patients.

Fas ..... or anyone else know what this RIPASSA trial is all about???? CC is holding the cards incredibly close to his chest.......... the only positive with this is that this type of secrecy is not normal in an overhyped pump and dump operation.

These low share prices have enduced me to buy more shares than I ever anticipated. This will mean that either I :bang: or I :vegas: .
NO MARGIN......... lesson learned years ago.
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Spoke to Lestor at Okyanos 06 Feb 2014 05:15 #1301

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Good try John- those conferences are always the right place to look, since the scientists love to share with their peers. :grin:

Anyway- the non fit is MSCs. Since Celution produces a heterogeneous population of cells nobody would call them MSCs, although they include them of course.

But RIPASSA appears to be effort only done in Holland and this picture is the stuff Eric Duckers was doing in 2012-



They probably culture the BM cells after the first treatment and give the patients a second shot after a while.
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Spoke to Lestor at Okyanos 06 Feb 2014 09:21 #1302

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Fas, thanks for the response.

I had seen that CVON slide in my quest for info about RIPASSA but assumed that the term MSC was used generically, instead of ADRC, not because they were using MSC exclusively but rather because the whole presentation was about collaboration between Dutch academic research institutes in the Cardiac Regenerative medicine space.

I made the association between ADRC and the RIPASSA trial because in the article I referred to there was a specific quote from Duckers that I felt was highly suggestive of a link ..................

''Henricus J. Duckers, MD, PhD, of University Medical Center Utrecht (Utrecht, The Netherlands), described a similar approach for the on going RIPASSA trial. As a rationale, he cited evidence that repeat cell administration may enhance engraftment, and that stem cell populations with different mechanisms of action may be better suited to treating later post-MI biological processes.''

The term ''stem cell populations with different methods of action'' YELLED ADRC to me. Perhaps I am wrong......... more than likely. If however Duckers has been undertaking an ADRC trial then I find it entirely reasonable for him to be aware of how this trial is progressing. If the trial is trending positive, then is it not unreasonable to believe that with positive data from a large study such as RIPASSA the Dutch government would proceed with the approval of the Celution ADRC treatment paradigm. They may well even be prepared to provide reimbursement. Who knows? :winky:

All of the above would provide some justification for Joey's comment about a specialised clinic being established in Holland with Duckers in charge. :nice: Time will tell.

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Spoke to Lestor at Okyanos 06 Feb 2014 13:39 #1303

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Yes John- time will tell.

Just one reminder- IntraVase approval came in early 2013 and without that approval loads of IRB and other approvals need to be obtained in order to start a intra-vascular study in the EU.

My guess is that the 9 "cardio-vascular" related- which could be on lungs, kidney and brain too- are/have been done in countries with more "liberal" regulatory requirements- prime candidate for me- India, maybe China- at least somewhere in that region with the exclusion of Australia. :winky:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Spoke to Lestor at Okyanos 06 Feb 2014 13:44 #1304

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fas wrote: Yes John- time will tell.

Just one reminder- IntraVase approval came in early 2013 and without that approval loads of IRB and other approvals need to be obtained in order to start a intra-vascular study in the EU.

My guess is that the 9 "cardio-vascular" related- which could be on lungs, kidney and brain too- are/have been done in countries with more "liberal" regulatory requirements- prime candidate for me- India, maybe China- at least somewhere in that region with the exclusion of Australia. :winky:


But - key I think is that Eric -if this materializes- opted for ADRCs, instead of a super-career as lead investigator in all kind of cardio-vascular studies- I believe he also is PI of the MI MSB trial- so a clear choice for the best tech. :woohoo:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Spoke to Lestor at Okyanos 06 Feb 2014 18:23 #1305

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Okyanos delays (whatever the reason ) ??? Thats like being surprised CC over promises...LOL... Shocking ! :evil:

A Duckers project in the Netherlands would certainly be interesting but I will believe it when I see it. Too many false starts to get excited until then for me.

Work going on in India ? Possible but so far officially there is silence in that country for a very long time.

Work in China would make sense given expected approval there by year end and I believe we have also had small hints from management in the past but we have always been more focused on Japan.

Otherwise...thanks for bringing up the topic Joey !!!

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Spoke to Lestor at Okyanos 17 Feb 2014 08:22 #1331

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There was a bit of a communication break-down- but I finally linked-up with Matt by phone today.

Subject to another meeting later this week in Holland with regulatory representatives, the plan would be to treat patients in Holland yes. But not in a special purpose clinic but at the University Hospital where Duckers is working now.

That is UMC Utrecht as we know now from the RIPASSA discussion.

We will know more soon I guess. :bye:

Okyanos themselves will take another few months..
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Spoke to Lestor at Okyanos 17 Feb 2014 11:36 #1333

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So a few more cases for the registery I assume.

Did you get any indication if these will be acute or chronic cardiac cases or maybe even both ?

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Spoke to Lestor at Okyanos 17 Feb 2014 13:35 #1334

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Would be a waste if those patients treated would NOT go into a registry I would think.
Helps to accumulate data which could be of benefit to future patients. It just would be contrary to present regulatory status- which is full fledged approval to treat chronic ischemia on an elective basis- with certain strings attached such as IRB or so.

This can only help to achieve reimbursement status quicker and in an efficient manner. Thereto if the interest into the Okyanos procedure is indicative, there will be plenty of takers i.e. demand for the procedure. :cool:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Spoke to Lestor at Okyanos 18 Feb 2014 09:56 #1336

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Fas, great news about potential rollout of the Celution procedure in CMI at Utrecht. :woohoo: As you know it was/is my belief that the RIPASSA trial utilizes ADRC. If the RIPASSA trial was initiated in 2012 then it is quite possible that they had preliminary safety and efficacy data already, particlularly given that the patient population was quite sick (LVEF less than 35%)

What is certain is that the regulatory authorities would not be considering a self pay procedure of this type in a major teaching hospital without significant proof that it works. I find it impossible to believe that these patients would not be tracked in a registry to monitor efficacy........... and potential future reimbursement.

Such a development in my mind puts us ahead of Mesoblast. The Dutch are famous for their value for money attitude. These trials are not being initiated on a "nice to know basis", they are being initiated and funded by the state because they offer "value for money" .

One day in the not too distant future the market will awaken to the potential. This is too big for BP to cover up. European demographics and healthcare budget deficits dictate that these treatments be adopted ASAP. :joy:
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