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TOPIC: Ovarian Cancer

Ovarian Cancer 16 Nov 2017 07:07 #10556

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Press release this morning - CYTX reports Bioequivalence Trial Results in Ovarian Cancer at AAPS !

PS - could not copy release.

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Ovarian Cancer 16 Nov 2017 07:16 #10557

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rodney.strongg wrote: Press release this morning - CYTX reports Bioequivalence Trial Results in Ovarian Cancer at AAPS !

PS - could not copy release.


Copying is rather easy, assuming you know how to.

SAN DIEGO, Nov. 16, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today announced the results of its pharmacokinetic bioequivalence trial of ATI-0918 (test product) and European sourced CAELYX® (reference product). ATI-0918 is being developed by Cytori Therapeutics as a generic formulation of Janssen’s CAELYX® and Sun Pharma’s Lipodox®, liposomal formulations of doxorubicin hydrochloride marketed internationally and in the U.S., respectively. The data was presented this week at the American Association of Pharmaceutical Scientists Annual Meeting held in San Diego and the abstract is available online .
The pharmacokinetic bioequivalence trial was designed as a single-blind, randomized, two-way, crossover bioequivalence study. Ovarian cancer patients were randomized in a 1:1 ratio and received one of two treatment sequences. Each sequence consists of two treatment cycles, 28 days per cycle. In Sequence A, patients received a single dose of 50 mg/m2 European sourced CAELYX® on Day 1 of Cycle 1 and a single dose of 50 mg/m2 ATI-0918 on Day 1 of Cycle 2. In Sequence B, patients received a single dose of 50 mg/m2 ATI-0918 on Day 1 of Cycle 1 and a single dose of 50 mg/m2 European sourced CAELYX® on Day 1 of Cycle 2. There was a 3-week wash-out period between Cycle 1 and Cycle 2. The number of patients used in the bioequivalence assessment was 44.
In summary, the pharmacokinetic bioequivalence of ATI-0918 was confirmed as bioequivalent to European sourced CAELYX®. The lower and higher 90% CI ratios for ln-Cmax, ln-AUC0-t and ln-AUC0-inf of free doxorubicin, encapsulated doxorubicin and the metabolite doxorubicinol following ATI-0918 were within 80.00% to 125.00% of those ratios following European sourced CAELYX®.
ATI-0918 is a complex generic formulation of the market-leading oncology drug, DOXIL®/CAELYX®, which is FDA approved in the U.S. for ovarian cancer, multiple myeloma, and Kaposi’s Sarcoma; and in the European Union for breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s Sarcoma. The current approval pathway for ATI-0918 is to leverage existing bioequivalence data to CAELYX® for approval in the EU and to demonstrate bioequivalence to Lipodox® in the U.S. The global market potential for liposomal doxorubicin is expected to grow to $1.4B by 2024 and Cytori is actively seeking commercial partners for its ATI-0918 asset.

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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:

Ovarian Cancer 16 Nov 2017 07:20 #10558

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You guys beat me to it...LOL

Well they certainly are trying to keep this supported.

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Ovarian Cancer 16 Nov 2017 07:24 #10559

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Excellent data.

This is a very difficult study and yet it is well done.

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Ovarian Cancer 16 Nov 2017 07:27 #10560

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Franshei, encouraging release.

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Ovarian Cancer 16 Nov 2017 08:20 #10562

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This study would be acceptable for a partnership talk. The San Antonio pilot plant (plus the analytical lab) has been validated (together with the HPLC system) and it is being scaled up for commercial scale production. The next step is compounding and stability testings (going hand in hand with HPLC assay).

Unlike cell therapies, ATI 0918 would be widely acceptable.

Remember Geron, they has no problems to find money for their drug venture, yet they hit stonewall with their embryonic stem cell therapy. In the case for CYTX, celution system as a medical device in selective (niche) applications will still live on. Outside of CYTX, physicians know the applications better.

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Ovarian Cancer 16 Nov 2017 09:52 #10563

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Rodney

I think as long as the PPS for CYTX is higher than the RO conversion price for stock, people will "rush" to buy the RO. People like bargain.

In the future, there maybe 3 market places for the cytori traders: CYTX, CYTXS and CYTXW. CYTXW may become virtually inactive.

To drive the stock price higher to avoid a reverse split, we need solid news. We may have time, as long as the company could avoid stupidity and give us carrot (real meat and carrot).
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Ovarian Cancer 16 Nov 2017 10:02 #10564

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Rodney

The next news item that may come through the wire is phase 1 data for lipo taxo. My understanding is that this phase 1 trial is completed and the drug has clinical activity in non small cell lung cancer. December 1 is the deadline for submitting an abstract to next year's ASCO. Maybe thee is an abstract coming. This data may or may not have presented before. Another place for such an abstract is EROTC.
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Ovarian Cancer 16 Nov 2017 10:19 #10565

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Burn....................re copy and thanks for keeping board alive.

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Ovarian Cancer 16 Nov 2017 10:27 #10566

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franshei wrote: Rodney

I think as long as the PPS for CYTX is higher than the RO conversion price for stock, people will "rush" to buy the RO. People like bargain.

In the future, there maybe 3 market places for the cytori traders: CYTX, CYTXS and CYTXW. CYTXW may become virtually inactive.

To drive the stock price higher to avoid a reverse split, we need solid news. We may have time, as long as the company could avoid stupidity and give us carrot (real meat and carrot).


Franshei, totally agree.

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Ovarian Cancer 16 Nov 2017 10:35 #10567

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Franshei
I agree on the "real meat" news item comment but then you post about a possible phase 1 data release ?

Have we learned nothing about the value of such releases ? !!!!

I also felt that lowering the warrant buyback option sub $1 was not a bullish sign. Especially in terms of the possibility of a R/S.
Otherwise, I agree on your comments about retail loving a bargain...even if it's two cents and despite what artificial propping may or may not occur.

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Ovarian Cancer 16 Nov 2017 11:07 #10568

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myownhedgefund wrote:
Franshei


I also felt that lowering the warrant buyback option sub $1 was not a bullish sign. Especially in terms of the possibility of a R/S.


HF, you keep talking about a RS - we are all aware of that, but do you know how long CYTX could likely go before that decision has to made??? It is a while, isn't it?

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Ovarian Cancer 16 Nov 2017 11:18 #10569

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Of course, we are all aware, or at least should be. Just as everyone should be aware they were turned down last time when they asked for a extension.
All we know for sure is the issue will be at the forefront in the not to distant future.

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Ovarian Cancer 16 Nov 2017 11:26 #10570

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I'll add one more happy point.
With yesterdays price changes the conversion now has increased dilution from approx. 76% to 90% !!!!
That's BEFORE you take into account 18 million warrant shares.

Oh Happy Times !!!!

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Ovarian Cancer 16 Nov 2017 12:00 #10571

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myownhedgefund wrote: Of course, we are all aware, or at least should be. Just as everyone should be aware they were turned down last time when they asked for a extension.
All we know for sure is the issue will be at the forefront in the not to distant future.



HF, get your facts straight - in June 2015 CYTX was notified by NASDAQ re the $1 issue with 6 months to correct in Dec., 2015 - a hearing with the SEC granted them a six month extension to 5/31/16 - in the current case, CYTX was notified by NASDAQ on 9/5/17 and has until 3/5/18 to comply - no reason that a hearing will not give them another 6 months as in the prior year - do not forget that CYTX has a US government relationship through BARDA that certainly does not hurt the situation for an extension request.

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Ovarian Cancer 16 Nov 2017 13:28 #10572

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1 for 2 Rodney
Yes March 5th...I keep counting from the big STAR failure day in July....score one right
No, there was another attempt for a extension (news just around the corner) that was denied and the R/S then happened...score one wrong.
BARDA...that's a good one !!!
The massive dilution that was just made even more massive remains a fact !!!

Lets assume a partner does come...you don't think they will be getting shares as well ?
Green Hospitals got shares
Astellas got shares
How about Olympus ?
We know that poor guy in China got stuck with shares that he dumped.
Even Azaya got shares in their buyout.

No matter the course...R/S, yes or no...more dilution follows this raise.

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Ovarian Cancer 16 Nov 2017 14:56 #10573

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HF, I assume that you are talking about a second extension the last time which would be unusual and would have resulted in a one and a half year period of non-compliance - I do not recall that - Fas, do you recall?

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