SSS - Stem Cell Theraputics - Page 6

I can't say I am shocked at the sell off (I was expecting a gap in one direction, up would of been ideal), and it doesn't help the market has gone to Hell in a handbag on the same day.

The NTx(R)-265 showed a drop of 6.3 NIHSS (this is good)
However there is something strange with placebo group scoring so high (-7).
If you had a stroke I doubt sugar water would help you walk away from it.
Sounds like they should be marketing this miracle water they used as a placebo...Just something to think about, before you push the sell.

IMO, This sets them back allot, and unless they can figure out what went wrong (FAST) i.e. faulty data recording or wrong protocol was followed, they will lose the warrants, and the backing of larger funds (I saw HSBC pulling some off the table today). It will not be good a good outlook near term. If that happens they might not be able to afford to do the test again with a burn rate of 1m / qtr. and 3 m in the bank. That equates to more PP's (dilution) down the road.

At this point you have the 3 options listed above. If you pick #3 then one option to make your losses back would be to move funds to a low risk ticker around this price range with good T/A and flip it a few times. Tough choice to make, considering this mess could just be a fat finger misprint. This might get cleared up without retesting... or... they could shelf it and move onto MS

GL

good time to go in or wait till tomorrow and see

Bioworld interview with CEO Alan Moore

http://www.pharmacychoice.com/News/a...icle_ID=584367


Despite promising data from an earlier midstage trial, Stem Cell Therapeutics Corp.'s stroke drug NTx-265, a combination of human chorionic gonadotropin and erythropoietin, failed to show a statistically significant improvement over placebo in a Phase IIb trial, sending shares of the Calgary, Alberta-based firm plunging 75 percent.

The stock (TSX Venture:SSS) dropped C30 cents to close Tuesday at C10 cents.

But it wasn't that the drug didn't work. Top-line data from the 96-patient Phase IIb trial, designated REGENESIS, showed substantial improvement in patients in the NTx-265 group, with a drop of 6.3+/-0.05 as measured by the National Institute of Health Stroke Scale (NIHSS). The problem was that the placebo worked slightly better, showing a drop of 7.3+/-0.9 NIHSS, results that surprised President and CEO Alan Moore, to say the least.

"You expect, of course, a placebo effect," he told BioWorld Today. "You always expect one. But we had expected a drop of 2 or 3 points at most."

Stem Cell Therapeutics will be rechecking dosages and blood levels to make sure those placebo numbers were correct. Meanwhile, it also will be analyzing results from several secondary endpoints, including the modified Rankin scale and Barthel Index. Those are just as important as the NIHSS scale and could offer clinical and regulatory paths forward if either or both yield positive data, Moore said.

"So the game isn't over yet," he added. "We're hoping one of the other endpoints will show something here."

Not that Stem Cell Therapeutics is the only firm to find stroke a particularly tough indication. Only tissue-plasminogen activator (tPA, sold as Activase by Roche AG) has gained FDA approval, but its use is limited and offers only a three-hour treatment window. Other products aimed at widening that window so far have been thwarted in the clinic, including San Carlos, Calif.-based Nuvelo Inc.'s recombinant direct-acting fibrinolytic alfimeprase and South San Francisco-based Renovis Inc.'s neuroprotectant NYX-059. (See BioWorld Today, Oct, 27, 2006, and Sept. 26, 2008.)

There are two Phase II-stage drugs currently looking for partners: Microplasmin, a truncated, stable form of plasmin from ThromboGenics NV, of Leuven, Belgium, and V10152, a recombinant human thrombolytic protein from Guildford, UK-based Vernalis plc. And Rehovot, Israel-based D-Pharm Ltd. recently moved into Phase III testing with DP-b99, a drug designed to competitively bind with metal ions to inhibit metal-dependent enzymes that are overexpressed in stroke.

But Stem Cell Therapeutics' NTx-265 is different from those clotbusters and neuroprotective agents. Hailed as a neuroregenerative drug, NTx-265 aims to replace brain cells that are lost or damaged by the stroke. Given to patients one to two days post-stroke, it's designed to stimulate the growth and differentiation of existing stem cells into functional neurons and direct motor, visual and cognitive recovery.

Data from an earlier open-label Phase IIa trial were promising. NTx-265 was found to be safe and showed improved clinical outcomes compared to published data on similar untreated stroke patients, as well as a trend toward reduced infarct volumes over time in comparison to previously published data.

The Phase IIb REGENESIS trial originally had been expected to enroll 120 patients, but the study was modified earlier this year after the firm was unable to recruit additional North American patients. The trial also had been placed on temporary clinical hold in 2008 following reports that 42 patients had died in a German study testing anemia drug Eprex (epoetin alfa, Janssen-Cilag) in stroke patients. (See BioWorld Today, Sept. 19, 2008.)

NTx-265 also is EPO-based, but Stem Cell Therapeutics has not seen any similar increase in mortality, Moore said. He added that further data from that German trial showed an imbalance of patients treated with tPA, so "we left tPA out" of the Phase IIb trial.

Theoretically, though, NTx-265 could be used with other agents such as clotbuster tPA, and Stem Cell Therapeutics might consider testing the two together in Phase III, he said.

An end-of-Phase II meeting is expected by the end of the year - around which time the company hopes to secure a partner for late-stage testing and commercialization - and for now, Stem Cell Therapeutics plans to keep moving the program forward.

"Everything before this said the regimen [of hCG and EPO] will work," Moore said. "So we don't think a spurious placebo effect means we should just walk away."

The company also is pursuing NTx-265 in traumatic brain injury in an ongoing Phase IIa trial. As in the stroke program, investigators again will be looking for signs of new neuron growth and direct functional recovery of motor, visual and cognitive capacity.

Stem Cell Therapeutics also has Prolactin, a regenerative treatment for multiple sclerosis. That program is set to start a proof-of-concept trial later this year.

The company, which has about C$3.5 million (US$3.27 million) in the bank, could pad its cash balance as warrants come due in June and October.

"That could potentially bring in a fair bit of money," Moore said, though, with only eight employees, the firm has been pretty successful in stretching its resources. Even with the full Phase IIb stroke trial ongoing, he added, the burn rate was only about $1 million per quarter.

im still hanging on to my holdings, (too much of a loss if i were to sell now). is there a chance in hell the SP will at least break .10 any time soon. or if its more wise for me to sell what i have and accept the loss.

do you guys think SSS finally found its bottom? around 0.08

Chart is broken... smashed. Overhead resistance will kill any strength it shows for months in my opinion. I'd sell half your position and take the loss now in case it continues to drop... keep the other half for a short time and sell into any strength. Sorry... just my 2 cents though.

Do your own dd, but ixs.v may be about to turn around. One of those definetly, maybe things.

thanks for the replies, i think ill wait it out for a bit, going on a two month vacation. once i get back ill sell at whatever price its at.

im done for a little while now need to work and save some money for my next entry into the market. will keep reading all the posts every day, knowledge is power. thanks guys

It is not wise to infer that the placebo arm benefitted; rather, we see that the active treatment arm had no effect. Moreover, never underestimate the placebo-effect. It works in mysterious ways.

The primary endpoint failed and unless a case can be made for a protocol violation, it will stay that way. Then again, even big pharma tries to save face by invoking secondary endpoints even while everyone in the room chuckles.

p.s., it was a saline placebo

and another one bites the dust, goodbye sss

expected sell off, can't imagine how ppl fell for the "waiting for more data from the placebo group"

yeah it's all over now!!!!
But if the results went the other way, it would of been sweet
We all knew it was a gamble (make or break on the results), and a very good gamble... looking at 2a data. For those following since Obama; we made alot of money off this one.
I somewhat feel bad the results did not turn out good.. it could of changed mankind as we know it. GLTA in the future

everyday new low lol
whats glta?

glta = good luck to all

thaks bro

Why is HSBC still buying this? I'm not trying to bring SSS.v back from the dead, I am just baffled and don't understand why HSBC would continues to purchase extremley large amounts of SSS.v.

bottom and kickback ...

Easy profit once a stock bottoms usually you have a small bounce or correction of the SP, they'll probably dump for 1 or 2 cents profit

Currently at 8 cents... any idea what's making this rise?

looks like it bottomed out on the weekly and the daily charts.
.07 resistance was broke last week.
IMO it looks like a good entry to see what the FDA has to say about phase2b

three months ago was an unfortunate SP drop due to the results of the placebo. However NTx(R)-265 regimen was successful of of reducing the NIHSS as intended and FDA will see this IMO



Stem Cell Therapeutics Corp. Announces Completion of Further Analysis of the Modified REGENESIS Stroke Data

CALGARY, ALBERTA, Sep. 9, 2010 (Marketwire) -- approximately 25% of the total - the NTx(R)-265 regimen had a statistically significant beneficial effect on the National Institute of Health Stroke Score ("NIHSS", the defined primary endpoint in the study), showing a mean reduction of 5.1 points for placebo vs. 8.6 points for NTx(R)-265 therapy. Additionally, in this subgroup, the effect of NTx(R)-265 was also statistically significant versus placebo on the secondary endpoint of modified Rankin and trended in favor of NTx(R)-265 for geriatric depression score, an important measure of "well being" in post-stroke patients.

Separately, in an analysis of the approximately 69% of patients who had one observer throughout the study versus multiple observers, all endpoints, primary and secondary, were in favor of the NTx(R)-265 regimen, although the effects were not as dramatic as that seen in the OT subgroup, and were not statistically significant. In the much smaller subgroup that combined criteria, OT plus a single observer, separation of drug and placebo effect was even more dramatic for NIHSS. Specifically, the NTx(R)-265 regimen reduced the NIHSS by a mean of 9.1 points whereas the placebo mean response was only 3.3 points, and again this difference was statistically significant.

Dr. Alan Moore, President & CEO of SCT stated "While these subgroup analyses were not pre-specified, they provide key information going forward with clinical evaluation of the NTx(R)-265 regimen, and in discussions with the FDA, on the importance of OT and one versus multiple assessors. Further, the OT findings appear to confirm the original mechanistic understanding of the NTx(R)-265 regimen - that it works by amplifying a natural process, the restructuring of neural functioning post stroke"

As stated previously, the Company continues to move forward as a biotech company considering a range of options, with management focusing its efforts on pursuing the end-of-Phase II meeting with the FDA for the NTx(R)-265 stroke therapy while concurrently reviewing alternatives for pursuing the traumatic brain injury ("TBI") and multiple sclerosis ("MS") study opportunities, as well as various external opportunities."

Looks like all the shorts have covered


Short Positions on 2010/08/31 1,900 -348,476 0.06

Sep. 3, 2010 (Market News Publishing) --
STEM CELL THERAPEUTICS CORP ("SSS-V;SCTPF-0") - Short Positions on 2010/08/31 1,900 -348,476 0.06

Net Total Last Total Price
Date Change Shorted Price Volume Range
----------------------------------------------------------------------------
2010/08/31 -348,476 1,900 0.06 9,472,359 0.06 - 0.08
2010/08/15 349,087 350,376 0.08* 6,660,374 0.06 - 0.08
2010/07/31 1,289 1,289 0.07* 6,288,433 0.06 - 0.09
2010/07/15 -94,250 0 0.06 5,538,459 0.05 - 0.06
2010/06/30 84,250 94,250 0.06 13,348,379 0.05 - 0.10
2010/06/15 6,886 10,000 0.09 20,830,544 0.09 - 0.10
2010/05/31 -68,820 3,114 0.11 59,721,331 0.08 - 0.48
2010/05/15 52,509 71,934 0.44* 7,162,082 0.37 - 0.49

* - Indicates that the closing price used is the last non-zero
closing price and is not the closing price on the report date.


Source: TSX