Anyone think we'll hear more from Robin/mgmt. on this? Hate to see it get lost late on a Friday afternoon! She needs to pound the drum!!!
Forget the XBI ... find some hidden gems in P2 trials! Go big or go home! NLNK has been a big winner and about to get bigger. CLDX from the $13's to over $20 in a week. And, for the patient investor, NBS just provided a great entry point as clarification from NBS mgmt. about trial design is emerging. Appears they changed the design ahead of release of data to include the findings as primary endpoint. They did NOT fail as Adam Fuerstein would have people believe! OT, but hey ... it's the weekend! GLTA
Hoping for the best for the people of Ferguson!!
Not much success? This traded at $13 prior to earnings! I'd say a 50% bump is pretty "successful". What are YOU doing "working" on the weekend? Wasn't the takedown on Friday enough for you?
We all knew it was a convoluted reaction and selling begat selling, with the help of the likes of AF and a short contingent! I do wish mgmt. had clarified the timing of the change in endpoints so that it was clear the trial did not "fail" the primary goal, at all. But, maybe they were counting on a more rational and well-informed audience. Biotechs are such easy prey for the shorts because of the binary nature of things. Hoping for a green week!!!
Patients who receive more cells get significant benefits. That’s a key lesson emerging from a clinical trial that was reported Nov. 17 at the American Heart Association meeting in Chicago.
In this study, doctors treated heart attack patients with their own bone marrow cells, selected for their healing potential and then reinjected into the heart, in an effort to improve the heart’s recovery. In the PreSERVE-AMI phase II trial, physicians from 60 sites (full author list) treated 161 patients, making the study one of the largest to assess cell therapy for heart attacks in the United States. The study was sponsored by NeoStem, Inc.
"This was an enormous undertaking, one that broke new ground in terms of assessing cell therapy rigorously," says the study’s principal investigator, Arshed Quyyumi, MD, professor of medicine at Emory University School of Medicine and co-director of the Emory Clinical Cardiovascular Research Institute. "We made some real progress in determining the cell type and doses that can benefit patients, in a group for whom the risks of progression to heart failure are high."
All participating patients received the standard of care -- stent placement -- and were only enrolled if, four days after heart attack and stenting, their ejection fraction (a measure of the heart’s pumping capacity) was less than 48 percent. The average starting ejection fraction was 34 percent, a sign of severe injury to the heart. After enrollment, patients had cells extracted from their bone marrow and received an intracoronary injection of sorted bone marrow cells or a placebo. Not all patients received the same dose of cells. Patients were supposed to receive a minimum of 10 million cells but some received more, up to 40 million.
Several previous studies of cell therapy for heart attack have used unsorted bone marrow cells. Bone marrow contains rare cells called endothelial progenitor cells, which are thought to promote healing and recovery of blood flow. In this study, extracted bone marrow cells were shipped to NeoStem’s facility and a marker for endothelial progenitor cells called CD34 was used to select progenitor cells before cells were returned for intracoronary injection.
Recovery and outcomes were assessed in several ways: MACE (major adverse cardiac events, ranging from hospitalization for chest pain to death), ejection fraction, measured by magnetic resonance imaging, and perfusion or blood flow in the heart, measured by SPECT imaging. Cardiac imaging was performed six months after treatment, and MACE came from an average of twelve months of follow-up.
MACE occurred in 14 percent of control patients (n = 83), in 17 percent of those of who received less than 14 million cells (n = 47), in 10 percent of those who received greater than 14 million cells (n = 31; this includes the next group), and in 7 percent of those who received greater than 20 million cells (n = 15). Mortality was 3.6 percent in the control group, and zero in the entire treatment group.
Displaying a similar dose-dependent trend, starting from an average of 34 percent, ejection fraction increased 4.9 percent in controls, 3.1 percent in the group receiving less than 14 million cells, 5.8 percent in the group receiving more than 14 million cells, and 10.2 percent in the group receiving more than 20 million cells. There were no significant effects on improvement in blood flow in the heart, as measured by SPECT imaging.
The patients who received treatment had delays in getting stents (average 931 vs. 569 minutes), which puts the treated group at a disadvantage in terms of the heart’s recovery. This was a chance effect resulting from randomization to placebo vs. treatment and not inherent to the treatment process, since all bone marrow-related treatment procedures occurred after stenting.
According to Quyyumi, FDA officials have told cell therapy investigators that MACE (clinical outcomes) are the important measure of success and SPECT imaging is not, although imaging provides information on mechanism. By this measure, in the group that received the most cells, the MACE rate was half that of controls. But comparing the placebo group versus the entire treatment group, there was not a significant effect on MACE.
Quyyumi says that additional follow-up should make the effect of cell therapy treatment on clinical outcomes even more clear: "It is encouraging to see clinically meaningful results this early in the study, and I look forward to future data readouts."
NeoStem executives have said that during the study, they were able to standardize their procedures so that in the future, every patient should be able to receive 20 million CD34+ cells. Quyyumi says the research team checked whether patients’ pre-existing levels of CD34+ cells in their bone marrow had a significant effect on their outcomes; they did not.
"If we assume CD34 positive cells are where the action is, it’s clear that you need big numbers," Quyyumi says. "This is a lesson for the cell therapy field moving forward."
Quyyumi is a member of NeoStem’s advisory board. This relationship has been reviewed and approved by Emory University School of Medicine.
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Nope, a 5'2" petite Swede!! Have a good weekend!!
Thanks, ack ... I'm a "dudette"! ;-)
There's no reason to repeat P2, and you know it! ZERO mortality!
The order of endpoints was changed, with MACE moved from a secondary endpoint to the primary safety endpoint ... completely safe and they will determine dosage based on P2.
Well, I took advantage of some uninformed traders in NBS today after a week of selling off, too. Bought back 2X my original position all under $3.75. Good news at end of the day, to boot! Have to know what you're buying!! Added a few TASR today, too!
We know NBS was the targeted by some nefarious group ... Today Robin stepped up. It's been an emotional week. Now is the time to put all of those cockroaches who infested the board on ignore and concentrate on a brighter, clearer picture. Hopefully, next week will begin the reconstitution of NBS for shareholders.
That there were millions of holders that couldn't wait to dump their shares for 5-10% below where they traded most of the week? SIX million in volume today? I'd say there was a lot of naked shares in the mix! Hadn't seen that volatility here for awhile. Guess it took some market manipulation to give some shorts the window they needed. If they didn't take it ... they're dumber than first thought!
Still was surprised we didn't bounce harder ... fighting invisible forces?
Do you really think that pr has been disseminated throughout the marketplace? If you are short and missed your chance to cover under $4 ... so sad! And, just realize that not EVERYONE is taking a beating on this thing. Over 2M shares traded today, many under $4 ... do you think they bought for a .10 gain like holywallst?
Was just thinking along those same lines ... what a week! Now, another weekend of anticipation wondering IF Robin can get this back on track with the marketplace. I'm not going to second guess timing of the announcement. If she was, indeed, out of the country, that might explain the delay in addressing the situation. They can't be happy about it, either! Work their tails off for years only to have the market kick them in the teeth on positive results! Let's see if the people who make the big bucks can pull this off?
People won't be buying the vaccine since it will be targeted to African countries, but the governments of those countries and international organizations will.
Sorry, kip ... sometimes I get confused reading these threads and think that it's my post that's being responded to. #$%$ format! No, I never bashed ... I did say that mgmt. made a mistake by having perfusion as endpoint, but other than that, I recognized what was going to play out and some of it was out of mgmt.'s control, clearly! It should get ironed out, but it's sure been unfortunate for a lot of people. GLTY
With all due respect ... I think your characterization of some of us who sold portions or all of our NBS when the market so clearly rejected, or didn't understand, the results, is unfair! You don't have to ride something down in order to be a "true believer". You know I have been in this for a long time, but the writing of what was happening was clearly on the wall. It's called capital preservation. I now own twice as many shares as I once had at a lower cost basis. If that, somehow, makes me disloyal ... so be it!! I hope it's the emotion that has taken hold of some people here when they write such things!
Because they have been in conversations with the FDA since results were out. I think the negative press barrage took them by surprise! At least they are trying to rectify it!