And, they don't leave trash and burned buildings behind, either!
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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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!!!
When you can't debate the real issues ... be sure to use inflammatory language and name-calling! Don't forget ... the R word! Racist this, racist that ... be careful, it is getting close to being "overdone", and thereby rendered impotent!
Easy ... Harry Reid refuses to vote on any bill, so the answer would be zero!! Harry Reid is an embarrassment to the entire country, not just Nevada!!
Speaking in Chicago on the news just now ... continues to say that the law is not levied out equally and that is where the frustration lies! OMG ... can't this narcissist shut his mouth and not inject himself into EVERY event?
That's what I was talking about ... this isn't a personal opinion piece by NBS mgmt. It is an "event" with top cardiac people weighing in! And, with insiders buying ... it's as good as it gets!
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.
Amazing how people need to thump their chest on some short term trade(s)! Yay!!! WHO hasn't done that ... and often you just end up chasing it back up unless you're doing it around a core holding! Vroom Vroom!!! Like I said yesterday ... she's got legs!!
Could have "drove" past? First of all, he should not have DRIVEN past because he received a call about a strong arm robbery when he happened upon the "victim" walking down the middle of the street carrying the stolen property (he even flashed it at Wilson when the "gentle giant" reached inside the officer's car) and matching the suspect's description. I don't know about you, but if I were in the middle of the street and a policeman told me to get on the sidewalk, I would comply. I suppose you would walk over to the officer's car, call him a #$%$ and then proceed to punch him, not once, but twice in the face? Oh, and then just to show a good attitude, you might then reach for his gun and try to wrestle it away from him? There are so many things wrong with this picture, you'd have to be blind AND dumb not to acknowledge them. What happens afterwards is a direct result of these! Get real!
Is this a speculative biotech? Absolutely! But, for those here claiming it is a sham/scam, whatever, is simply ludicrous. All one has to do is ask themselves ... just how does this "kachina doll company" get over all of those renowned medical clinics, teaching hospitals and doctors? Just how were they able to KEEP accessing financing (other than shareholders), albeit at very unfavorable terms that at least kept the science advancing? Now, finally, just how were they able to convince three top tier investment banking firms to front-run their offering? Things that make you go hmmmmm!!
YORK, Pa., Jan. 12, 2015 /PRNewswire/ -- Unilife Corporation (NASDAQ: UNIS and ASX: UNS), a leading developer and supplier of injectable drug delivery systems, today announced the appointment of David Hastings, a veteran finance executive with deep experience in the bio-pharmaceutical industry, as Chief Financial Officer. Mr. Hastings will be joining the Company on February 23rd and will report to Unilife Chairman and CEO Alan Shortall.
Mr. Hastings most recently served as Chief Financial Officer at Incyte Corporation between 2003 and 2014. Incyte, with a market capitalization of approximately $12.0 billion, is a leading biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs, primarily for oncology. Mr. Hastings played an important role in Incyte's evolution from early stage drug discovery into a financially robust commercial business with an FDA approved oncology drug and a strong clinical pipeline. During his time as CFO Incyte experienced significant increases in revenue and market capitalization.
During his 30 year career, including 15 years as a CFO in the biopharmaceutical industry, Mr. Hastings has held senior financial leadership roles at companies such as ArQule, Inc., Genzyme (now a wholly owned subsidiary of Sanofi), and PriceWaterhouseCoopers. He is a Certified Public Accountant.
Dennis Pyers, who has been with Unilife since 2010 will continue to serve as interim CFO until February 23rd, 2015, and will then remain at Unilife as Senior Vice-President and Controller reporting to Mr. Hastings.
Mr. Alan Shortall, Chairman and CEO at Unilife, said: "The appointment of David Hastings completes our goal to appoint a high-performance CFO with the deep business experience to support our rapid emergence as the global leader for injectable drug delivery systems. David's proven track record of delivering revenue growth, optimizing the balance sheet and maximizing shareholder value make him the ideal candidate to lead our financial strategy. In addition to welcoming David to our leadership team, I would like to thank Dennis Pyers for his excellent ongoing work since 2010, and for serving as interim CFO during this transition period," Mr. Shortall said.
Mr. Hastings said: "I am incredibly excited to be joining Unilife at this point in the Company's history. Unilife has built an impressive team of dedicated people focused on technologies that have the potential to optimize the delivery of injectable therapies. I share the Company's passion for improving the lives of patients, and in creating significant long-term value for its shareholders
Perception is often NOT reality! Buy the dips, my friend! You'll be glad you did!
I don't know what the he'll your problem is. I got that info from Investor Stemcell, of which I am a member. I thought it was pertinent to why the trial was being classified as a "failure" by some. I've been in NBS a lot longer than you have and I think you ought not be throwing the term idiot around so lightly. Just because someone isn't a Pollyanna and prefers to face reLity here, does not make them a basher or in cahoots with TheStreet!
Yeah ... With the millions of shares in volume, my, or anyone else's here, are sure going to move the needle one way or the other! Sheesh!!