Expanded access for people like your grandmother should be a near term goal. With the first phase 2 datas in, the 0 to ~22 hour Multistem window can now be targeted for evaluted. However, this time frame is confounded by patients that recover on their own, so a large study size will be required to prove significance. A big pharma partner is needed, perhaps like the Icagen-Pfizer "6 PPS Partnership".
Sentiment: Strong Buy
Hypothesis: If Multistem is given too early, Multistem is cleared before the spleen response begins (~4-6 hr post-stroke).
The above hypothesis may be true If Multistem targets the spleen exclusively.
However, the peripheral immune response to stroke includes more than the just the spleen.
The reponse to stroke includes:
1. Microglia (resident immune cells of the CNS) within ~1 to 2 hours
2. Spleens and thymus within ~4-6 hours
3. Bone marrow within ~4-6 hours
4. Certainly there are other tissues as well...
So, if Multistem benefits microglia, Multistem should be given as soon as possible post-stroke. If Multistem is spleen specific, it should be infused absolutely no later than ~22 hours. Anything beyond this is folly.
Review Athersys patents for microglia, and you will find that Gil is now very aware of the early microglia response.
PATENT TITLE: MODULATION OF MICROGLIA ACTIVATION (Filing date April 1, 2014)
United States Patent Application 20140295442
Abstract: The invention provides methods for treating pathological conditions associated with an undesirable inflammatory component. The invention is generally directed to reducing inflammation by administering cells that modulate microglia activation. The invention is also directed to drug discovery methods to screen for agents that modulate the ability of the cells to modulate microglia activation. The invention is also directed to cell banks that can be used to provide cells for administration to a subject, the banks comprising cells having desired levels of potency to modulate microglia activation. Assignee: ABT Holding Company (Cleveland)
Changing the timeframe in the last phase 2 to include patients 48 hours post-stroke was a "Right Stuff" attempt to define the outer limit. This almsot killed us. Next time, lets give Multistem no later than 22 hours post-stroke. Ok Gil...Chugai?
Sentiment: Strong Buy
"The reason given for extending the window to 48 hrs (vs 24-36)..." "The reason given in the shareholder call was the cell processing labs go home at 5pm and Athersys was trying to finish a trial."
I am not sure this is the reason.
The change to include patients 48 hours post-stroke was made just one month after the trial began almost four years ago? The statements you mention about people asking why the trial was behind were made in 2013-2014, three year later.
The study start date was September 16, 2011 and the change to include 48 hours was made on October 24, 2011.
Changes to NCT01436487 on October 24, 2011.
Single infusion 24-36 hours following ischemic stroke
Single infusion 1-2 days following ischemic stroke
Sentiment: Strong Buy
This change (to include 48 hr post stroke) was made only one month after the trial started.
The trial was first received: September 15, 2011.
It would have been impossible to determine enrollment rate was too slow just one month after starting. I think they took a gamble to try to capture 48 hours for reimbursement and maximum target population for Multistem. It was a pure gamble.
Chugai will gamble Multistem works at early time window and take Athersys for peanuts.
This is just like the Icagen-Pfizer deal.
NEW YORK, N.Y., October 28 - Pfizer Inc. (NYSE: PFE) announced
today that it has completed its acquisition of Icagen, Inc.,
through the merger of its wholly owned subsidiary, Eclipse
Acquisition Corp., with and into Icagen. Icagen is now a whollyowned
subsidiary of Pfizer. Under the terms of the transaction,
each issued and outstanding share of Icagen common stock has been
converted into the right to receive $6.00 in cash, without
interest thereon, and less any applicable withholding and
On May 24, 2007, BTHC VI, Inc., a Delaware corporation, and its wholly owned subsidiary, B-VI Acquisition Corp., a Delaware corporation, entered into an Agreement and Plan of Merger with Athersys, Inc., a Delaware corporation and privately-held company. Pursuant to the terms of the Agreement and Plan of Merger, B-VI Acquisition Corp., which BTHC VI recently had incorporated in the state of Delaware for the purpose of completing the merger transaction, merged with and into Athersys on June 8, 2007, with Athersys continuing as the surviving entity in the merger. As a result of the merger, Athersys became our wholly-owned subsidiary and the business of Athersys became our sole operations. On August 31, 2007, Athersys, Inc. changed its name to ABT Holding Company, and BTHC VI, Inc. changed its name to Athersys, Inc. In June 2007, we also completed an offering of our Common Stock in a private placement. As a result, 2007 was a year of transition for us in terms of our compensation and benefit programs.
As of June 08, 2007, BTHC VI, Inc. was acquired by Athersys, Inc., in a reverse merger transaction. BTHC VI, Inc. is a shell company. The company was incorporated in 2005 and is based in As of June 08, 2007, BTHC VI, Inc. was acquired by Athersys, Inc., in a reverse merger transaction. BTHC VI, Inc. is a shell company. The company was incorporated in 2005 and is based in Argyle, Texas...Population: 3,561 (2013)
A shell corporation is a company which serves as a vehicle for business transactions without itself having any significant assets or operations. Some shell companies may have had operations, but those may have shrunk due to unfavorable market conditions or company mismanagement. Shell corporations are not in themselves illegal, and they do have legitimate business purposes. However, they are a main component of the underground economy, especially those based in tax havens.
Further, in August, 2007, Icagen entered into a collaboration with Pfizer for the discovery and development of novel pharmaceuticals directed against three sodium channel targets. The success of this collaboration led to the acquisition of Icagen by Pfizer in October, 2011. Icagen’s name was subsequently changed to Neusentis in early 2012. The talented Icagen scientists are now enabling the Neusentis Ion Channel portfolio.
LOL. You agree with 50% of what I say.
Athersys could make you rich, but it could also make you broke.
Athersys could merge for $6PPS, or it could become the next Genentech.
Multistem early infusion is effective, or Gil cherry picked the numbers.
Athersys extended to 48 hrs one month after starting the trial in 2011 because the infusion staff goes home at 5PM. Athersys messed up and Edison points out that late infusion probably will not work and it didn't.
They will chop shop the IP and stroke opportunity and throw the rest in Cuyahoga River on their way out of town.
Sayhay66.....Cleveland (sigh)...bad attitude...distracted
An alternative hypothesis is that Pfizer wanted to taint stem cells for UC to promote their own small molecule.
Pfizer Key Programs Registration / Phase 3
Xeljanz® (tofacitinib) – Ulcerative Colitis
Regardless, Pfizer designed the Multistem UC trial to fail because they knew Osiris required 4+ doses of Prochymal to provide therapeutic value.
Any way you cut it, Pfizer used Multistem with wreckless disregard for patients, and I am going on the record with this one. This study was beyond a reasonable long shot. One dose to treat patients is not responsible or fair to the patient. There is no excsure for this, especially without a multi dose followup option. Shame on Pfizer!
This is why small biotechs often generate the new technology.
They are often the smartest people in the room and do not have to deal with loud voices and poliitcs.
Lets see if Chugai can make a decision without loud voices and politics.