The question is whether Multistem is effective against stroke-induced immunodepression and poststroke infections caused by splenic atrophy. The answer appears to be yes.
So, is the blood clot being removed?
When possible, most definitely.
What we are looking at is the effect of Multistem in addition to standard of care, which can include surgical clot removal using various devices (mechanical thrombectomy).
Go to the video, vimeo and 116559737. The doc clearly states this.
Yes, sorry, this post was a follow-up to some others I had made about imetelstat and breast cancer.
Basically, there is a recent 2015 pub showing imetelstat efficacy for HER2(+) in a combination therapy, and separately, MD Anderson shows another telomerase inhibitor enhanced by caloric restriction works for triple negative breast cancer. I suspect imetelstat would work similarly.
It looks like the failed HER2(-) study may be overcome.
"Taken together, our results suggest that the effect of BIBR 1532 is potentiated by GR to induce triple negative breast cancer cell death."
Imetelstat + Glucose Restriction
-Dr. Hait served as Associate Director of the Yale University Comprehensive Cancer Center and Director of the Breast Cancer Unit
-Dr. Hait is a member of the Medical Advisory Board of both the New Jersey Breast Cancer Coalition and Susan G. Komen Foundation
-He is an expert in breast cancer and is conducting basic research in signal transduction systems altered in malignancy.
Clin Breast Cancer. 2014 Dec;14(6):396-404
Trabectedin as a single-agent treatment of advanced breast cancer after anthracycline and taxane treatment: a multicenter, randomized, phase II study comparing 2 administration regimens.
Goldstein LJ1, Gurtler J2, Del Prete SA3, Tjulandin S4, Semiglazov VF5, Bayever E6, Michiels B7.
1Fox Chase Cancer Center, Philadelphia, PA. Electronic address: Lori.Goldstein@fccc.edu.
2Oncology/Hematology, East Jefferson General Hospital, Metaire, LA.
3Hematology/Oncology PC, Stamford, CT.
4Cancer Research Center, Moscow, Russia.
5NN Petrov Research Institute of Oncology, St Petersburg, Russia.
6Janssen Research & Development, LLC, Raritan, NJ.
7Janssen Research & Development, Beerse, Belgium.
"We found that imetelstat and trastuzumab combination treatment decreases the CSC (cancer stem cell) population, mammosphere formation, invasive potential, and tumor growth in vivo."
Breast Cancer Res Treat. 2015 Feb;149(3):607-18.
"The American Cancer Society recommends that all women newly diagnosed with breast cancer get a biopsy test for a growth-promoting protein called HER2/neu. HER2-positive cancer usually occurs in younger women and is more quickly-growing and aggressive than other types of breast cancer. The HER2 marker is present in about 20% of cases of invasive breast cancer."
-The New York Times
"For women with HER2(+) breast cancers, the drug Herceptin has been shown to dramatically reduce the risk of recurrence." -WebMD
"Imetelstat alone, and in combination with trastuzumab (Herceptin), decreases the cancer stem cell population and self-renewal of HER2(+) breast cancer cells." Breast Cancer Res Treat. 2015 Feb;149(3):607-18
"MENLO PARK, Calif., September 10, 2012 - Geron Corporation (Nasdaq: GERN) today announced that, on the basis of an unplanned interim analysis, it is discontinuing its randomized Phase 2 study of Imetelstat in metastatic HER2(-) breast cancer because median progression-free survival (PFS) in the Imetelstat arm was shorter than in the comparator arm." - Geron
HER2(+) Breast Cancer:
"In about 20% to 25% of breast cancers, the cancer cells make too much of a protein known as HER2/neu. These breast cancers tend to be much more aggressive and fast-growing." -WebMD
Each donor is also different. Beyond that required for safety, Athersys is probably not required to release all of its donor selection criteria. Athersys may also have some markers or pre-screens to identify particularly good donors in terms of desirable MAPC activity.
As you said, this is very different from small molecules generically made in India, for example, which can be shipped at wide ambient temperature ranges and easily assayed for purity and proper structure.
I also wonder about Athersys' contract with Lonza (Basel, Switzerland). Even if a patent expires, Lonza could maintain an exclusive contract with Athersys for the production of MAPC. In this case, it would require millions just to tool up and try to replicate the process with no guarantees.
For these reasons and the fact that Mesoblast/Teva and Roche have actively been pursing MSCs, a hostile takeover or hard negotiation with ATHX management for superior MAPC is prudent if the idea is to hedge. With other Multistem trials underway and multiple lines of data pointing in the direction of therapeutic value, 1.5 billion is no-brainer.
The Chugai deal is basically a signal telling everyone that if Athersys succeeds in Japan, it will suddently have the resources to put Multistem in production and build a giant PPS over nite.
If Multistem (MAPC) is the best, there is no "biosimilar" threat. Multistem would command the market like any therapeutic until its patent runs out and generics are produce.
Even after the patent expires, enhancements protected by additional IP that reduces manufacturing costs could undercut generics.
Most important, Multistem is poised to be first to market for stroke.
By my calculations, with the PCYC lesson fresh on big pharma's minds, we could face a hostile takeover in the coming days:
57 Institutional Holders with 7,681,755 Total Shares Held.
% of Shares Held by All Insider and 5% Owners = 19%
If Chugai Pharmaceutical Co., Ltd. gambled on Japan, it would be well worth the gamble of Roche to gamble on the rest of the world for a mere 20 PPS. Would you give your shares away for 20 PPS right now, risk free? Otherwise, Athersys could work with the FDA to gain early approval and quickly run beyond 100 PPS.
Pfizer would be left look at Roche like JNJ is looking at AbbVie which now owns PCYC.
Take a look at what Roche has been doing. Even if stroke fails, Multistem is something they would like to add to R&D considering Mesoblast and Teva are not stopping with their bone marrow cells.
"Modulation of mesenchymal stromal cell characteristics by microcarrier culture in bioreactors"
Roche Diagnostics GmbH, Penzberg, Germany
These findings may be useful for the generation of MSCs with tailored properties for clinical applications.
Thanks for all the comments. Its very interesting to think about. IMO, the bottom line appears to be that the "Golden Hour" is more like "The Fleeting 60 Minutes".
From WebMD - "Many people who suffer strokes have them while they are asleep, which may prevent them from getting clot-busting treatment in the critical first few hours after a stroke, a study shows.
Such strokes, referred to as wake-up strokes, account for about 14% of all strokes, according to the study. Previous research estimated the percentage of wake-up strokes between 8% and 28%."
Other reports link excess sleep with stroke...great something else to worry about while trying to go to sleep..."Could sleeping too much make you have a stroke? A new study indicates sleeping more than 8 hours a day can increase your risk by 46%."
1/3 of stroke patients miss the Golden Hour for meds or stents that help dissolve or remove blood clots.
Multistem meets this group's unmet medical need within a window of, hopefully 24 to 48 hours. While this is no substitute for missing the Golden Hour, Multistem can hopefully reduce/reverse a siginicant amount of damange caused by stroke-induced immunodepression caused by spleen atrophy, lung bacterial infection, etc. Simvastatin provides some of the benefits of Multistem but likely not all, Stroke 2013 Apr; 44(4): 1135–1143.
As for using Multistem 3 days (72 hours) following stroke, Multistem will need to be evaluted in another study because the current trial does not inlcude a 72 hour time point. The intervention of the current trial is a single infusion 1-2 days following ischemic stroke.
This is enough time for all pateints to make it into the hospital, so our market of helping patients is primarily this 1/3 of stroke patients.
'Golden Hour' Care Unlikely for One-Third of Americans
-Too few stroke centers sited in rural areas.
Even under an optimistic scenario, as many as 114 million people in the U.S. would be unable to reach a comprehensive stroke center (CSC) using ground transportation within the critical treatment "golden hour," researchers estimated.
Source Reference: Mullen MT, et al "Optimization modeling to maximize population access to comprehensive stroke centers" Neurology 2015; 84: 1196-1205.
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner
They have to. They are partners now. PCYC's terms and condition are now Abbvie's. The question is: Why did JNJ allow this happen? At some point, JNJ said no to PCYC.