1. Mesenchymal Stromal Cells for Ischemic Stroke (SAMCIS) Phase 1 & 2
ClinicalTrials.gov Identifier: NCT01922908
Sean Savitz, The University of Texas Health Science Center, Houston
Study Start Date: July 2015
***When given between 3-10 days after an ischemic stroke
2. Cord Blood Infusion for Ischemic Stroke Phase 1
ClinicalTrials.gov Identifier: NCT02397018
Joanne Kurtzberg, MD, Duke University Medical Center
Study Start Date: May 2015
***The cord blood infusion must be given within 3-10 days of the stroke.
3. Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke Phase 1 & 2
ClinicalTrials.gov Identifier: NCT01849887
Steven C. Cramer, MD, University of California, Irvine
Study Start Date: January 2017
***Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated
4. Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke
ClinicalTrials.gov Identifier: NCT02290483
Andalusian Initiative for Advanced Therapies
Study Start Date: April 2015
***Time of stroke onset is known and treatment can be started between day 1 and 7 of onset.
You are calculating to capture the entire MF market. This will never happen. Ok, for fun, double my estimate to $150 million annually for Geron at peak sales world-wide at 15% royalty. Maybe a wee bit more at 20%. Geron still has way too many shares out. 10 PPS is generous until more indications come online. Before this happens, GERN will be bought out. "JNJ gave 3 different diseases to use GERN drug on. -jkokao". This is how its going down. Buyout at 15-20 PPS?
The current trial is "Previously Treated With Janus Kinase (JAK) Inhibitor". This means Geron/Janssen will treat those patients whom oral JAK inhibitors are not working.
End of story.
Geron needs other indications to make it big time. As cited above imetelstat for pancreatic cancer, etc.
True, BLUE may turn out to be a dud if it is not safe.
But, if GERN is successful for MF, it is a 10 PPS stock.
There are about 10,000 patients with MF worldwide that will take imetelstat, representing a ~$500 million market. Tiered royalties ranging from a double-digit up to mid-teens percentage rate on worldwide net sales is $75 million annually. Geron would need to co-promote if it wants more.
Imetelstat a hypertension drug...I doubt this very seriously because of the effect on liver. Unless low dose works really well, which it might? All indications are a wild card except oncology. We need firm movement toward oncology beyond MF. Solid tumors. Difficult cases. e.g. "Telomerase Inhibitor Imetelstat (GRN163L) Limits the Lifespan of Human Pancreatic Cancer Cells"
Until we see some serious movement toward other oncology indications that immunotherapies prove ineffective, 10 PPS is the ceiling here.
GERN does not have the potential value of BLUE with MF alone. It will never have the same market cap unless other major imetelstat indications are put on the pipeline by Janssen(JNJ).
GERN is heavily diluted and drowning in 158.09M shares.
GERN share numbers should be more in the range of a BLUE with 32M shares. Just taking a moment to reflect on this and how richly priced GERN is with almost 5X the number of shares as BLUE with much less current prospects.
GERN is currely valued correctly...and a little rich at that.
Wrong, JNJ touted that abiraterone was a "wonder drug" for prostate cancer in order to take Provenge off of the market.
The truth is, abiraterone does not work:
"For the abiraterone phase 3, the median overall survival for was 35.3 months for the group of men who received ZYTIGA® (abiraterone) plus prednisone, compared to 30.1 months for the group of men who received placebo plus prednisone. This difference, however, did not meet statistical significance." This is directly from Janssen (JNJ).
Now, Provenge is gone.
Severe Sepsis is a potentially life-threatening complication of infection where the whole body is subject to an inflammation caused by bacteria, fungi, viruses or parasites. If sepsis progresses to septic shock, blood pressure drops dramatically, which may lead to death. Patients with severe sepsis require close monitoring and treatment in a hospital intensive care unit.
As a proof-of-concept study, TiGenix initiated in December 2014 a phase 1b trial to test the mechanism of action of Cx611 in this indication. The trial is a randomized, placebo-controlled trial in which healthy volunteers will be challenged with a bacterial endotoxin to induce sepsis-like clinical symptoms. Results are expected in Q3-2015.
Sepsis is an affection of complex nature and its variable presentation has made it hard to develop therapies. Cx611 could be added into current clinical management, representing a good therapeutic and commercial opportunity in an unmet clinical need.
TiGenix initiated in 2014 a phase 1b trial in severe Sepsis treated via intravenous injection of allogeneic stem cells (codename: Cx611). The company intends to launch a phase 2b trial in early RA in Q3-2015.
Celgene will gain six-month right of first refusal on Mesoblast’s stem-cell product candidates for conditions including...certain oncological ailments.
Highlights (Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis
Volume 768, October 2014, Pages 98–106):
•MSCs exert stimulatory or inhibitory effects on tumor growth and invasion through direct or indirectinteraction with tumor cells.
•MSCs may be involved in many aspects of regulating immune surveillance, apoptosis, and angiogenesis during tumor development as a source of soluble factors.
•hMSCs home to sites of tumorigenesis, where they inhibit tumor cell function.
•The potential role of MSCs in cell-based anti-cancer therapy: (1) as a vehicle for therapeutic drug and (2) as a vehicle for prodrug gene therapy.
Was "acute phenomena" something BJ said.
The reason I ask is because MSCs and likely MAPCs show promise for septicemia.
Sepsis and septic shock therapies are a $1 billion market.
I could see an Athersys takeout for this alone.
Try reading people!
WR = wedge resection
WRB = WR plus brachytherapy
SBRT = stereotactic body radiation therapy
Local control (LC) was SIMILAR in the three groups (p = 0.60) (p value needs to be lower):
92.2% for WR
96.2% for WR+Cs-131
95.5% for SBRT .
Five-year overall survival was similar to WR (p = 0.02):
100% in the WR+B group
97.7% in the WR group
89.6% in the SBRT group
Was similar in the three groups.
Analysis of stereotactic radiation vs. wedge resection vs. wedge resection plus Cesium-131 brachytherapy in early-stage lung cancer. Bhupesh Parashar et al., 2015. (Brachyjournal)
Agreed, I think Chugai feels they paid $10 million and now have the upper hand.
They are going to hold Gil's feet to the fire. But, in the end, are they going to give Multistem a second chance in some way?
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.