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Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in pluristem (4)

Tuesday
Apr172012

Pluristem Receives U.S. FDA Clearance for Phase II Clinical Trial in Intermitten Claudication ($PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market. 

Pluristem Theapeutics announced that the FDA has approved the commencement of Phase II clinical trials of PLX-PAD cell product candidate for the treatment of a form of peripheral artery disease, Intermittent Claudication (IC).  This trial will investigate the safety and effectiveness of of PLX-PAD cells versus placebo.  

Zami Aberman, Chairman and CEO of Pluristem, commented,

"We are excited to receive the world's FDA first clearance for an Intermittent Claudication clinical trial using allogeneic cell therapy as a potential preventive treatment for IC. We believe that our approach of repeatable intramuscular injections will potentially enable us to boost the healing process of our patients. In this trial, we will take benefit of our 'off-the-shelf' PLX properties achieved by our three dimensional (3D) proprietary technology platform for efficient, controlled, mass production of cell therapy product candidates, for the treatment of millions of IC patients around the world."

Read the full press release here.  

Wednesday
Feb012012

ThermoGenesis ($KOOL) now in CLI ! (video)

ThermoGenesis Corp (NASDAQ: KOOL) press released an update on their Res-Q clinical evaluations:

ThermoGenesis Provides Update on Res-Q® Clinical Evaluations at Leading Stem Cell Therapy Conference

INITIAL DATA SHOW POSITIVE OUTCOMES IN TREATING CRITICAL LIMB ISCHEMIA AND LONG BONE FRACTURES

What is Res-Q ?  This is a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP). The product is being tested in India in a trial co-sponsored by ThermoGenesis and Totipotent SC, the company's distributor for the Res-Q in India.

The trial has evaluated n=10 of n=15 planned patients with advanced CLI. Safety and AFS (limb salvage) at one year are being evaluated. Secondary endpoints such as ABI (ankle brachial index), six minute walk test, and resting pain are showing good results.

In addition a second trial is evaluating n=16 of n=20 patients with non-union or delayed union fracture of a long bone (tibia) who have undergone composite grafting with autologous bone marrow cell concentrate to evaluate the procedure's safety and effect on fracture healing. Long bone fractures represent an unmet medical need that the med tech companies have been chasing for years. So far the system has shown no intra-operative complications, and one non-device related adverse event. Of nine patients who are now out three-to-six months post-treatment, four have fractures that have united and four have experienced partial unions of the bone fracture which is quite hopeful.

Daily Dose Conclusion: Few are paying attention to KOOL as a therapeutic player in CLI or bone fractures and as a potential challenger to Cytori or even Aastrom or Pluristem in CLI. This is worth watching.

Tuesday
Jan312012

MesoBlast ($MSB): FDA Green Lights PII Trial for Type 2 Diabetes

MesoBlast (ASX: MSB) press released FDA approval to move to a PII trial today. Recall that MSB's product is "allogeneic" (other people's cells) and as such is "off-the-shelf" ready. Similar to Athersys and PluriStem approaches. Diabetes is a large market and is often related to an auto-immune condition that results in damage to the insulin producing cells (islets of the pancreas).

The MesoBlast trial will be a randomized, placebo-controlled, 3 month trial that will evaluate a single IV injection of one of three (progressively higher doses of cells) in N=60 (Type II diabetes patients) who show elevated blood glucose levels. Animal data in this indication showed hints of activity. MesoBlast has demonstrated safety with their product in several prior trials.

Daily Dose Conclusion: MesoBlast recognizes that their cell therapy product may have multiple uses and multiple indications. MesoBlast had a BIG WIN when Cephalon invested in their therapy (since acquired by Teva). With that said the market cap of MesoBlast peaked back in November and has come down sharply (>40%) as investors have struggled with the high valuation. The cardiology data presented at AHA seemed to mark the peak. Valuations for Mesoblast versus other Allogeneic companies in the space such as Athersys and PluriStem are tough to understand.

Monday
Dec192011

Geron versus PluriStem @ Seeking Alpha? That's the wrong question......

We saw an article at Seeking Alpha talking about Pluristem versus Geron. The PluriStem CEO does a compare and contrast. While PSTI CEO Zami makes some good points regarding market size, were not sure that any comparison to Geron makes any sense.

Allogeneic cells (other peoples cells) do fit the pills in a bottle model that Pharma craves but as we have heard Zami himself say at multiple conferences, these allogeneic cells (even though they are from a placenta) do not integrate long term to the host. Therefore the effect is likely moderate, and that may be fine depending on the indication.

CLI (Critical Limb Ischemia) itself is a very variable disease and PluriStem has Phase 1 data and is just beginning their Phase 2 trial. So its early days for sure. Aastrom is also pursuing CLI and now is in a Phase 3 trial. As we have said in the past we are hopeful that the results will be good for both companies but neither company has definitive data sets yet and the disease itself is very variable. As such investors can't be sure what the outcome of these trials might be. In the case of Aastrom the P2 first interim analysis looked great but the second did not (the amputation rate in the placebo group improved and narrowed the difference between active and control). CLI is a variable disease and this happens. Aastrom is smart, they expanded the P3 trial (made it larger), which gives them a greater chance of success but it also means it will be more expensive and probably take longer to complete.

We would push the concepts here back to basics and get away from a comparison between an off the shelf allogeneic cell that is targeting angiogenesis (new blood vessel formation), improving circulation versus an embryonic approach that it was hoped could repair damaged signal conduits (nerves), paralysis.

Rather we ask how did CLI patients become ill in the first place? Poor circulation, diabetes, and other co-morbidities are likely part of the problem. So while fixing circulation, locally, may stave off an amputation, it seems like it is not addressing the underlying cause. Why inject intra-muscular versus intra-arterial? Basic science questions such as dose, biological mechanism of action, clinical effect, even product variability remain issues with many of the institutional investors who are following these cell therapy companies.

We note that Biotech giant is Celgene (CELG) is also working on placental based cell therapy but here it is for down-regulation inflammation, in Crohns Disease for patients who have failed steroids. We also know that Athersys and Pfizer are pursuing this approach also with an allogeneic therapy (MultiStem). Proof of Concept from a Celgene or a Pfizer would be a big deal for all in the space.

We certainly believe that there is a role for allogeneic therapy as well as autologous and that indications should dictate, which therapy is best for which indication. The lower cost of goods and the multiple treatments likely for CLI do favor allogeneic players where the opposite is true in cardiovascular disease (heart attacks, CHF and cardiac ischemia). For example news today that Cytori has filed its Investigational Device Exemption (IDE) application to begin a clinical trial of the Celution® System for chronic myocardial ischemia (CMI). Cytori's ATHENA represents a device-based (Phase I/II) to investigate the use of autologous, clinical-grade adipose tissue (fat) derived stem and regenerative cells (ADRCs). This all happens at the patients point-of-care with Cytori’s Celution® System.

The institutional community evidenced by stock prices is not excited about CLI (long and expensive trials, variable disease), but granted, very much an unmet medical need. So while Geron's departure in the space is (was) a disappointment the clinical advances of other companies like MesoBlast, Athersys, Cytori, Aastrom, NeoStem, and yes PluriStem are positive.

In fact we are excited to see what happens with the work that PluriStem is doing with United Therapeutics in the COPD (airways) space.