Mesoblast Intervertebral Disc Repair Phase II Trial Update ($MSB)

Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) is the world’s leading developer of innovative biological products for the broad field of regenerative medicine.  Mesoblast’s commercial strategy is based on its unique proprietary adult mesenchymal precursor cells.  The company’s lead products will target cardiovascular conditions, diabetes, inflammatory conditions of lungs and joints, eye diseases, bone marrow cancers, bone fractures, cartilage degeneration and musculoskeletal conditions. Mesoblast and Teva Pharmaceutical Industries Ltd. have established a strategic alliance to commercialize adult stem cell products for degenerative conditions of the cardiovascular and central nervous systems. The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.

Mesoblast announced that its Phase 2 clinical trial of allogeneic (off-the-shelf) Mesenchymal Precursor Cells has now enrolled 50% of the total study patients.  This trial will investigate non-surgical treatment of lower back pain due to degenerated intervertebral discs.  The rapid enrollment of this study indicated the Phase 2 trail will reach full capcity for its study by the third quarter.  The pace in which this study has enrolled participants bespeaks of the great need back patients have for non-surgical treatments.   

The Company commented,

"Up to 15 per cent of people in industrialized countries have chronic low back pain lasting more than six months. For those with progressive, severe and debilitating pain due to degenerating intervertebral discs, the only current option is major back surgery involving spinal fusion, artificial disc replacement, or other surgical procedures. Avoidance of surgery and its complications is a major objective of any new treatment for degenerative disease of the spine."

Mesoblast published the results of its previous successful study in the March 2012 issue of the Journal of Neurosurgery. 

Read the full press release here.  

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.

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Alliance for Regenerative Medicine, January 10, 2012, San Francisco

The Alliance for Regenerative Medicine Announces Presenting Companies and Second Annual State of the Industry Briefing and Regenerative Medicine Insight Track at Biotech Showcase

Event Takes Place on January 10, 2012 in San Francisco; Expanded Agenda Includes Panel Sessions on Major Regenerative Medicine Target Indications

PRESENTING COMPANIES: Aastrom Biosciences, Advanced BioHealing, Advanced Cell Technology, Aldagen, Allocure, Amorcyte, Athersys, Axogen, Coronado Biosciences, Cytori Therapeutics, Dendreon, Harvard Biosciences, Healthpoint, ImmunoCellular Therapeutics, InVivo Therapeutics, ISTO Technologies, Maxcyte, Mesoblast, MolMed, Neostem, Neuralstem, NexImmune, Organovo, Prima Biomed, Q Therapeutics, ReNeuron, SanBio, StemCells, Inc., Tengion, TiGenix, Tissue Genesis

The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, today announced that the second annual State of the Industry Briefing will take place on January 10, 2012 in San Francisco. A full day of panels focused on several disease areas will follow the briefing as part of the Regenerative Medicine Insight track at the Biotech Showcase 2012. The panels will be moderated by key analysts in the sector.

The Regenerative Medicine State of the Industry Briefing will focus on recent developments and the future outlook for the cell therapy and regenerative medicine industries. Speakers will include Gil Van Bokkelen, CEO of Athersys; Silviu Itescu, CEO of Mesoblast; Tim Mayleben, CEO of Aaastrom; Gary Rabin, CEO of Advanced Cell Therapy; Dr. Robin Smith, CEO of NeoStem and senior executives from large pharmaceutical companies. The panels will cover the outlook for the industry, a review of pipelines and clinical trials, and a general discussion of critical success factors including technology advancements, regulatory issues and the financial outlook for the sector.

A series of analyst-led, therapeutic area focused panels will follow the briefing. The panels will discuss therapeutic categories where regenerative medicine holds great promise including cardiology and ischemic related disease, spinal injury, ophthalmology, metabolic disease, and central nervous system disorders as well as an exploration in cell based solutions in immunology and oncology. The panels will be moderated by analysts from Rodman & Renshaw, Piper Jaffray, JMP Securities, ROTH Capital Partners, and WBB Securities and feature participation from more than 25 companies including:

Aastrom, Advanced BioHealing/Shire, Advanced Cell Technology, Aldagen, Athersys, Cytori, Healthpoint, ISTO Technologies, Maxcyte, Mesoblast, Neostem, Organovo, ReNeuron, SanBio, StemCells, Inc., Tengion and Tigenix.

"We are excited to once again bring together many of the leading experts in the regenerative medicine field to report on the progress made during 2011 and provide an outlook for 2012 and beyond," said Gil Van Bokkelen, PhD, Chairman of ARM and CEO of Athersys. "Based on the significant response to the meeting last year, it's clear that recognition of the near-term therapeutic promise of regenerative medicine is growing, and this event represents a great opportunity for investors and others to hear from industry leaders and gain insight into the tremendous potential of the field."

This event was developed by the Alliance for Regenerative Medicine, and will be held as part of the Biotech Showcase 2012 conference taking place at the Park 55 Wyndham in San Francisco beginning at 8:00 a.m. To learn more and to register for the conference, please contact Rob Margolin at (646) 201-4192. Registration is complimentary for credentialed members of the media and the investment community. The State of the Industry briefing is open to the public, but attendance at the disease panels will require registration for individuals without press or investor credentials.

The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit www.alliancerm.org .

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