The RegMed Daily Dialogue, Monday, 5/16/11, Navigating the soft patch
Regenerative medicine/stem cell universe stocks are down in late trading on Monday (5/16/11). The NASDAQ is down -28.65 (-1.01%) to 2799.82. The Dow is also down 0.23 (0.00%) to 12,595.52. What’s driving the regenerative medicine – stem cell market today … not much!
US equities are trading lower as a mid-morning recovery fades and the markets continue to focus on heightened Eurozone uncertainties following the arrest of IMF’s Strauss Kahn. Tech and discretionary are leading declines. Financials and materials are leading gains.
ACTC.OB, AMEX: NBS, AMEX: CUR, ASTM, IMUC.OB are up!
Advanced Cell Technology (ACTC.OB) Institutional Review Board (IRB) approves P1/2 Trial using hESC-Derived RPE Cells for Stargardt’s Macular Dystrophy (SMD): The Casey Eye Institute (CEI) at Oregon Health & Science University (OHSU) in Portland, Ore., has received institutional review board (IRB) approval to be a site for its P1/2 human clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The bottom line, the P1/2 trial will be prospective, open-label study designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD.
Stryker to buy Orthovita for $304M: Stryker Corporation will buy all of the common stock of Orthovita, a specialty spine and orthopedic company, for $3.85 per share, representing a total value of roughly $316M, a 41% premium. The deal also includes $12M in debt. Orthovita competes in the $5M orthobiologics market with its Vitoss bone graft substitute. It also competes in the vertebral augmentation market with its Cortoss bone augmentation material. The bottom line, another biologic acquisition by a device maker.
Pluristem’s CEO issued a shareholder letter explaining its comprehensive clinical plan includes a Phase II multinational IC study that will enroll subjects suffering from a less severe form of PAD, a potentially preventive treatment which may have an impact on the disease progression. In addition, PSTI is aiming for a CLI Phase II/III multinational pivotal study with the primary endpoint of major-amputation free survival rate following 12 months of follow-up. In both the CLI and IC studies, PLX-PAD cells will be injected twice, 4 months apart. PSTI’s cells are an allogeneic therapy, require no tissue matching prior to administration, allowing no pre-treatment discomfort and are an “off the self” product. The PII IC study will enroll approximately 180 patients and the PII/III CLI study to enroll approximately 450 patients. Both studies will include a control group. The clinical sites which participated in earlier PI studies will take part in the upcoming studies and currently are in the process of selecting additional sites. PSTI is also focused on scaling up its proprietary three-dimensional (3D) cell manufacturing platform from pilot to a commercial production stage. Its up-scaled bioreactor system is capable of manufacturing millions of PLX doses originating from different placentas. PSTI’s manufacturing process has demonstrated batch to batch consistency, an important manufacturing component of biological products. In addition, scalable manufacturing is one of the major challenges cell based products are facing. The bottom line, the studies will begin once the protocol design is finalized, upon regulatory approval and upon completion of vendor selection to support the study (for example: monitoring, data management and pharmacovigilance). PSTI announced in 4/11 that 6 month clinical follow-up data from its 2 open-label, dose-escalation, PI clinical trials conducted in the US and Germany suggest PLX-PAD is safe, improves quality of life and is potentially effective in treating CLI patients. Among the 27 patients treated with PLX-PAD, only 1 amputation was recorded at the 6 months follow-up representing a 3.7% amputation rate. This represents a 75% reduction in the amputation rate compared to historical data, which varies from 20-40%.
Venture investments up slightly in Q1/11: VCs put nearly $2.5B into 212 valley companies in Q1/11 – 42% of the total venture dollars invested nationwide. That’s an uptick over both Q4/10 and the year-prior period. The bottom line, in terms of dollars invested, the biotechnology sector was in 3rd place, rising 6% from the prior quarter to $784M. The number of deals dropped, falling 17% from Q4/10.
BioMimetic Falls after FDA Posts Last Week’s Panel Summary: BMTI is down as much as 7.34% on volume 2x 3-month daily avg., after FDA posted a summary of the Augment Bone Graft panel meeting that took place on 5/12.
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