The 6 W’s: The … who, what, where, when, why and what of it.
Regenerative medicine/stem cell universe stocks are down since the day started on Thursday (5/5/11). The NASDAQ is up +14.09 (0.50%) to 2842.32 (yesterday: 2828.23). The Dow is down -38.42(-0.27%) to 12,688.75 (yesterday: 12,723.58). On Wednesday, depreciation ruled the day … After a flat 2 weeks with NO new highs, a continued pullback in the regenerative medicine/stem cell continues. The intermediate-term trend is still flat as earnings become available but the CIRM’s funding to GERN sets a visibility factor. But, at the same time, the structure of 2011 trading is a bit more problematic.
ImmunoCellular Therapeutics (OTCPK:IMUC) Survival Data from PI Study in Glioblastoma OTCBB: IMUC.OB announced updated long-term data from a Phase I clinical trial of ICT-107, the lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received 3 injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. IMUC.OB has reported 2 year median survival rate of 80.2% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with standard of care alone. The study’s median progression free (PFS) survival of 16.9 months compared especially favorably to the historic median PFS of 6.9 months. 10 of the 16 patients continue to survive. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis. The bottom line, the data show 6 out of 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence, with 3 of these patients (18.8%) remaining disease –free for almost 4 years while the other 3 patients have gone more than 2 1/2 years disease-free. No new patients have shown disease recurrence since the last report of data in 9/10. No treatment-related serious adverse events have been observed to date. The additional long-term data demonstrate that ICT-107 provides clinical benefit far beyond the standard of care to patients with glioblastoma multiforme, and support the Phase II trial of ICT-107. This data supports the outcomes previously reported in our Phase I study. IMUC.OB is trading up $0.01($0.51%) to $1.98 mid-day.
StemCells (STEM) axes 20 staffers as it conserves cash for trial work STEM faced with steep costs for the clinical development of its neural stem cell treatment for spinal cord injuries, trimmed 20 workers from its staff, eliminating 1/3 of its workforce in a cost-cutting effort aimed at slowing its burn rate. The layoffs mark the latest in several moves aimed at slowing the burn. The bottom line, StemCells lead program is in a Phase I/II clinical trial being conducted in Switzerland. With multiple clinical trials underway and others soon to begin, STEM should be generating clinical data regarding the therapeutic potential of HuCNS-SC cells as these trials run their course. STEM had reported that it had gathered positive animal data on its neural stem cell treatment for lost motor function. STEM is trading down $0.007 (-0.87%) to $0.807 in mid-day trading.
Geron Announces $25M in Funding from CIRM As reported last night, GERN has been approved to receive a Targeted Clinical Development Award totaling $25M from the California Institute for Regenerative Medicine (CIRM). The funding will support the clinical development of GRNOPC1, GERN’s cell (hESC) therapy containing oligodendrocyte progenitor cells derived from human embryonic stem cells (hESCs), currently in a P1 trial in patients with spinal cord injury. The bottom line, GERN’s application was approved for funding to conduct a P1 clinical trial of GRNOPC1 in patients with neurologically complete injuries in the thoracic region of the spinal cord. In this first cohort of patients, a dose of 2M cells is being administered to assess safety. Pending demonstration of safety, clinical testing will be expanded to patients with injuries to the cervical region and to patients with incomplete injuries, as well as to assess escalating doses of GRNOPC1. The Award will be structured as a product-backed loan, such that GERN’s obligation for repayment will be contingent on commercial success of GRNOPC1 for spinal cord injury. GERN is trading up $0.06 ((1.24%) in mid-day trading.