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RegMed Daily, Mid-Day, 10/3/11, investors are getting conflicting messages

The 6 W’s: Who, what, where, when, why and what of it …


Investors are getting confused …. Stocks continue falling, unable to hold on gains in choppy trading < up , down, round and round> after a report showing slightly stronger US manufacturing activity, on worries that Greece would … fail to get its next round of bailout aid on time (when will this end…).

 Mid-Day: The NASDAQ is DOWN -42.29 (-1.75%) to 2,373.11. The Dow is also DOWN -129.04 (-1.18%) to 10.784.34.

 Mid-Day Movers: NeoStem (AMEX: NBS), Opexa (OPXA) and Tengion (TNGN)


What’s new in the regenerative medicine/stem cell market …

Aastrom (ASTM) granted EU Key Composition-of-Matter Patent: ASTM has been granted a key composition of matter patent for Ixmyelocel-T from the EU Patent Office. The patent provides protection throughout the EU for ixmyelocel-T, its investigational product currently in clinical development for the treatment of critical limb ischemia (NYSE:CLI) and dilated cardiomyopathy (DCM). The issued patent, Mixed Cell Populations for Tissue Repair and Separation Technique for Cell Processing, provides protection for various claims regarding “an isolated cell composition comprises a mixed population of cells of hematopoietic, mesenchymal and endothelial lineage,” which characterizes the ixmyelocel-T product. The bottom line, the patented single-pass perfusion technology enables the production of ixmyelocel-T through selective expansion of specific cell populations which have been shown in preclinical and clinical studies to reduce inflammation (which is associated with atherosclerotic vascular disease), remodel ischemic tissue, and promote the formation of new blood vessels.

NeoStem’s (AMEX: NBS) Progenitor Cell Therapy announce a Manufacturing Agreement: ImmunoCellular Therapeutics (OTC BB: IMUC) has added Progenitor Cell Therapy (PCT) as a 2nd manufacturing site to produce ICT-107 for P2 trial, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma.  As part of this agreement, PCT will transfer and qualify the cGMP manufacturing process for ICT-107 at PCT’s West Coast facility inMountain View, Ca for use in IMUC’sUS based P2 clinical trial, as well as subsequent manufacturing to support future trials and development efforts. The bottom line, NBS …Revenue …This agreement with PCT represents a major risk mitigation step in conducting IMUC’s P2 study of ICT-107 by having 2 manufacturing sites. “PCT has significant experience in developing and manufacturing patient-specific products and capabilities for supporting this manufacturing into P3 and commercialization. PCT’s competencies are in autologous cell therapies, cell manufacturing, cell processing and delivery.

TiGenix (NYSE Euronext: TIG) Financing facility for P3 fistula program in Crohn’s disease: TIG’s wholly-owned subsidiary Cellerix SA is to receive a EUR 4.95M soft loan from the “Madrid Network” to finance the P3 study for complex perianal fistulas in Crohn’s disease patients. The EUR 4.95M loan will be made available in 3 tranches, of which the 1st 40% upon signing of the agreement. The loan will be repayable in 20 tranches over a period of 10 years starting 6/15 with at a very favorable annual interest rate. The bottom line, Cellerix’ lead product Cx601 is based on expanded adipose tissue-derived mesenchymal stem cell (eASC) platform.  Cellerix claims ASCS can inhibit immune cell activation, proliferation and function through the selective induction of regulatory T cells. The firm is thus developing an immunotherapy platform to enable the large-scale production of regulatory T cells in the presence of ASCs. Lead program, Cx911, is in preclinical development. The cells suspension is in development for local administration to treat complex anal fistulas in patients with Crohn disease. Madrid-based Cellerix claims the treatment acts by controlling inflammation to promote natural closure of the lesion. A P3study is projected to start in 2012. This financing will cover a significant part of the development costs of Cx601 and allows financing the P3 independently to retain much more of its value in potential partnering agreements. TiGenix and Cellerix announced their share-based merger in February, in a deal that valued the Spanish firm at some €58M.