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Henry McCusker
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Analyst, Journalist and Publisher ... Henry enters his tenth (10) year at Scimitar Equity -Regenerative Medicine Investors which aggregates, curates and creates bottom-line content weeding of regenerative medicine and cell therapy news to provide a customized, vetted selection of relevant and... More
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  • Tengion (OTC QB: TNGN) Clinical Progress And Regulatory Advance 0 comments
    Feb 1, 2013 9:11 AM

    Advances for its 2 lead programs, the Neo-Urinary Conduit™ and Neo-Kidney Augment™

    TNGN's 7th Patient Implanted in Neo-Urinary Conduit P1 Clinical Trial; On Track to Complete Enrollment by End of Q1/13 + Application to Conduct Neo-Kidney Augment P1 Trial Filed with Swedish Medical Products Agency -

    Neo-Urinary Conduit P1 Clinical Trial has successfully implanted the 7th patient in the ongoing P1 clinical trial of its most advanced product candidate, the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients. The Neo-Urinary Conduit offers patients potential improvements over the standard of care, including a shorter and less complex surgical procedure, improved recovery times and faster hospital discharges, as well as no evidence of the typical post-operative co-morbidities associated with the current standard of care.

    Neo-Kidney Augment Clinical has filed a Clinical Trial Application (CTA) with the Medical Products Agency (NYSE:MPA) in Sweden to initiate a P1 clinical trial to evaluate safety and delivery of its Neo-Kidney Augment product in up to five patients with chronic kidney disease (CKD). The Neo-Kidney Augment is intended to prevent or delay the need for dialysis or kidney transplant by catalyzing the regeneration of functional kidney tissue in patients with advanced CKD. Following MPA approval of the CTA, Tengion expects to initiate a P 1 trial in Sweden in Q2/13.

    The Bottom Line; TNGN is proceeding with concurrent enrollment of the remaining 3 patients in the P1 trial. There are now 6 centers open for recruiting patients for this clinical trial and Tengion anticipates that it will implant. 10 patients by the end of Q1/13 would complete enrollment in the trial.TNGN also expects to submit an IND filing for the Neo-Kidney Augment to the FDA during Q2/13. Following FDA approval of the IND, Tengion expects to initiate a P1 clinical trial in Q4/13 and anticipates that this trial will provide initial human proof-of-concept data in 2014.

    TNGN closed at $1.35 down <from $1.40 on 1/29/13> with 16.7 K volume on 1/31/13 and has been slipping up and down since 1/2/13. I project <accepting the craziness of this market> at least a 1-3% pop in the stock <but, it is Friday>!

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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