Theriva Biologics Inc (TOVX)

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here it is...............

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A Phase I/II Trial of Tetrathiomolybdate for Patients With Idiopathic Pulmonary Fibrosis Refractory to Previous Therapy, [Publication Page: A497]

K.R. Flaherty, M.D., M.S., G.J. Brewer, M.D., A. Andrei, PhD., S. Murray, ScD., G.B. Toews, M.D., F.J. Martinez, M.D., M., Ann Arbor, MI

Rationale: IPF is a fatal disorder without effective therapy. Tetrathiomolybdate (TM) is an anti-Copper drug developed for the treatment of Wilsons disease. TM is effective in modulating the fibrotic response in a Bleomycin mouse model of pulmonary fibrosis.
Methods: We treated 23 patients with IPF that had evidence of disease progression despite treatment with prednisone +/- cytotoxic therapy with TM for 1 year. Patients were monitored for adverse events, change in pulmonary function and walk distance. When pre-treatment FVC values were available the course of pre-treatment FVC (slope) was compared to the post-treatment FVC at 6 and 12 months.
Results: The initial three patients developed severe nausea and withdrew from the study prior to reaching a therapeutic copper level. In response, the induction dose was modified and TM was well tolerated in the remaining 20 patients. Dose-related nausea and cytopenias were the most common and expected adverse reactions. Three patients did not complete the trial (patient preference n=2, anemia n=1), 2 patients died during the trial. There was no significant change in FVC % predicted between baseline and 12 months (61 + 13 vs 59 + 13, p=0.18, paired t-test). Average walk distance declined from baseline to 12 months of follow up (871 + 358 vs 646 + 444 feet, p = 0.02, paired t-test).
Conclusion: Treatment with TM for patients with IPF was well-tolerated and associated with a trend toward stabilization in FVC. Further exploration of the therapeutic efficacy of TM through a placebo controlled trial is warranted.