Delving into the Latest Updates on Immune Control, Inc. with Synapse

Overview

We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.

Start Date01 Jul 2006

Sponsor / Collaborator

Tufts Medical Center, Inc.

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100 Clinical Results associated with Immune Control, Inc.

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0 Patents (Medical) associated with Immune Control, Inc.

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Literatures (Medical) associated with Immune Control, Inc.

16 Nov 2008·Blood

A Phase 1 Trial of Fluphenazine HCl (Fz), a Serotonin Antagonist, in Relapsed and Refractory Multiple Myeloma

Author: Silver, Bruce ; DeYoung, Linda ; Narayanan, Geetha ; Prasad, Sripada V.S.S ; Jain, Minish ; Lane, Alice ; Stinnett, James ; Bapsy, P.P. ; Ganesan, Trivadi ; Stadtmauer, Edward A. ; Siegel, David ; McNair, Douglas S ; Vogl, Dan T

AbstractBackground: Serotonin (5-HT) is a lymphocyte growth factor, and lymphocytes bear 5-HT receptors. Fz has anti-serotonergic properties and a favorable safety profile. Fz inhibits growth of Jurkat leukemia cells at concentrations of 1–10 μM (Schleuning M et al, Anticancer Research 1993;13:599–602). Other serotonin receptor antagonists have been shown to have in vitro and pre-clinical in vivo anti-myeloma effects mainly mediated by apoptosis (Ocio EM, et al, Blood 2006 108:Abs 2597). In vitro studies show 10μM Fz exposure for 18hr kills many myeloma and leukemic cell lines, while sparing non-activated, normal, human lymphocytes. In rat studies, Fz partitions into bone marrow (BM) 100× more avidly than into blood. Fz was thus selected for a proof of concept phase 1 trial in patients (pts) with previously treated myeloma.Methods: Pts with myeloma had failed at least 2 prior regimens; had measurable serum or urine M-proteins, or skewed free light chain ratio per central lab assay; had adequate organ function and performance status (ECOG <3); and were not on selective serotoin reuptake inhibitors (SSRIs), tricyclic, or norepinephrine reuptake inhibitor drugs or other anti-serotonergic agents. Fz was given i.v. in a dose escalating “3+3 design” in three divided 5-minute injections at 0, 6, and 12 hrs once every 28 days. Total Fz doses per 3-bolus exposure were 0.11, 0.23, 0.34, 0.57, 0.80, and 1.14 mg/kg. Serum samples for Fz PK analysis were collected from all patients during cycle 1. A single (time-paired with a serum PK sample) BM biopsy for BM Fz level was obtained from a subset of pts.Results: 21 pts (13M; 8F) from 7 sites in the U.S. and India, median age 55 yrs (range 30–75) were enrolled, 3 pts were enrolled per dose cohort, except for 6 pts at 0.34 mg/kg. Median number prior regimens was 4; 15/21 had prior thalidomide or lenalidomide or both; 10/21 had prior bortezomib; 8/21 had prior stem cell transplant (including 2 with tandem transplant, 1 had a third salvage transplant). A MTD was not reached. One DLT, grade 3 extra-pyramidal reaction (EPR) of acute dystonia with stiff jaw, occurred at 0.34 mg/kg. Six pts experienced EPR (4M; 2F) typically occurring 30–36 hrs post first dose; intensity and frequency were not dose related. All EPR except the 1 DLT were grade 1 or 2. Fifteen serious adverse events (SAEs) occurred in 10 pts, all assessed as unrelated to Fz. The most common ≥ gr 3 non-serious AEs were anemia, thrombocytopenia, and back pain, none of which was assessed as related to Fz. All cases of orthostatic hypotension, agitation, EPR, sedation, somnolence, and 3 of 4 cases of fatigue were deemed related to Fz. Comparison of time-paired BM and serum Fz concentrations in 6 pts showed 4–77-fold higher Fz levels in the marrow over serum in the first 49 hrs post-dosing. The best response through 2 cycles of treatment per Blade criteria in 19 evaluable pts was stable disease in 3 pts (0.23, 0.34, and 0.80 mg/kg; duration 2, 5, and 6 cycles).Conclusion: Fluphenazine may be safely given to pts with relapsed and refractory myeloma at the doses and schedule described, with EPR and sedation that are generally mild and manageable. Fz partitions 1–2 log greater into human BM compared with serum. A MTD was not reached, and additional studies are planned with more dose-intensive schedules.

100 Deals associated with Immune Control, Inc.

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100 Translational Medicine associated with Immune Control, Inc.

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Pipeline

Pipeline Snapshot as of 27 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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