Delving into the Latest Updates on Genyous Biomed International, Inc. with Synapse

Overview

Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate cancer who are otherwise healthy and free of significant co-morbidities and have chosen active surveillance for disease management. The investigators will assess how OMN54 affects PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will be tested to follow disease evolution.

Start Date01 Jan 2025

Sponsor / Collaborator

Omnitura Therapeutics, Inc.

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NCT01555242 / CompletedPhase 1

A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Aneustat™ (OMN54) Administered on a Daily Oral Regimen in Patients With Advanced Cancer and Lymphomas

This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.

Start Date01 Aug 2012

Sponsor / Collaborator

Omnitura Therapeutics, Inc.

100 Clinical Results associated with Genyous Biomed International, Inc.

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0 Patents (Medical) associated with Genyous Biomed International, Inc.

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Literatures (Medical) associated with Genyous Biomed International, Inc.

06 Nov 2020·Clinical Cancer Drugs

A Phase I Study of OMN54 (Aneustat™) in Patients with Advanced Malignancies

Author: Sutcliffe, Simon ; Tinker, Anna V. ; Mitchell, Teresa ; Lam, Stephen ; Ostrem, John ; Kwok, David ; Chia, Stephen ; Gelmon, Karen A. ; Renouf, Daniel J. ; Kollmannsberger, Christian ; Joshi, Teresa

Background/Objective:With the increasing interest in natural products, a phase I openlabel study of OMN54 (Aneustat™) in patients with advanced malignancies was initiated to determine toxicity, maximum tolerated dose (MTD), dose limiting toxicities (DLT), and pharmacokinetics (PK). OMN54 is a multitargeted agent, combining three Chinese botanicals; Ganoderma lucidium, Salvia miltiorrhiza and Scutellaria barbata.Methods:Eligible patients (pts) were >18 years of age with advanced solid tumors, able to swallow oral capsules, ECOG performance status < 2, measurable disease as defined by RECIST 1.1 and adequate organ function.Results:Twenty-two patients were enrolled in 6 dose levels, 2 with daily dosing and 4 with twicedaily dosing ranging from 1 to 5 grams daily. All were evaluated for toxicity and 20 for response. No treatment-related dose-limiting toxicities (DLTs) were reported and the recommended phase II dose (RP2D) was determined to be 2.5 g twice daily. Seven adverse events in 5 patients were reported as possibly drug-related; 6 were GI toxicity and 1 was a skin disorder. All were grade 1 except one grade 2 vomiting. No RECIST responses were seen. Six pts were treated with > 2 cycles; one for 8 cycles. Four patients had reductions in TGF –β and EGF, exploratory biomarkers possibly suggestive of a drug effect. Plasma half-lives of 1 -2 hours were noted for all parent drug chemical markers with no accumulation over time.Conclusion:OMN54 was well tolerated, with no DLTs observed. Further studies at the RP2D will assess the biological activity.

100 Deals associated with Genyous Biomed International, Inc.

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100 Translational Medicine associated with Genyous Biomed International, Inc.

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Pipeline

Pipeline Snapshot as of 15 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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Current Projects

Drug(Targets)	Indications	Global Highest Phase

VTT-201 ( KLK3 )	Prostatic Cancer More	Discontinued
OMN-54 ( Adenosine receptor x COX-2 x PXR )	Advanced cancer More	Pending
VTT-301	Prostatic Hyperplasia More	Pending