A Double Blind, Ascending Multiple Dose Study to Evaluate the Safety and Tolerability of GAL-021 in Healthy Volunteers. - An Ascending Multiple Dose Study of GAL-021.

Start Date01 Oct 2013

Sponsor / Collaborator

Galleon Pharmaceuticals, Inc.

NL-OMON37240 / CompletedNot Applicable

A Two-Part, Double Blinded, Placebo Controlled, Crossover Repeated Stepped Infusion Dose Study of Respiratory Pharmacodynamics of GAL- 021 and Opioids (Protocol - GAL-021-104). - A two-part study of the effects of GAL-021 and opioids.

Start Date29 Oct 2012

Sponsor / Collaborator

Galleon Pharmaceuticals, Inc.

NL-OMON37672 / CompletedNot Applicable

A Single Dose Study of the Pharmacodynamics, Tolerability, and Pharmacokinetics of GAL-054 - Single Dose PD and Tolerability of GAL-054

Start Date17 Oct 2011

Sponsor / Collaborator

Galleon Pharmaceuticals, Inc.

100 Clinical Results associated with Galleon Pharmaceuticals, Inc.

0 Patents (Medical) associated with Galleon Pharmaceuticals, Inc.

Literatures (Medical) associated with Galleon Pharmaceuticals, Inc.

01 Feb 2024·Biomedicine & Pharmacotherapy

L-cysteine ethylester reverses the adverse effects of morphine on breathing and arterial blood-gas chemistry while minimally affecting antinociception in unanesthetized rats

Article

Author: Coffee, Gregory A ; Wilson, Christopher G ; May, Walter J ; Lewis, Stephen J ; Baby, Santhosh M ; Getsy, Paulina M ; Young, Alex P ; Hsieh, Yee-Hee ; Bates, James N ; Lewis, Tristan H J

L-cysteine ethylester (L-CYSee) is a membrane-permeable analogue of L-cysteine with a variety of pharmacological effects. The purpose of this study was to determine the effects of L-CYSee on morphine-induced changes in ventilation, arterial-blood gas (ABG) chemistry, Alveolar-arterial (A-a) gradient (i.e., a measure of the index of alveolar gas-exchange), antinociception and sedation in male Sprague Dawley rats. An injection of morphine (10 mg/kg, IV) produced adverse effects on breathing, including sustained decreases in minute ventilation. L-CYSee (500 μmol/kg, IV) given 15 min later immediately reversed the actions of morphine. Another injection of L-CYSee (500 μmol/kg, IV) after 15 min elicited more pronounced excitatory ventilatory responses. L-CYSee (250 or 500 μmol/kg, IV) elicited a rapid and prolonged reversal of the actions of morphine (10 mg/kg, IV) on ABG chemistry (pH, pCO₂, pO₂, sO₂) and A-a gradient. L-serine ethylester (an oxygen atom replaces the sulfur; 500 μmol/kg, IV), was ineffective in all studies. L-CYSee (500 μmol/kg, IV) did not alter morphine (10 mg/kg, IV)-induced sedation, but slightly reduced the overall duration of morphine (5 or 10 mg/kg, IV)-induced analgesia. In summary, L-CYSee rapidly overcame the effects of morphine on breathing and alveolar gas-exchange, while not affecting morphine sedation or early-stage analgesia. The mechanisms by which L-CYSee modulates morphine depression of breathing are unknown, but appear to require thiol-dependent processes.

01 Jan 2023·Frontiers in pharmacology

Hypoxia releases S-nitrosocysteine from carotid body glomus cells-relevance to expression of the hypoxic ventilatory response.

Article

Author: Baby, Santhosh M ; Lewis, Tristan H J ; Bates, James N ; Seckler, James M ; Getsy, Paulina M ; May, Walter J ; Lewis, Stephen J ; Gaston, Benjamin

We have provided indirect pharmacological evidence that hypoxia may trigger release of the S-nitrosothiol, S-nitroso-L-cysteine (L-CSNO), from primary carotid body glomus cells (PGCs) of rats that then activates chemosensory afferents of the carotid sinus nerve to elicit the hypoxic ventilatory response (HVR). The objective of this study was to provide direct evidence, using our capacitive S-nitrosothiol sensor, that L-CSNO is stored and released from PGCs extracted from male Sprague Dawley rat carotid bodies, and thus further pharmacological evidence for the role of S-nitrosothiols in mediating the HVR. Key findings of this study were that 1) lysates of PGCs contained an S-nitrosothiol with physico-chemical properties similar to L-CSNO rather than S-nitroso-L-glutathione (L-GSNO), 2) exposure of PGCs to a hypoxic challenge caused a significant increase in S-nitrosothiol concentrations in the perfusate to levels approaching 100 fM via mechanisms that required extracellular Ca²⁺, 3) the dose-dependent increases in minute ventilation elicited by arterial injections of L-CSNO and L-GSNO were likely due to activation of small diameter unmyelinated C-fiber carotid body chemoafferents, 4) L-CSNO, but not L-GSNO, responses were markedly reduced in rats receiving continuous infusion (10 μmol/kg/min, IV) of both S-methyl-L-cysteine (L-SMC) and S-ethyl-L-cysteine (L-SEC), 5) ventilatory responses to hypoxic gas challenge (10% O₂, 90% N₂) were also due to the activation of small diameter unmyelinated C-fiber carotid body chemoafferents, and 6) the HVR was markedly diminished in rats receiving L-SMC plus L-SEC. This data provides evidence that rat PGCs synthesize an S-nitrosothiol with similar properties to L-CSNO that is released in an extracellular Ca²⁺-dependent manner by hypoxia.

01 Dec 2022·Biomedicine & Pharmacotherapy

The ventilatory depressant actions but not the antinociceptive effects of morphine are blunted in rats receiving intravenous infusion of L-cysteine ethyl ester

Article

Author: May, Walter J ; Lewis, Stephen J ; Getsy, Paulina M ; Baby, Santhosh M ; Young, Alex P ; Bates, James N ; Ryan, Rita M ; Seckler, James M ; Hsieh, Yee-Hsee ; Lewis, Tristan H J

This study demonstrates that intravenous infusion of the cell-penetrant thiol ester, L-cysteine ethyl ester (L-CYSee), to adult male Sprague-Dawley rats elicited (a) minor alterations in frequency of breathing, expiratory time, tidal volume, minute ventilation, or expiratory drive but pronounced changes in inspiratory time, end-inspiratory and expiratory pauses, peak inspiratory and expiratory flows, EF₅₀, relaxation time, apneic pause, inspiratory drive and non-eupneic breathing index, (b) minimal changes in arterial blood-gas (ABG) chemistry (pH, pCO₂, pO₂, SO₂) and Alveolar-arterial (A-a) gradient (index of alveolar gas exchange), and (c) minimal changes in antinociception (tail-flick latency). Subsequent injection of morphine (10 mg/kg, IV) elicited markedly smaller effects on the above parameters, ABG chemistry, and A-a gradient in rats receiving L-CYSee, whereas morphine antinociception was not impaired. Infusions of L-cysteine or L-serine ethyl ester (oxygen rather than sulfur moiety), did not affect morphine actions on ABG chemistry or A-a gradient. L-CYSee (250 μmol/kg, IV) injection elicited dramatic changes in ventilatory parameters given 15 min after injection of morphine in rats receiving L-CYSee. Our findings suggest that (a) L-CYSee acts in neurons that drive ventilation, (b) L-CYSee reversal of the adverse actions of morphine on ventilation, ABG chemistry and A-a gradient may be via modulation of intracellular signaling pathways activated by morphine rather than by direct antagonism of opioid receptors since morphine antinociception was not diminished by L-CYSee, and (c) the thiol moiety of L-CYSee is vital to efficacy, (d) intracellular conversion of L-CYSee to an S-nitrosylated form may be part of its mechanism of action.

100 Deals associated with Galleon Pharmaceuticals, Inc.

100 Translational Medicine associated with Galleon Pharmaceuticals, Inc.

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Drug(Targets)	Indications	Global Highest Phase

(+)-Doxapram ( TASK-1 x TASK-3 )	Hypoxia More	Discontinued
GAL-475	Sleep Apnea Syndromes More	Pending
GAL-044 (Galleon)	Pain More	Pending
GAL-021	Respiratory Insufficiency More	Pending
GAL-160	Sleep Apnea Syndromes More	Unknown

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