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 Apr 2025·Neuropharmacology

Isobutyric tropine ester (Ibutropin) overcomes fentanyl-induced respiratory depression in unanesthetized rats without compromising analgesia

Article

Author: Bates, James N ; May, Walter J ; Massien, Samantha ; Lewis, Stephen J ; McShine, Alannah ; Coffee, Gregory A ; Hsieh, Yee-Hsee ; Young, Alex P ; Lewis, Tristan H J ; Getsy, Paulina M ; Baby, Santhosh M

We are examining the pharmacological profile of tropine and tropine analogues on opioid-induced respiratory depression (OIRD). We report here the effects of Ibutropin (isobutyric tropine ester, tropine isobutyrate) on the changes in ventilatory parameters, Alveolar-arterial (A-a) gradient (index of alveolar gas-exchange), arterial blood-gas (ABG) chemistry (pH, pCO₂, pO₂, sO₂), sedation (righting reflex), and antinociception (tail-flick latency) in freely-moving male Sprague Dawley rats elicited by prior injection of fentanyl. The injection of fentanyl (75 μg/kg, IV) produced (a) substantial decreases in the frequency of breathing, tidal volume, and minute ventilation, and changes in other ventilatory parameters, and (b) increases in A-a gradient (i.e., mismatch in alveolar ventilation-perfusion) that were accompanied by decreases in arterial blood pH, pO₂, and sO₂, and increases in pCO₂, responses consistent with reduced ventilatory drive. An injection of Ibutropin (200 μmol/kg, IV) given 5 min after fentanyl (75 μg/kg, IV) elicited an immediate and sustained reversal of the adverse effects of fentanyl on recorded ventilatory parameters, A-a gradient and ABG chemistry. Additionally, Ibutropin reduced the sedative, but not analgesic action of fentanyl. These findings show that Ibutropin has the profile to be advantageous for development as an agent to reverse OIRD. It has been shown that tropine itself contrarily worsens the deleterious actions of fentanyl. As, such we conclude that the positive actions of Ibutropin arises from its ability as an ester to readily enter cells and to interrupt the events elicited by fentanyl in ventilatory control pathways, but not those driving the analgesic actions of fentanyl.

01 Mar 2025·Neuropharmacology

Functional evidence that S-nitroso-L-cysteine may be a candidate carotid body neurotransmitter

Article

Author: Coffee, Gregory A. ; Lewis, Stephen J. ; Baby, Santhosh M. ; Seckler, James M. ; Coffee, Gregory A ; Palmer, Lisa A. ; Lewis, Stephen J ; Baby, Santhosh M ; Palmer, Lisa A ; Getsy, Paulina M ; Bates, James N ; Bates, James N. ; Getsy, Paulina M. ; Seckler, James M

The primary objective of the present study is to provide further evidence that the endogenous S-nitrosothiol, S-nitroso-L-cysteine (L-CSNO), plays an essential role in signaling the hypoxic ventilatory response (HVR) in rodents. Key findings were that (1) injection of L-CSNO (50 nmol/kg, IV) caused a pronounced increase in frequency of breathing (Freq), tidal volume (TV) and minute ventilation (MV) in naïve C57BL/6 mice, whereas injection of D-CSNO (50 nmol/kg, IV) elicited minimal responses; (2) L-CSNO elicited minor responses in (a) C57BL/6 mice with bilateral carotid sinus nerve transection (CSNX), (b) C57BL/6 mice treated neonatally with capsaicin (CAP) to eliminate small-diameter C-fibers, and (c) C57BL/6 mice receiving continuous infusion of L-CSNO receptor antagonists, S-methyl-L-cysteine and S-ethyl-L-cysteine (L-SMC + L-SEC, both at 5 μmol/kg/min, IV); and (3) injection of S-nitroso-L-glutathione (L-GSNO, 50 nmol/kg, IV) elicited pronounced ventilatory responses that were not inhibited by L-SMC + L-SEC. Subsequent exposure of naïve C57BL/6 mice to a hypoxic gas challenge (HXC; 10% O₂, 90% N₂) elicited pronounced increases in Freq, TV and MV that were subject to roll-off. These HXC responses were markedly reduced in CSNX, CAP, and L-SMC + L-SEC-infused C57BL/6 mice. Subsequent exposure of all C57BL/6 mice (naïve, CSNX, CAP, and L-SMC + L-SEC) to a hypercapnic gas challenge (5% CO₂, 21% O₂, 74% N₂) elicited similar robust increases in Freq, TV and MV. Taken together, these findings provide evidence that an endogenous factor with pharmacodynamic properties similar to those of L-CSNO, rather than L-GSNO, mediates the HVR in male C57BL/6 mice.

01 Feb 2025·The Journal of Pharmacology and Experimental Therapeutics

The ability of Ibutropin to blunt fentanyl-induced respiratory depression is independent of its activation of carotid body chemoafferents

Article

Author: Hsieh, Yee-Hsee ; May, Walter J ; Baby, Santhosh M ; Lewis, Stephen J ; Coffee, Gregory A ; Getsy, Paulina M ; Bates, James N

This study examined the effects of intravenous injection of isobutyric tropine ester (Ibutropin) on ventilation in freely-moving sham-operated (SHAM) male Sprague Dawley rats and those with bilateral carotid sinus nerve transection (CSNX). This study also examined the effects of a subsequent injection of fentanyl on ventilatory parameters in both groups of rats. Ibutropin (200 μmol/kg, i.v.) elicited rapid and pronounced increases in breathing frequency, tidal volume, minute ventilation, peak inspiratory and expiratory flows, and inspiratory and expiratory drives in SHAM rats, but substantially smaller responses in CSNX rats. The subsequent injection of fentanyl (75 μg/kg, i.v.) elicited similar ventilatory responses in Ibutropin-treated SHAM and CSNX rats with markedly different changes in end-inspiratory and end-expiratory pauses, expiratory delay, and apneic pause. Moreover, the fentanyl-induced responses in Ibutropin-treated SHAM and CSNX rats were substantially smaller than in rats that were pre-injected with vehicle (saline) rather than Ibutropin. These novel findings suggest that Ibutropin acts at the carotid body-chemoafferent complex to drive ventilation by mechanisms that may involve the rapid entry of this cell-permeant tropine ester into chemoafferent nerve terminals and/or primary glomus cells. A key finding was that the ability of Ibutropin to blunt the adverse effects of fentanyl on breathing does not require functional carotid body chemoreceptor afferent input to brainstem structures controlling breathing. As such, the ability of Ibutropin to greatly diminish the adverse effects of fentanyl on breathing may involve the actions of Ibutropin within central respiratory control centers and/or peripheral structures other than the carotid bodies. SIGNIFICANCE STATEMENT: This study revealed that the ability of Ibutropin to blunt the respiratory depressant effects of fentanyl may involve mechanisms present in central respiratory control centers and/or peripheral structures other than the carotid bodies.

News (Medical) associated with Galleon Pharmaceuticals, Inc.

04 Aug 2015

·www.biospace.com

Galleon Taps Ex-Chelsea Therapeutics Chief as New CEO

August 4, 2015 By Mark Terry , BioSpace.com Breaking News Staff Horsham, Penn.-based Galleon Pharmaceuticals, Inc. announced today that Joseph Oliveto will step in as chief executive officer immediately. Oliveto replaces James Mannion , who is retiring, but will act as a strategic advisor. Galleon Pharmaceuticals focuses on products to assist with breathing problems, such as sleep apnea. The company has three products in its pipeline. Gal-021 IV for post-surgical treatment and prevention for respiratory insufficiency in apnea and other high risk patients is just starting Phase IIa trials . The other two products, GAL-160 oral and GAL-160 oral backups , are still in preclinical development for sleep apnea. The company has raised about $17.5 million in three venture capital rounds, the first for $1.5 million on Nov. 20, 2013, another $10 million on Nov. 23, 2010 and $6 million on Jan. 13, 2014. To date the company has raised about $50 million from investors, including TPG Biotech , Morgenthaler Ventures , and Healthcare Ventures . The company received $500,000 in seed funding in 2005 from BioAdvance , which runs the Biotechnology Greenhouse of Southeastern Pennsylvania . Oliveto most recently was president and chief executive officer of Chelsea Therapeutics, Inc. . During his time at Chelsea , he oversaw the company’s approval for Northera by the FDA . Northera is used to treat neurogenic orthostatic hypotension. Oliveto also was involved in the sale of Chelsea to Lundbeck Inc. . “Joe’s broad experience and proven track record in leading successful research and development and commercial teams will be of great value as we continue to build upon Galleon ’s success to date,” said Thomas Dietz , chairman of Galleon in a statement. “At the same time, we want to recognize the outstanding work that Jim Mannion did since founding the company as CEO. Thanks to his leadership and vision, Galleon is well-positioned to continue clinical studies and eventually bring these investigational therapies to market.” In September 2014, Galleon published data from a double-blind, placebo-controlled clinical proof-of-concept study for GAL-021 in the journal Anesthesiology . The focus was to examine whether GAL-021 stimulated breathing in patients on opiates common to surgery whose breathing was depressed. The drug met or exceeded the study’s goals. “There is a high unmet need for an agent to help anesthesiologists and other professionals manage the growing numbers of respiratory related complications taking place post-surgery,” said Albert Dahan , professor of anesthesiology at Leiden University Medical Center in Leiden, The Netherlands, and lead investigator of the study, in a statement. “These new data reinforce our belief that GAL-021 may be an important option for patients and providers to help protect these patients’ airways and restore breathing control. We also believe more studies are needed to confirm these initial findings.” For most people who suffer from sleep apnea, the treatment is a mechanical breathing device, or CPAP. Approximately 40 million people in the U.S. have problems with sleep apnea, which can interrupt breathing and sleep. If Galleon ’s drugs were approved, they would have a lock on the market. The company has suggested that if the drugs worked in 30 to 50 percent of sleep apnea patients, that’s a potential $10 billion market.

Phase 2Drug ApprovalExecutive Change

100 Deals 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-044 (Galleon)	Pain More	Pending
GAL-021	Respiratory Insufficiency More	Pending
GAL-475	Sleep Apnea Syndromes More	Pending
GAL-160	Sleep Apnea Syndromes More	Unknown

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