Pipeline
In late 2011 we expect clinical proof-of-concept data from three IND-ready development candidates, each with the potential of being a first- to-market, best-in-class product.
GAL-021: GAL-021 is a small molecule for intravenous administration designed to support respiratory drive in surgical and critical care patients. The use of anesthetic, analgesic and sedative drugs individually or in combination produce a well-known respiratory depression. For example, in patients receiving opioids such as morphine GAL-021 could "decouple" the analgesic and respiratory depression effects enabling physicians to better alleviate pain without the well-known fear of respiratory collapse. There are a variety of other medical conditions where short-term respiratory drive support could provide patient benefit by avoiding the need for intensive care to monitor respiratory drive, reduce the need for intubation, protect patients with compromised respiratory drive (sleep apnea, elderly, chronic opiate therapy, COPD, mechanical ventilation).
GAL-021 is covered by composition of matter patent protection.
GAL-054: GAL-054 is a small molecule that is being evaluated for injection and oral administration. We believe GAL-054 will have application in providing respiratory drive support in a variety of clinical conditions such as: COPD exacerbation, apnea in premature babies, opioid overdose and certain types of sleep apnea. We believe the injectable form of GAL-054 will be eligible for 505(b)(2) classification by the US Food and Drug Administration providing an abbreviated pathway to marketing approval.
GAL-044: GAL-044 is a small molecule being evaluated as a preventative medicine for surgical pain. The ability to prevent surgical pain offers physicians and patients a variety of benefits including greater patient comfort and less exposure to the risks associated with narcotic analgesics (respiratory depression, nausea & vomiting, sedation). Enabled by a breakthrough in chemistry synthesis by Galleon scientists, it is effective in both injectable and oral routes of administration and works through a unique mechanism of action. We believe a single dose of GAL-044 may prevent surgical pain for several days. The effect of GAL-044 in chronic care settings is also under evaluation.
Patients who will benefit from breathing control medicines
It is estimated that 30 percent of the population is at risk for some type of breathing control disorder. In the United States about 18 million patients have sleep apnea. Current treatment is surgery or use of a positive pressure mask when sleeping. There are many subtypes of sleep apnea and its treatment will emerge as a key strategy to manage patients with diabetes, heart failure and/or hypertension
It is estimated that 30 percent of the population is at risk for some type of breathing control disorder.
Sleep Apnea: In the United States alone, approximately18 million patients have sleep apnea. Current treatment is surgery or use of a positive pressure mask when sleeping. There are many subtypes of sleep apnea and its treatment will emerge as a key strategy to manage patients with diabetes, heart failure and/or hypertension
Drug-Induced Respiratory Depression: Patients treated with anesthetic, analgesic or sedatives in association with surgery (12 million) or medical procedures (17 million) (e.g., colonoscopy, angiography, bronchoscopy) are also at risk for breathing control dysfunction. Galleon medicines are designed to provide an extra measure and safety and/or shorten hospitalization times especially for higher risk patients.
COPD: Breathing control dysfunction is also common in chronic obstructive pulmonary disease (COPD). There are approximately 15 million COPD patients in the United States. These patients often have flare ups that require emergency room visits and sometimes use of costly mechanical ventilation. A Galleon medicine may allow physicians an additional strategy to avoid mechanical ventilation and the associated intensive care costs.
Neonatology: Premature babies often have apneas where they stop breathing. This potentially life-threatening condition necessitates care in a neonatal intensive care unit where the current drug of choice is caffeine. However, caffeine has a series of limitations that drive up hospitalization costs and doctors often cite the need for an alternative that is more cost effective.
Selected Reading
Books
Pharmacology and Pathophysiology of the Control of Breathing. Eds. Ward, DS, Dahan A, Teppema, LJ. Volume 202 Lung Biology in Health and Disease. Taylor & Francis, New York, 2005.
New Frontiers in Respiratory Control XI Annual Oxford Conference on Modeling and Control of Breathing. Eds. Homma, I, Onimaru, H, Fukuchi, Y. Advances in Experimental Medicine and Biology 669. Springer New York, 2010
Obstructive Sleep Apnea, Pathophysiology, Comorbidities, and Consequences. Ed. Kushida, CA. Sleep Disorders Vol. 3. Informa New York 2007
Genetic Basis for Respiratory Control Disorders. Ed. Gaultier, C. Springer New York, 2008
Sleep-Related Breathing Disorders, Experimental Models and Therapeutic Potential. Eds. Carley, DW, Radulovacki, M. Lung Biology in Health and Disease Vol. 171. Marcel Dekker, New York 2003
Oxygen Sensing, Responses and Adaption to Hypoxia. Eds. Lahira, S, Semenza, GL, Prabhakar, NR. Lung Biology in Health and Disease Vol. 175 Marcel Dekker New York 2003
Journal Publications
Obesity and Upper Airway Control During Sleep. J Appl Physiol 108:430-435, 2010
Pharmacological approaches to the treatment of obstructive sleep apnea. Expert Opin Investig Drugs, 18(5):647-656, 2009
Mechanisms of atelectasis in the postoperative period. Best Practice & Research Clinical Anesthesiology 24: 157-169, 2010
Continuous Oximetry/Capnometry Monitoring Reveals Frequent Desaturation and Bradypnea During Patient-Controlled Analgesia. Anesth Analg 105: 412-8, 2007
Influence of anaesthesia and analgesia on the control of breathing. Br J Anaesthesia (1:40-9, 2003
Volatile anesthetics and the hypoxic ventilatory response: effects, clinical implications, and future research. Sem Anesthesia, Periop Med and Pain 26:49-57, 2007
Pathophysiology of Sleep Apnea Physiol Rev 90:47-112, 2010
Pathogenesis of Obstructive and Central Sleep Apnea Am J Respir Crit Care Med 172: 1363-70, 2005
Neuromodulation of hypoglossal motoneurons during sleep Respir Physiolo Neurobiol 164:179-96, 2008
Update in Sleep Medicine Am J Respir Crit Care Med 181: 545-549, 2010
Sleep Apnea and Cardiovascular Disease J Am Coll Cardiol 52: 686-717, 2008