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August 22, 2017
Cytogel Pharma, LLC. announced the addition of Lynn Webster, M.D., F.A.C.P.M., F.A.S.A.M., to its Scientific Advisory Board. Dr. Webster, Vice President, Scientific Affairs, PRA, is a leading pain physician and researcher with a focus on the management of complex pain problems and addiction. He has long been an advocate for patients suffering from chronic pain, and he has fought for better education and safer therapies to address the twin crises of chronic pain and addiction in America. He is dedicated to minimizing the potential for harm from pain medications.

Dr. Webster is a past president of the American Academy of Pain Medicine (AAPM). He is the author of The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us (Oxford University Press) and co-producer of the documentary, "The Painful Truth," airing on public television stations throughout the United States. Dr. Webster earned his doctorate of medicine from the University of Nebraska and completed his residency in the University of Utah's Department of Anaesthesiology. He is board certified in anaesthesiology, pain medicine, and addiction medicine.

 

June 6, 2016
Cytogel Pharma, LLC. announced that Jack Uetrecht, M.D., Ph.D., has joined its scientific advisory board. Dr. Uetrecht is Professor of Pharmacy, Medicine and Pharmacology, at the University of Toronto and Sunnybrook Health Science Centre. He was the Canada Research Chair in Adverse Drug Reactions from 2001 to 2015 (the maximum is two 7 year terms). Dr. Uetrecht is the past recipient of Pharmaceutical Manufacturers Association Foundation Faculty Development Award and the Janssen-Ortho Award for Research. He has spent his whole career of more than 30 years on the study of idiosyncratic drug reactions, including both basic mechanistic studies and reviewing clinical cases. His background includes a Ph.D. in organic chemistry, an M.D., an internal medicine residency, and a clinical pharmacology fellowship.

 

January 28, 2015
Mr. Maglaris announced that Dr. Bob Rappaport, former director, Division of Anesthesia, Analgesia, and Addiction Products, U.S. Food and Drug Administration, has joined its scientific advisory board as a regulatory and scientific consultant. During his tenure as Director at the FDA, Dr. Rappaport on numerous occasions stated that there is a major need for novel therapeutics to treat pain. In 2013, Dr. Rappaport received the Agency's Lifetime Achievement Award for his contributions to the anesthesia, analgesia, and addiction fields by accelerating the discovery and development of new drugs with improved efficacy and safety.

 

October 22, 2014
Cytogel Pharma, LLC. announces the election by the Board of Managers of Dr. Frederick W. Telling to its Board of Managers. CEO Dean Maglaris said "we are proud to have Dr. Telling join our Board. Fred has enjoyed a long and successful career in the pharmaceutical industry and brings to our Company broad and deep experience in strategy, policy, M&A and corporate leadership." Dr. Telling is currently the Chairman of Oragenics in Tampa, Florida and a Director of Cell Therapeutics Inc. based in Seattle, Washington and Eisai N.A. Inc. in Woodcliff Lake, New Jersey. Fred held a number of high level corporate executive leadership positions at Pfizer, spanning 30 years, including Corporate Vice President of Pfizer Inc and Vice President of Corporate Strategic Planning and Policy. He oversaw the company's realignment and focus on its human and animal health business - divesting its Food Science and Medical Technology groups, while acquiring Warner Lambert, Pharmacia and various consumer product brands. Concurrently, Fred was responsible for the company's policy development and he represented the company in many industry related outside Boards, including BIO where he served on its Board for over 10 years.

Dr. Telling received his BA from Hamilton College and his Master's of Industrial and Labor Relations and Ph. D. in Economics and Public Policy from Cornell University.

 

September 25, 2014
Cytogel Pharma, LLC. Announces Presentation at the 8th Annual Pain and Migraine Therapeutics Summit in Boston on September 24, 2014, Novel mu opioid mechanisms for the potent analgesic Cyt-1010 distinguish it from morphine...

DARIEN, CT., September 25, 2014 - Cytogel Pharma announces the presentation at the 8th Annual Pain and Migraine Therapeutics Summit of a mechanism of action study conducted in the laboratory of Gavril Pasternak, MD, PhD at Memorial Sloan Kettering Cancer Center in New York City. Cyt-1010 is a chemically stabilized and peptidase resistant analog of endomorphin-1, is highly mu-selective, showing very poor affinity for delta and kappa opioid receptors.

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March 26, 2014
Cytogel Pharma, LLC. announces Dr. Robert Kaiko as scientific and clinical advisor to help plan and implement its clinical development program for Cyt-1010

DARIEN, CT., March 28, 2014 - Robert F. Kaiko, Ph.D. recently joined Cytogel Pharma as a scientific and clinical advisor on the development of its novel analgesic, an endomorphin named Cyt-1010. We are most pleased to have Dr. Kaiko join our team, stated Dean Maglaris, Cytogel CEO. We are looking forward to moving into Phase 2 clinical trials to further demonstrate the important advantages of Cyt-1010 in terms of analgesic activity and safety from the serious side effects seen with other opioids...

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October 28, 2011
Cytogel Pharma, LLC. Announces Presentation at the American Society of Anesthesiologists meeting in Chicago on October 18, 2011, Describing Results From its First Human Study, Part of the Phase I Program for Cyt-1010.

DARIEN, CT., October 28, 2011 - Cytogel Pharma, LLC. is pleased to announce today the presentation at the American Society of Anesthesiologists of study results and completed analysis of a Phase I study of Cyt-1010. Cyt-1010 is a proprietary compound and a chemically stabilized analogue of endomorphin 1, a naturally occurring pain modulator. This trial was designed as a safety study in normal healthy volunteers with additional pharmacodynamic end points. At the doses tested (up to 0.15 mg/kg) Cyt-1010 was generally well tolerated, and no severe adverse events or evidence of respiratory depression were reported. The trial included additional tests to measure sensitivity to painful stimuli and statistically significant prolongation of the threshold time for cold pain sensation was recorded at a dose of 0.1 mg/kg. Cyt-1010 is being developed for the treatment of acute and chronic pain conditions, including neuropathic pain and post-operative pain.

About Cytogel Pharma

Cytogel Pharma, LLC. is a biopharmaceutical development company based in Darien, Connecticut, focused on developing promising early-stage programs that offer significant potential both as platform technologies and high value product candidates. The company's portfolio includes novel analgesic product candidates and broadly useful polymer and hydrogel drug delivery platform technologies. Cytogel will develop products from these platform technologies to the point of demonstrated value and then license these products to other larger companies for the full scientific and clinical development and subsequent commercialization. To learn more about Cytogel, please visit our website at www.cytogelpharma.com.

 

March 2011
Cytogel Pharma, LLC. Announces Initial Results From its First Human Study, Part of the Phase I Program for Cyt-1010

Cytogel Pharma, LLC. is pleased to announce today that they have completed analysis of the initial results from a Phase I study of Cyt-1010 in humans. Cyt-1010 is a proprietary compound and a chemically stabilized analogue of endomorphin 1, a naturally occurring pain modulator. This trial was designed as a safety study in normal healthy volunteers and as such there were no deaths or serious adverse effects reported. The trial included additional tests to measure sensitivity to painful stimuli. Cyt-1010 is being developed for the treatment of acute and chronic pain conditions, including neuropathic pain. These conditions represent areas of significant unmet clinical needs.

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November 2010
Cytogel Pharma, LLC. Announces Receipt of Federal Government Grant
Cytogel Pharma, LLC. today announced that it has been awarded approximately $244,000 of federal government grants under the Qualifying Therapeutic Discovery Project program under section 48D of the Internal Revenue Code. The program provided for $1.0 billion in federal subsidies in the form of up to a 50% investment tax credit or an elective up to a 50% cash grant for certain expenses incurred during 2009 or 2010 with an individual taxpayer cap of $5.0 million. The program was oversubscribed and therefore the grant for each certified application was limited. The Company received the award granted for the project application it submitted, related to Cytogel's program targeting the treatment of pain with its novel Cyt-1010 product, which is about to enter the clinical phase of development. The Company expects to receive payment for the grant within the next few weeks.

 

September 2010
Cytogel Pharma announced that it presented a poster at the "13th World Congress on Pain" in Montreal, Quebec on September 1, 2010. Entitled "Cyt-1010: An Analog of Endomorphin-1 With Potent Antinociceptive Properties After Systemic Administration", this paper was authored by James E. Zadina, et. al. "The results show that CYT-1010 has high affinity for the mu opioid receptor, selectivity for mu relative to delta and kappa receptors, and full efficacy and high potency in activating the mu receptor. It is resistant to degradation by blood and hepatic enzymes. It is of sufficient metabolic stability to provide potent antinociception after peripheral administration to rodents by both intravenous and oral routes."

 

August 2010
Cytogel Pharma announced that it presented new scientific data on the anitinflammatory effects of Cyt-1010 in a poster at the "13th World Congress on Pain" in Montreal, Quebec on August 30, 2010. Entitled "The Synthetic Endomorphin-1 analog, Cyt-1010, Inhibits Sensory Neuropeptide Release and Acute Neurogenic Inflammation in Rat and Mouse Models", this paper was authored by Zsazsanna Helyes, et. al. Based on the data presented, "it can be concluded, that CYT-1010 effectively attenuates neurogenic inflammatory responses in which the inhibition of sensory neuropeptide release is likely to be involved. Since this type of inflammation is not affected by the presently available non-steroidal anti-inflammatory/analgesic drugs and high doses of corticosteroids induce only a moderate inhibition, this stable and highly potent EM-1 analog forms a novel drug candidate for the treatment of inflammatory conditions where pain and nociceptor activation play a pivotal role."

 

July 2009
Cytogel Pharma announces the successful completion of the pre-clinical program for its novel analgesic compound, Cyt-1010, a member of a new class of drugs based on the endomorphins. With its unique chemical structure, it is distinct from other peptides and opioids. The data from the pre-clinical program have demonstrated very good activity and a favorable safety profile. The IND application for Cyt-1010 is now in preparation.