Newsroom & Publications

Welcome to Cytogel’s online Newsroom, offering a range of information, publications and background to the media. As a member of the media, you are invited to contact Kimberly Weinrick, Head of Communications.

About Cytogel 

Cytogel Pharma is a clinical stage biopharmaceutical company dedicated to developing and bringing to market innovative products to treat pain, safely and effectively. Founded in 2006, Cytogel has created a patent portfolio which includes a number of compositions with attractive pharmaceutical properties. Its lead compound, CYT-1010, is entering Phase 2 clinical development, following a successful Phase 1 study in humans.

As the first member of a new class of drugs, the endomorphins, CYT-1010 is a breakthrough pain medicine which in pre-clinical trials has shown to have substantially reduced addiction potential and significantly less risk of respiratory depression than has been experienced with traditional pain treatments. Cytogel believes CYT-1010 offers a transformational alternative drug treatment in pain management for the benefit and safety of patients.

Additionally, Cytogel has two patented technologies for enhancing the delivery of drugs and improving pharmacokinetics.  These technologies are biocompatible hydrogels and polymer-based gels that have potential application for a variety of uses, including therapeutic proteins and improved drug eluting coatings on medical devices.

Press Kit:

Cytogel Mission
Cytogel History and Background
CEO Bio - C. Dean Maglaris
FAQs

Media Contact:
Kimberly Weinrick

917-224-5335

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News & Publications:

September 24, 2019

William K Schmidt, PhD presented “The Challenge of Addiction and Respiratory Depression in the Treatment of Pain: A Prototypical Endomorphin as a New Approach for Moderate-Severe Pain Relief” during the 13th Annual Pain Therapeutics Summit was hosted in Washington DC on September 23-24, 2019. The conference focused on: Identifying and Advancing Novel Pain Drugs Through Clinical Development and Commercialization.

June 5, 2019_ Cytogel Pharma announces the publication of “Dilemma of Addiction and Respiratory Depression in the Treatment of Pain: A Prototypical Endomorphin as a New Approach” – Pain Medicine Journal

June 5, 2019

Cytogel Pharma announces the publication of “Dilemma of Addiction and Respiratory Depression in the Treatment of Pain: A Prototypical Endomorphin as a New Approach” – Pain Medicine Journal

Authors:

  • Lynn Webster, M.D., Past President American Academy of
  • Pain Medicine, VP Scientific Affairs, PRA Health Sciences
  • William K. Schmidt, Ph.D.,  noted authority in clinical pain  research

This scientific review article summarizes the pre-clinical and clinical development data on CYT-1010, in light of available scientific evidence for existing analgesics and those in development.  It is stated that “Conventional opioids, while effective for the treatment of moderate to severe pain, are associated with safety concerns (addiction, respiratory depression, and overdose deaths) that have been magnified by the current opioid epidemic and crisis.”

”In preclinical studies and in a single dose phase 1 study, CYT-1010 has been shown to have strong antinociceptive [analgesic] properties comparable to morphine, but with less potential for respiratory depression or reward.”

“Pain Medicine” is an official journal of the American Academy of Pain Medicine

 

February 20, 2019

Cytogel Pharma, LLC. announces the election of Steven G. Chrust to its Board of Managers.
- Darien, CT.

Dean Maglaris, CEO and Chairman stated, "I am pleased to announce the unanimous election by the Company's Board of Managers of Steven Chrust to its Board. Steven has been closely involved with Cytogel from its early days and has been an invaluable Board observer for many years. Steven brings extensive experience in business, management and finance to the Board. He will be taking the seat vacated by the recent and sad passing of E. Bulkeley Griswold who had been on the Board since its inception.

Steven is founder and Senior Managing Partner of Centripetal Capital Partners (www.centricap.com) a private equity investment firm founded in 2004. He is also Founder and President of SGC Advisory Services, Inc., since 1991. Mr. Chrust serves on several boards, including as Chairman of APJeT, Inc. and IMCS. He is a member of the Association for Investment Management and Research and the New York Society of Securities Analysts. He has lectured at the Harvard Business School and testified before Congress concerning the break-up of AT&T, and before state public utility commissions on various regulatory matters. In 1994, he co-founded WinStar Communications, Inc., a facilities based local telecommunications provider utilizing fixed wireless technology and served as its Vice Chairman until the end of 1998. Mr. Chrust also served as Chairman of Worlds.com between 1999-2001. He began his career in 1970, at Sanford C. Bernstein & Co., Inc., a financial institution handling more than $400 billion in client assets, currently known as AllianceBernstein. While at Bernstein, he was Director of Technology Research and ranked in the top tier of telecommunications analysts for more than a decade by Institutional Investor and ranked the #1 analyst in the sector for five consecutive years in their all-star ranking. Mr. Chrust is a graduate of Bernard M. Baruch College of the City University of New York and attended its business graduate school.

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 for the treatment of pain. Cytogel will develop products to the point of demonstrated value, proof of concept stage, 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

 

Feb 05, 2019

Cytogel Pharma Announces Receipt of FDA Authorization to Commence Phase 2 Development for its Atypical Opioid, CYT-1010

- Company announces initial path forward to phase 2 clinical studies on CYT-1010

DARIEN, Conn., Feb. 5, 2019 /PRNewswire/ -- Cytogel Pharma, LLC. today announced receipt of the official response from the U.S. Food and Drug Administration (FDA) regarding the Company's amendment to the Complete Response Letter (CRL) for the CYT-1010 Investigational New Drug (IND) application.

FDA has agreed that the Company may proceed with its phase 1a/2a study protocol titled, A Randomized Double-Blind, Single-Dose, Placebo-Controlled Pharmacokinetic and Proof-of-Concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and the Analgesic Efficacy and Tolerability of CYT-1010 vs. Morphine in Subjects with Moderate to Severe Pain after Third Molar Extraction.

The FDA issued authorization that allows this study to proceed. This will be an important proof of concept study and dose ranging study to demonstrate the effectiveness and safety of CYT-1010 in both volunteers and patients with significant pain. The FDA indicated that, upon completion of the above study, the Company should submit data to the Division for advancing to higher doses of CYT-1010, hence a partial clinical hold (PCH) in development will be in effect. The Division will review these data before lifting the PCH and allowing higher doses of CYT-1010.

"We are pleased with the productive dialogue with the FDA and their decision to authorize the initiation of phase 2 development of CYT-1010 by approving this first study protocol, opening a pathway to full clinical development of CYT-1010. This is an important step forward for the Company. We believe the design of the phase 1a/2a study will allow for demonstration of safety and efficacy of this novel candidate in the treatment of post-operative pain," said C. Dean Maglaris, President and Chief Executive Officer. "Our mission is to address the needs of post-operative pain treatment, by providing effective analgesia that would not be as limited by the serious side effects of the classical opioids, namely respiratory depression and addiction. This is our objective for CYT-1010, based on its mechanism of action that is novel among opioids."

The Company also announced that it is currently completing a bridge financing, which will shortly lead to a follow-on round of financing to fund its development programs. If completed, management expects these financings should be sufficient to fund operating expenses and project expenditure requirements into first quarter 2022.

About Cytogel Pharma

Cytogel Pharma is a biopharmaceutical company focused on developing promising early-stage, novel products for the treatment of moderate to severe pain, that could avoid the classical serious side effects of existing opioids and other analgesics. The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical opioid with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. It is currently being developed for use in treating post-operative pain, by IV administration. The Company's portfolio also includes broadly useful polymer and hydrogel drug delivery technologies, which can be useful in enhancing the pharmacokinetics of other drugs.

Disclosure Notice

CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of a product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

September 7, 2018

C. Dean Maglaris, CEO of Cytogel Pharma, announced today that Alan W. Dunton, M.D. has been named to the Board of Cytogel. Dean stated that "Dr. Dunton brings a depth and breadth of experience and leadership throughout his accomplished career in the pharmaceutical industry and will add significant value to the development of the Company's compounds for moderate to severe pain, starting with CYT-1010. He has worked at the highest level of research and development and has brought many products through full development, including drugs for the treatment of pain."

Dr. Dunton has devoted his 35-year career to the discovery and development of new prescription and OTC drug products. He is a creative and visionary leader who has successfully translated his scientific and clinical/medical knowledge into developing and achieving approval of over 20 commercially successful Rx and OTC drugs. He has led major pharma R&D and Regulatory divisions as well as has been CEO/COO of both public and private biotechnology companies. He was the President and Managing Director of the Janssen Research Foundation - the R&D and Regulatory arm of the pharmaceuticals division at Johnson and Johnson. He has also been at Roche, Syntex, Novartis (as CIBA-GEIGY) and Purdue.

Dr. Dunton holds a M.D. from New York University School of Medicine, where he completed his residency in internal medicine. He was a Fellow in Clinical Pharmacology at the New York Hospital/Cornell University Medical Center. He is a diplomat of the American Board of Internal Medicine and currently licensed to practice medicine in New Jersey and New York. He received his Bachelor of Science degree in biochemistry, magna cum laude, from State University of NY at Buffalo. In 1987, Dr. Dunton was awarded The Nellie Westerman Prize from the American Federation for Clinical Research for his research in medical ethics.

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 for the treatment of pain. Cytogel will develop products to the point of demonstrated value, proof of concept stage, 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.

August 22, 2017

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.

 

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FAQs - Frequently Asked Questions

Cytogel was founded in 2006 as a Connecticut Limited Liability Corporation.

Dean Maglaris CEO & Chair of Board of Managers
Alan W. Dunton, MD Chief Clinical Advisor
Ted Maione, PhD Chief Scientific Officer
James Hamsher, PhD Head, Licensing & Business Development
Mary Driver Director, Clinical Development Operations

Our lead compound, CYT-1010, is entering Phase 2 clinical development, following a successful Phase 1 study in humans. As the first member of a new class of drugs, the endomorphins, CYT-1010 is a breakthrough pain medicine.

In clinical studies CYT-1010 has demonstrated safety and analgesic activity.

In preclinical studies, at therapeutic doses, it has been shown to provide:

  • Safe and effective pain relief
  • Impressive anti-inflammatory effects
  • Little to no addiction potential
  • No respiratory depression

Cytogel believes CYT-1010 offers a transformational alternative treatment in pain management that could ultimately provide greater relief and better outcomes for patients.

Cytogel’s lead compound, CYT-1010 has a novel mechanism of action, preferentially activating the endomorphin receptor, which is associated with a greater margin of safety and powerful pain relief.  CYT-1010 is an analogue of a naturally occurring peptide, endomorphin 1, produced in the human body. The chemical structure of CYT-1010 is unrelated to traditional pain drugs, and therefore cannot be chemically converted to known drugs of abuse.

Cytogel has achieved key milestones by developing CYT-1010 to the point of entry into Phase 2 clinical testing.  The FDA has approved the first study protocol for Phase 2 testing of CYT-1010, a study which will focus on demonstrating effectiveness and safety of CYT-1010 in patients with significant pain.

Cytogel has identified a number of additional new endomorphin based pain drugs that are included in its patent filings, that show promise for further development as second generation analgesics.

Yes, Cytogel has patents issued and patents pending in the US and several other countries, that are key to future roll-out plans, providing exclusivity through the late 2030s.

This material does not constitute an offer to sell, nor is it a solicitation to buy any securities. The securities may be offered only through the use of a confidential private placement memorandum which contains information relevant to the risks and / or merits attendant to such investment, which information is not contained herein. For more information contact C. Dean Maglaris, CEO at .