Former Congressman Kennedy champions safer & non-addictive pain management as CYT-1010, an alternative to classical opioids, is entering Phase 2 Clinical Trials

DARIEN, CONN., USA, October 14, 2021 /EINPresswire.com/ -- Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates, dedicated to safer pain management, announced Patrick J. Kennedy, former U.S. Congressman, and founder of the national mental health nonprofit, The Kennedy Forum, has joined the firm’s Advisory Board, which is populated with other renowned voices from the medical, scientific and advocacy community.

CYT-1010 is an endomorphin compound that targets the right receptors of the central nervous system to block pain – with minimal adverse effects: In a Phase 1 clinical study, CYT-1010 demonstrated safety and significant 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

This groundbreaking approach is backed by scientific evidence that elucidates its novel mechanism of action, differentiating it from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

"We are so pleased that Congressman Kennedy is joining us as a strategic advisor," said C. Dean Maglaris, CEO of Cytogel. "The Former Congressman’s years of distinguished advocacy have given him an impactful voice to help drive forward our mutual mission of providing a safer, non-addictive option for pain management. Patrick joins us at this critical time as we take CYT-1010 into Phase 2 Clinical Development, which will take us that much closer to realizing a safer treatment for patients in pain.”

During his 16 years in the U.S. House of Representatives, Kennedy co-authored the landmark Mental Health Parity and Addiction Equity Act (Federal Parity Law), which requires insurers to cover treatment for mental health and substance use disorders no more restrictively than treatment for illnesses of the body, such as diabetes and cancer.

“With its alternative to classical opioid treatment, Cytogel is on the cusp of a major medical breakthrough—one that will quite literally save lives,” said Kennedy. “We need all hands on deck when it comes to battling the public health crisis of addiction. I’m proud to work with a company that is hyper-focused on changing the status quo.”

As founder of The Kennedy Forum, former Congressman Kennedy unites advocates, business leaders, and government agencies to advance evidence-based practices and policies in mental health and addiction. In 2017, he was appointed to the President's Commission on Combating Drug Addiction and the Opioid Crisis. He currently serves as co-chair of the Action Alliance's Mental Health & Suicide Prevention National Response to COVID-19, and co-chair of the Bipartisan Policy Center's Behavioral Health Integration Task Force.

In addition to Kennedy, Cytogel recently announce that Christopher Gharibo, MD, a leading clinical and scientific practitioner, has also joined Cytogel’s Scientific Advisory Board. Dr. Gharibo is a Professor with the Departments of Anesthesiology, Peri-Operative Care & Pain Medicine as well as Orthopedics at New York University School of Medicine and serves as the Medical Director of Pain Medicine at NYU Langone Hospitals Center.

The U.S. Trademark Certificate of Registration has been issued for Cytogel’s groundbreaking investigational stage pain medicine, CYT-1010^®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses of the primary molecular structure, salt forms, novel formulations, related species and new molecules. The Composition of Matter patent is in effect until 2038.


About Cytogel Pharma:

Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products from the endomorphin family of molecules for the treatment of moderate to severe pain, that could avoid the 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 analgesic 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. This groundbreaking approach is backed by scientific evidence that differentiates it from the existing opioids and presents an attractive alternative treatment for people in pain. It is currently being developed for use in treating post-operative pain, by IV administration.


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 this 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.

Kimberly Weinrick,
kweinrick@cytogelpharma.com
Cytogel Pharma, LLC

Kimberly Weinrick
Cytogel
kweinrick@cytogelpharma.com