Discovering Novel Therapies for Treatment Resistant Depression and Other Dopamine Related Diseases
Low Dose Naltrexone for Enhanced Dopamine Signaling
PharmoRx Therapeutics' patented method for improving dopamine signaling involves the use of low dose naltrexone (LDN) in combination with widely prescribed dopamine-related medications that are currently being used to treat a variety of central nervous system diseases, such as depression. We believe that our discovery provides us with a platform for enhanced therapies for several types of depression, as well as a number of impulsive compulsive disorders such as binge eating disorders and cocaine addiction.
First Clinical Study
Our first study was performed to quantitatively confirm our hypothesis that LDN could prevent or reverse desensitization at D2 and D3 receptors, allowing sustained efficacy of dopaminergic agents at lower doses. Our research then led us to select treatment resistant depression as the first disease to target with our novel platform of enhanced dopaminergic signaling, particularly given that an effective therapy for treatment resistant depression (TRD) has eluded the pharmaceutical industry for decade.
Phase IIa Clinical Study
In collaboration with Dr. Maurizio Fava, Deputy Chair of the Psychiatry Department at the Massachusetts General Hospital (MGH) and Dr. David Mischoulon, Director of the MGH Depression Clinical and Research Program (DCRP), PharmoRx Therapeutics sponsored a proof-of concept study, The placebo-controlled, double-blind Phase IIa clinical study successfully demonstrated the efficacy and effect size of our combination therapy consisting of LDN and dopaminergic medications in treating patients with relapsing depression. Several patients achieved remission in 3 weeks.
Based on the positive results of this trial, with large effect sizes, Dr. Mischoulon presented the results at the annual APA and ASCP meetings.
Link to our research poster here.
PharmoRx Therapeutics is collaborating with Dr. Fava and Dr. Mischoulon to develop protocols and trial design plans to conduct a phase IIb trial for TRD.
We are also engaged in research of other therapeutic areas for its proprietary enhancement of dopamine active medications for the following diseases:
Other Depressive Disorders
Parkinson’s Disease with Depression
Impulsive Compulsive Disorders
Our mission at PharmoRx Therapeutics is to create pharmaceutical therapies for treating dopamine-related central nervous system diseases.
Depression has continued to challenge the medical community. Although there are some known treatments for depression, the relapse rates are unacceptably high, and new treatment options are desperately needed.
What we are doing is crucial for 350 million patients, as depression is the leading cause of disability worldwide. The burden of depression and other mental health conditions is on the rise globally.
Our first quest is to develop a medication for Treatment Resistant Depression (TRD), a disease that affects approximately 4.8 million people in the US, and over 17 million throughout the world. A successful cure continues to elude our industry and these millions of patients.
Based on research and clinical results to date, we believe that we have found the key that unlocks the door to a successful therapy for TRD, as well as a promising platform for other diseases such as Major Depressive Disorder (MDD), Depression in Parkinson’s, and Impulsive Compulsive Disorders (ICD).
With our patented pharmacologic innovation and further clinical development, we intend to restore a happy and productive life to millions of people afflicted with TRD, MDD, ICD and other CNS diseases.
David Bear, MD
Chairman of the Board of Directors
David's discovery, together with the pharmacologic insights of Dr. Robert Kessler, led to a method of reversing desensitization to agonists at dopamine 2 and 3 receptor subtypes, the company’s powerful platform in neuropharmacology.
David is a Distinguished Fellow of the American Board of Psychiatry and Neurology, having conducted extensive research in neurological psychiatry with Norman Geschwind, the late James Jackson Professor of Neurology at Harvard Medical School. He is a graduate of Harvard College and Harvard Medical School, a Fellowship at NINDS, and completed his Psychiatric Residency at MGH. He served on the faculties of Harvard, Vanderbilt, and the University of Massachusetts Medical Schools, where he was Professor of Psychiatry.
David is a serial entrepreneur, founding Covectra, a serialization company to combat opioid diversion and counterfeits, and MedSentry, Inc, which provides a complete physician-to-patient medication adherence system. He has been awarded multiple patents for work related to the founding of these companies.
Robert Kessler, MD
Chief Medical Advisor
Bob is a co-founder PharmoRx Therapeutics and a member of the Board of Directors. Together with David Bear, he patented the invention to develop novel uses of established dopamine-active agents in neuropsychiatry.
Bob is a neuroradiologist with over 30 years of experience in both PET and MRI imaging, both at a clinical and research level. He holds patents both in development of dopamine D2 receptor ligands and in development of MRI pulse sequences.
His PET research has included studies of cerebral metabolism, development of dopaminergic and glutamatergic PET radioligands for CNS neurotransmission, schizophrenia, mechanism of action of antipsychotic drugs, reward function, psychostimulant drug abuse, and obesity. His current interests include the interaction of dopaminergic and glutamatergic neurotransmission in psychiatric and neurological disorders.
Bob was a Professor of Radiology and Director of Neurochemical Brain Imaging and PET Neurotracer Development at the University of Alabama at Birmingham. Previously, he was the Roentgen Professor of Radiology at the Vanderbilt University School of Medicine where he held a number of positions including Director of Neuroradiology and Positron Tomography.
Bob attended Yale University as an undergraduate and received his M.D. from Yale School of Medicine. He subsequently joined a lab at the National Institutes of Health as it became the first to use PET scans to visualize activity of the brain.
President & Chief Executive Officer
Steve is a co-founder of PharmoRx Therapeutics and also the President & CEO of Covectra, Inc., which provides serialization-based brand protection solutions to the pharmaceutical, medical device and food industries. Steve also serves on the Board of Directors of PTI, Covectra, and MedSentry, Inc.
Steve has over 30 years of experience in international business development and program management. He has extensive experience covering pharmaceutical product development, along with processing and packaging machinery, pharmaceutical security technologies and integrated systems.
After graduating from the U.S. Naval Academy, Steve's professional career began in the U.S. Navy, serving in the submarine force for seven years. While in the Navy, Steve studied Russian at the Defense Language Institute, and worked in the naval intelligence community.
After leaving the Navy and getting his MBA from the Yale School of Management, Steve served as a senior executive in a number of industries, including packaging and printing machinery, defense engineering, and recording media.
Vice President & General Manager
Carl leads business development & licensing efforts and early stage development of novel therapies for the central nervous system, including Treatment Resistant Depression and Parkinson’s Disease.
Carl has over 30 years of biopharma industry experience with both big pharma (Pfizer, Roche, BMS) and emergent companies (Anesta, Cephalon, Kyowa, Dainippon Sumitomo Pharma America, Sunovion, and Braeburn). He held executive level positions in the areas of new product development, CMC regulatory filings, and supply chain operations. He has overseen the development of strategies and commercial Rx product launches across the US, Europe and Asia. Carl successfully launched major branded drugs (Procardia XL, Diflucan, Norvasc, Zithromax, Zoloft, Cardura, Actiq and Latuda) globally, ensuring effective global and regional regulatory filings and approvals.
In 2004, Carl founded his consulting firm, Global Pharma Consulting LLC, to help small to mid-sized companies commercialize Rx products.
Carl has a B.S. with distinction from Cornell University, an M.S. from University of Illinois, & an M.B.A. from the Stern School at New York University.
John has a distinguished career in the pharmaceutical industry, most recently as Chief Commercial Officer of the $2.5 billion Sanofi Aventis Global Oncology Division. In this capacity, John led a 1,500 person global team that actively promoted Sanofi’s oncology products in 93 countries, and was also responsible for the global Sanofi oncology marketing team. Under John’s leadership, Sanofi developed and launched a number of oncology products, including Jevtana for prostate cancer, Zaltrep, Jak2, and the Genzyme Transplant and Oncology portfolio.
Prior to his tenure as head of the Oncology business unit, John was General Manager for the Sanofi Aventis Metabolism (Diabetes) Business Unit, responsible for $2 billioon in revenue. He oversaw the launch of Lantus, the leading insulin product in the US, as well as the OptiClik insulin device and Apidra.
Before his tenure at Sanofi, John's held executive level positions at Aventis, Marion Merrell Dow, and Marion Laboratories.
John is active as a Board member on the National Patient Advocate Foundation, the UICC Board of Corporate Advisors, and is a Member of the CEO Roundtable on Cancer. He is a former Board Member of the following organization: Massachusetts Biotechnology Council, Industry Advisory Board for the American Diabetes Association, Center for Healthcare Supply Chain Research, and Somerset Regional Medical Center.
John received a B.A. in Business Administration/Economics – Summa Cum Lauda – from Stonehill College and an M.B.A. from Rockhurst University.
Chief Financial Officer
Gary has over 20 years of experience in finance and accounting, strategic planning, financial planning & analysis, and new product development across healthcare, financial services, and manufacturing industries.
Gary joined PharmoRx Therapeutics from Fidelity Investments, where he was Senior Director in the Strategy and Planning Office. His broader experience includes senior level finance positions at Health Dialog, American Express, and Unilever with vast experience in leading high-performing FP&A and accounting teams, strategic planning, contract negotiations, customer pricing, and financial model formulation.
Gary has a B.S. in Finance from Rutgers University and an M.B.A. in Finance from the Kelley School of Business at Indiana University,
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