Press Release: Potential Treatment for Parkinson’s & Parkinson-Like Diseases with Zolpidem: SELLAS LIFE SCIENCES GROUP HOLDS GLOBAL DEVELOPMENT & MARKETING RIGHTS
Zurich, Switzerland – Athens, Greece – December 10, 2013
- SELLAS LIFE SCIENCES GROUP takes Zolpidem into Phase II clinical studies for the treatment of Parkinson’s Disease (PD) and Progressive Supranuclear Palsy (PSP)
- Clinical studies will initially take place in Europe and, subsequently, in the USA
- Zolpidem is a potential blockbuster product and may create a therapeutic paradigm-shift for PD and PSP as shown in studies and published in peer-reviewed journals
SELLAS LIFE SCIENCES GROUP (SELLAS) announced today that it has secured the global rights of Zolpidem, a highly promising drug, in the indications of Parkinson’s Disease (PD) and Progressive Supranuclear Palsy (PSP), as well as other basal ganglia disorders, to take into Phase II clinical studies and for development, marketing, sales and distribution in the designated indications under its Intellectual Property. SELLAS will file the Zolpidem development program with the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) for fast-track designation for Parkinson’s Disease and orphan indication for PSP. Furthermore, SELLAS will develop a highly innovative new formulation of Zolpidem for the designated indications as well as the already approved insomnia market.
Parkinson’s disease puts a significant economic burden on people living with PD, their families and society with an estimated 4 million people suffering from PD and causing a socio-economic burden that exceeds EUR 30 Billion globally. This emphasizes the need for research to optimally treat Parkinson’s Disease.
Progressive Supranuclear Palsy (PSP) is a rare brain disorder, affecting about 1 in every 100,000 people over the age of 60. PSP is a chronic disease that gets worse over time, while damaging certain parts of the brain, mainly influencing eye movement.
Zolpidem is currently approved and a prescribed medication for the treatment of insomnia. It is a short-acting drug belonging to the imidazopyridine class that potentiates GABA, an inhibitory neurotransmitter, by binding to GABAA receptors at the same location as benzodiazepines.
Prelimenary studies published in the New England Journal of Medicine and the Lancet, conducted by Prof. Antonio Daniele,M.D., Ph.D, Professor at the Catholic
University of Rome and several additional observations of other clinicians published in various peer-reviewed journals reported that in patients with various Parkinsonian syndromes (including Parkinson’s disease, PD, and Progressive Supranuclear Palsy, PSP) the administration of the drug Zolpidem may remarkably improve most Parkinsonian motor symptoms. In patients with advanced PD, such remarkable motor improvement can be often observed even after a single oral dose of Zolpidem, as observed only with the most powerful anti-Parkinsonian drugs currently available. Interestingly, unlike other anti-Parkinsonian drugs, in PD patients experiencing dyskinesias, Zolpidem may also have anti-dyskinetic effects which may be very helpful in patients with advanced PD, and may even improve cognitive functioning in a subset of PD patients.
“There is a serious unmet need for new treatment strategies for patients with PD (particularly, with advanced PD) and other Parkinsonian syndromes such as PSP, since current pharmacological treatments are unsatisfactory,” said Prof. Antonio Daniele. “These studies will hopefully prove that Zolpidem is an effective drug in improving Parkinsonian motor symptoms, showing the remarkable therapeutical potential of zolpidem by means of clinical trials aimed at assessing its efficacy and safety, and thus enriching the drug portfolio pipeline for the treatment of PD, PSP and various other neurological disorders”.
Prof. Dr. Günter Höglinger, MD, Chairman of the Department of Translational Neurodegeneration at the German Center of Neurodegenerative Diseases and Professor of Neurology at the Technical University Munich, Head of the International MDS PSP Study Group stated “I am excited to be a member of the SELLAS Scientific Advisory Board. I have strong hope that Zolpidem can become a novel way of treating PSP. It is my strong desire to see new and promising drugs move along the development path for this orphan indication and this new treatment approach may change the treatment paradigm of this debilitating disease.”
SELLAS’ senior management is comprised of experts in the drug development field with successful clinical trials and out-licensing deals across various indications. “We leverage our drug development and regulatory strategies in order to optimize the success rate of the clinical development path and we are keenly interested in blockbuster-drugs, orphan drug indications and serious and debilitating indications, as well as innovative and cutting-edge treatment molecules. By combining our drug development expertise on these initial and positive pioneering studies with SELLAS’ strength in delivering breakthrough therapeutics to improve people’s lives, we have the potential to transform a therapeutic paradigm-shift of PD & PSP treatment as well as other treatments and drugs we are developing for diabetes and cancer with the most recent partnership we completed with Fosun Pharma,” said Dr. Angelos M. Stergiou, CEO & Chairman, SELLAS LIFE SCIENCES GROUP.
Prof. Daniele further points out that “Pilot studies suggest that the Zolpidem can ameliorate motor symptoms in patients with Parkinson’s Disease and Progressive Supranuclear Palsy. The results of our studies, together with other subsequent clinical observations, suggest that in patients with advanced PD (who are poorly responsive to pharmacological treatment), the anti-Parkinsonian effects of Zolpidem are particularly remarkable, whereas in such advanced patients the incidence of side effects (drowsiness) of Zolpidem is relatively low”.
“We embrace the best ideas in science, building effective collaborations of all kinds – from early stage development to late stage licensing. We currently have various active collaborations and continue to seek innovative product candidates and technologies that will complement our in-house capabilities and strengthen our product portfolio” stressed Dr. Miltos Sougioultzoglou, Vice-President, SELLAS LIFE SCIENCES GROUP.
In order to accelerate the development of PD and PSP using Zolpidem, SELLAS is going to initially conduct clinical studies at clinical sites across Europe and, subsequently, in the USA. Phase II clinical trial with Zolpidem will be initiated by the second quarter of 2014 and is expected to conclude by the end of the first quarter 2015. It must be noted that the indication(s) are patent-protected and will be developed via the 505 (b)(II) regulatory path and fast-track designation, as well as orphan drug will be seeked by the FDA and EMA.
About SELLAS LIFE SCIENCES GROUP
Σellas Life Sciences is a specialty biopharmaceutical and clinical research, science and medical oriented global group of companies, specializing in new therapy treatments within the healthcare sector. The headquarters of the company are located in Zurich, Switzerland, with offices and local facilities in Athens (Greece) and rapidly expanding throughout Europe and the mid-East. Being a healthcare-oriented global group of companies, Σellas has embraced all major aspects of the healthcare industry. The core team is highly experienced in developing drugs and devices throughout all stages to the point of approval, marketing & access, pricing & reimbursement as well as striking strong out-licensing deals with big pharmaceutical companies and bringing companies public to European and the US NASDAQ stock markets.
Σellas has a unique and innovative vision, which is ambitious, yet clear: “To practice the medicine of tomorrow, today”. In other words, Σellas incorporates innovation throughout all its activities aiming at breakthroughs that will have a significant impact on the thinking and practicing of healthcare worldwide.
For more information, please visit: http://www.sellaslifesciencessgroup.com
About Parkinson’s Disease (PD)
Parkinson’s disease (PD) is a progressive, neurodegenerative disease that belongs to the group of conditions called motor system disorders. PD cannot yet be cured and sufferers get worse over time as the normal bodily functions, including breathing, balance, movement, and heart function worsen.
Parkinson’s disease most often occurs after the age of 50 and is one of the most common nervous system disorders of the elderly. The disease is caused by the slow deterioration of the nerve cells in the brain, which create dopamine. Dopamine is a natural substance found in the brain that helps control muscle movement throughout the body.
It is estimated that approximately 4 million people have Parkinson’s Disease globally. About 1,158,000 million people have been diagnosed in Europe and 1 to 1.5 million in the US. The amount of people having Parkinson’s Disease in Europe is forecasted to double until 2030!
The economic impact of the disease is enormous. The estimated annual European cost of PD is €13.9 billion.
Other neurodegenerative disorders include Alzheimer’s disease, Huntington’s disease, and amyotrophic lateral sclerosis, or Lou Gehrig’s disease.
About Progressive Supranuclear Palsy (PSP)
Progressive Supranuclear Palsy (PSP) is a neurodegenerative brain disease that has no known cause, treatment or cure. It affects nerve cells that control walking, balance, mobility, vision, speech, and swallowing. Five to six people per 100,000 will develop PSP and although it is a rare disease, the annual cost in the 27-country European Union sums up to €1.2–2.7 billion.
Symptoms begin, on average, when an individual is in the early 60’s, but may start as early as in the 40’s. PSP is slightly more common in men than women, but PSP has no known geographical, occupational or racial preference.
PSP displays a wide range of symptoms including:
- Loss of balance.
- Changes in personality such as a loss of interest in ordinary, pleasurable activities or increased irritability.
- Weakness of eye movements, especially in the downward direction.
- Weakened movements of the mouth, tongue and throat.
- Difficulty in swallowing.
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