Since May 2022, RMENA’s research partner, Zhittya, has been conducting Medical Research Studies with patients suffering with Parkinson’s disease, progressive supranuclear palsy (PSP) and multiple systems atrophy (MSA). These Medical Research Studies have taken place in the British Virgin Islands (BVI) where clearance has been granted to conduct those trials. The first human data (165 patients as of June 1, 2024) from the Parkinson's disease medical research studies conducted in the BVI have shown the medicine to be completely safe and well tolerated. Regarding efficacy, the medicine resulted in motor score improvements in the patients of 18% to 82% which is a very positive and a significant result. RMENA believes that there are over 2 million Parkinson’s disease sufferers in the region. 

The other brain disorders, including stroke recovery, Alzheimer’s disease, dementia, multiple sclerosis, traumatic brain injuries, MSA and PSP are all additional opportunities.

Here is a YouTube webinar on the improvement in the first human Parkinson’s disease sufferers.

Heart disease is the #1 cause of death in the world. It is estimated that in 2021 over 18 million people died of heart disease. Of that, over 1.2 million were in MENA. Cardiovascular diseases (CVDs) are the leading cause of death in the MENA region, accounting for around 34% of all deaths. Major risk factors contributing to the high CVD burden include high rates of obesity, diabetes, hypertension, smoking, physical inactivity, and unhealthy diets. Some of the highest CVD rates are found in countries like Egypt, Iraq, Syria, and Yemen.

The medicine that Zhittya is developing for RMENA, FGF-1, has been utilized in four separate human heart trials. To date, there have been no adverse events and the improvement in patients’ hearts has been material. Here is a link to an ABC News broadcast about Zhittya’s medicine growing new blood vessels in the human heart. After new blood vessel growth, angina pain was eliminated and heart function was enhanced. 

The approval of the heart medicine in the US could be several years away, however, Zhittya is in discussions with clinics in The Bahamas, Zambia and others for Medical Research Studies in those nations.

RMENA estimates that in the MENA region, there could be more than 5 million diabetic patients who have a foot ulcer and who will be in need of FGF-1 to heal their chronic ulcer. In reported Phase II clinical data on the healing of chronic diabetic foot ulcers (DFUs), the FGF-1 demonstrated the ability to heal 100% of the DFUs within 5 months. The drug has also been used for venous ulcers and we believe that it would work in many situations in which wound healing is needed such as burns, bed sores and more.

Peripheral Artery Disease (PAD), Critical Leg Ischemia (CLI) and Desert Foot are diseases caused by a lack of blood flow to the legs or feet. An estimated thirty million people in MENA suffer from blocked arteries in their legs or peripheral artery disease. In animal testing, ZGM’s drug demonstrated the ability to stimulate the growth of new blood vessels in the legs of animals with experimental PAD. We estimate that 4 million people in the MENA Territory suffer from an evil form of PAD called Critical Leg Ischemia. The condition is called critical since there is no treatment for these patients and the most likely outcome is amputation and a dramatically shortened life. The treatment of injecting FGF-1 into the troubled area and growing new blood vessels may be the only thing to extend these people’s lives. Human research studies have been approved in the British Virgin Islands for Critical Leg Ischemia. Desert Foot, also known as desert foot syndrome or desert foot mycosis, is a fungal skin infection that primarily affects the feet and is commonly seen in certain hot, dry desert regions of the Middle East. RMENA believes that FGF-1 can be part of the treatment to heal desert foot.

Lung disease is the 3rd major cause of death in the world, responsible for an estimated 14% of deaths each year. The World Health Organization (WHO) estimates that 7-9 million people die worldwide from lung disease every year. An even larger number of people in the world are affected by lung damage.  The WHO estimates that 384 million people globally were living with chronic obstructive pulmonary disease (COPD) in 2019. A study was published in Respiratory Research in 2019, that estimated that there were 2.9 million prevalent cases of COPD in the MENA region. COPD accounted for around 120,000 deaths in the MENA region in 2019. Smoking is noted as a major risk factor driving the COPD burden higher in the MENA region. Members of the FGF family have shown lung-protective activities when administered to patients with emphysema, chronic obstructive pulmonary disease (COPD), Acute Respiratory Distress Syndrome (ARDS) and other lung diseases.

Diabetes is a major public health concern in the Middle East and North Africa (MENA) region, with a high and increasing prevalence rate compared to global averages. According to the International Diabetes Federation (IDF), the MENA region had an estimated 73 million adults (aged 20-79 years) living with diabetes in 2021. This accounts for around 12.8% of the adult population in the region. Within the MENA region, some countries have particularly high diabetes prevalence rates among adults, such as Saudi Arabia (25.4%), Kuwait (25.0%), Qatar (19.8%), and the United Arab Emirates (19.3%), according to the IDF. Type 2 diabetes accounts for the vast majority (around 90%) of diabetes cases in the MENA region and is largely driven by factors such as obesity, sedentary lifestyles, and dietary habits. Several animal trials have shown that administering FGF-1 was able to reduce the glucose levels to a non-diabetic level.

Kidney disease is a significant public health concern in the Middle East region, with a relatively high prevalence compared to some other parts of the world.  The overall prevalence of Chronic Kidney Disease (CKD) is estimated to be around 9-14%, which is higher than the global average of around 10%. There is variation between countries, with some like Saudi Arabia and Bahrain reporting CKD prevalence rates as high as 20-25%. End-Stage Renal Disease (ESRD) Prevalence is also relatively high in the Middle East. Countries like Saudi Arabia, Qatar, and the United Arab Emirates have ESRD prevalence rates ranging from 500 to 800 per million population, which is among the highest globally. Several animal studies of different kidney diseases treated with FGF-1 have shown improved renal function, reduced renal injury and promoted tissue repair

As of June 1, 2024, Zhittya is working on medicines which address 23
medical indications. Of those 23 medical indications, Zhittya believes that 14
address diseases which presently have no satisfactory treatment options and are
referred to as “Unmet Medical Needs.”

• Heart disease – so-called “no option” heart patients
• Stroke recovery
• Parkinson’s disease
• Alzheimer’s disease
• Peripheral artery disease (PAD)
• Critical Leg Ischemia
• Desert foot
• Diabetic foot ulcers (DFUs)
• Venous ulcers
• Traumatic brain injury (TBI)
• Lung Diseases
• Amyotrophic lateral sclerosis (ALS)
• Chronic depression
• Multiple sclerosis (MS)
• Post-traumatic stress disorder (PTSD)
• Chronic traumatic encephalopathy (CTE)
• Vascular dementia
• Multiple systems atrophy (MSA)
• Pressure wounds (bed sores)
• Surgical wounds
• End-stage cancer
• Burns
• Male pattern baldness