Ongoing Clinical Researches

COVID-19

Amorphical is currently conducting a phase 1/2 prospective, randomized, placebo-controlled study to assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC), sublingually administered and by Inhalation, concomitantly with Best Available Treatment (BAT), compared to placebo and BAT for treating Moderate to Severe COVID-19 patients.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was first identified in Wuhan, China, at the end of 2019, and has rapidly spread through the entire world, resulting in the 2019–21 coronavirus pandemic. Common early symptoms of the disease include fever, cough and shortness of breath. While most cases result in mild symptoms, some progress to pneumonia and multi-organ failure. The deaths per number of diagnosed cases is estimated at between 1% and 5% but varies by age and other comorbidity factors. The wide range of national death rate is depended on geographic, genetic, National average age, socioeconomic and other factors.

Amorphical’s multisite-study for treating COVID-19 patients takes the advantage of ACC as a safe product that was already studied in 5 clinical trials for treating various diseases. The treatment in the current trial follows the same basic treatment administered to late-stage cancer patients with no severe adverse events.

ACC has been found to modulate mild acidic pH conditions, associated with numerous diseases and medical stress conditions. Acidosis conditions are also associated with SARS-CoV-2 capability to attach and transfuse into the host cells and for the virus replication. The acidic conditions are also associated with the derived respiratory inflammation syndromes in severe COVID-19 cases. This simple, straight-forward study may lead to a novel and safe treatment for COVID-19 and other corona viruses patients, increasing the recovery rates and preventing deterioration into death threatening conditions.

Cancer

 

A clinical trial Amorphical is currently conducting in Hadassah Ein Kerem hospital in Jerusalem is aimed to improve the function and welfare of terminal cancer patients (Hospice Stage). The trial includes patients who have exhausted every available treatment option and are only receiving palliative medications for pain, with an estimated life expectancy of 1-3 months.

Patients, meeting the criteria, suffering from almost any type of solid cancer can participate in this study. Other patients may apply with their medical care providers for compassionate treatment outside the study. Every patient starts by receiving a personalized dose of AMOR (ACC) powder , sublingually administered. Every week the daily calcium dose is increased by 200 mg, up to a maximum of 1800 mg/day.  In addition, every patient inhales 8 ml of ACC suspension 3 times a day.

As a next step, Amorphical intends to initiate a prospective, multicenter, phase II, randomized, active controlled, single blind study to assess tolerability, safety and efficacy of Amorphous Calcium Carbonate (ACC) on non-terminal patients, whose life expectancy would be long enough to realize ACC’s full potential.

 

“To Study the Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare Improvement in Late-stage Solid Cancer Subjects”, Rothman, J.

Improving top athletes’ performance

Improving top athletes’ performance is a critical issue that has been extensively studied. Many methods have been developed to achieve this goal. One option to improve athlete’s performance is the consumption of nutritional and performance-enhancing ergogenic supplements. Nutritional supplements are classified according to their degree of effectiveness in performance improvement.

There are available supplements that contribute to improving performance by reversing acidosis activities (increasing the blood pH) associated with intense sport activity that leads to extensive need to generate ATP and causes enhanced release of CO2, both result in increased the H+ concentration. Two supplements are commonly used to achieve performance improvement by blood’s pH modulation: (a) sodium bicarbonate (NaHCO3), which is an extracellular buffer; and (2) beta alanine (β-ALA), which increases the content of the di-peptide carnosine inside the muscle cells (intracellularly), thus lowering the internal acidity of cells. A combination of both supplements, compared to the consumption of each of them alone was found to be more effective for enhanced performance. It is important to realize that taking the high recommended doses of NaHCO3 recommended to athletes has undesired side effects, such as nausea and unpleasant feeling in the gastrointestinal tract. It also significantly increases the undesired consumption of sodium. The use of β-ALA requires administration of the supplement for a long period to affect the performance and its efficacy has been scientifically challanged.

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Amorphical’s ACC is an excellent candidate to serve as a solid pH buffer (modulator) for improving athletic performance. It has the potential to improve performance and accelerate recovery from physical exertion. ACC has already found to be beneficial for top Israeli athletes that had suffered bone and muscle injuries and chronic inflammations. They have also reported rapid return to intense practices, followed by personal record breaking.

A designed study is currently performed with an aim to examine the effect ACC, sublingually administered several days prior to performing the globally-recognized Wingate Test (WAnT), in which the following variables are measured: maximum and average power, fatigue index, and recovery from the short but intense cycling effort. The latter assessment includes measuring the rate (kinetics) of clearing the high levels of lactate in the blood, generated during the intense exercise.

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