A Phase 2, Prospective, Multinational, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of AMOR-1 as a Treatment of Hypocalcemia Associated With Hypoparathyroidism by Replacement of Currently Used Calcium Supplements (CS) in Adults.

This clinical trial aims to evaluate the efficacy and safety of AMOR-1, consisting of Amorphous Calcium Carbonate (ACC) as the active drug substance, in treating hypocalcemia in adults with hypoparathyroidism.

开始日期2024-09-01

申办/合作机构

Amorphical Ltd.

NCT02864784 / Withdrawn临床1期

A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis

Studies objectives:
To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below:
Safety and Tolerability:
Adverse events (AEs) and serious AEs
Safety laboratory measurements
Hypercalcemic and hypercalciuric episodes
Treatment withdrawal due to AEs and overall
Efficacy:
Skeletal Related Events (SREs)
Measurable and evaluable disease progression
Progression Free Survival (PFS)
Pain assessment via the VAS scale

开始日期2022-06-01

申办/合作机构

Amorphical Ltd.

NCT04900337 / Completed临床1/2期

A Phase 1/2 Prospective Randomized Placebo Controlled Study to Assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Administered Sublingual and in Inhalation Concomitantly With BAT (Best Available Care) as Compared to Placebo and BAT for the Treatment of Moderate to Severe COVID-19 Patients.

This is a phase I/II study with Amorphous Calcium Carbonate (ACC) administered sublingual and in Inhalation concomitantly with BAT (Best Available Care) as Compared to Placebo and BAT for the treatment of Moderate to Severe COVID-19 patients. The purpose of this study is to assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC).

开始日期2021-02-09

申办/合作机构

Amorphical Ltd.

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项与 Amorphical Ltd. 相关的文献（医药）

2024-05-01·Life sciences in space research

Amorphous calcium carbonate enhances osteogenic differentiation and myotube formation of human bone marrow derived mesenchymal stem cells and primary skeletal muscle cells under microgravity conditions

Article

作者: Ben, Yossi ; Blum, Yigal Dov ; Natan, Yehudit ; Ecker Cohen, Orit ; Neuman, Sara ; Bavli, Danny ; Amselem, Shimon ; Levy, Almog

Astronauts are exposed to severely stressful physiological conditions due to microgravity and increased space radiation. Space environment affects every organ and cell in the body and the significant adverse effects of long-term weightlessness include muscle atrophy and deterioration of the skeleton (spaceflight osteopenia). Amorphous Calcium Carbonate (ACC) emerges as a promising candidate for prevention of these effects, owing to its unique physicochemical properties and its potential to address the intricately linked nature of bone-muscle crosstalk. Reported here are two studies carried out on the International Space Station (ISS). The first, performed in 2018 as a part of the Ramon-Spacelab project, was a preliminary experiment, in which stromal murine cells were differentiated into osteoblasts when ACC was added to the culture medium. A parallel experiment was done on Earth as a control. The second study was part of Axiom-1's Rakia project mission launched to the ISS on 2022 utilizing organ-on-a-chip methodology with a specially designed autonomous module. In this experiment, human bone-marrow derived mesenchymal stem cells (hBM-MSCs) and human primary muscle cells were cultured in the presence or absence of ACC, in duplicates. The results showed that ACC enhanced differentiation of human primary skeletal muscle cells into myotubes. Similarly, hBM-MSCs were differentiated significantly better into osteocytes in the presence of ACC leading to increased calcium deposits. The results, combined with previous data, support the use of ACC as an advantageous supplement for preventing muscle and bone deterioration in outer space conditions, facilitating extended extraterrestrial voyages and colonization.

2013-01-01·Health

Bone loss prevention in ovariectomized rats using stable amorphous calcium carbonate

作者: Martin, Berdine R. ; Waltman, Eitan ; Weaver, Connie M. ; Bar-David, Elad ; Stepensky, David ; Shechter, Assaf ; Aflalo, Eliahu D. ; Berman, Amir ; Shaltiel, Galit ; Sagi, Amir ; Meiron, Oren E.

In assessing the relationship between calcium supplementation and maintaining bone mass or reducing the risk of fracture, the effectiveness of calcium supplementation has never been decisive.Freshwater crayfish rely on amorphous calcium carbonate (ACC), an instable polymorph of calcium carbonate, as the main mineral in the exoskeleton and in the temporary storage organ, the gastrolith.Inspired by the crayfish model, we have previously shown an increase in calcium bioavailability in rats administered with synthetic stable ACC vs. crystalline calcium carbonate (CCC).The current study compared the effects of amorphous calcium derived from either gastrolith or synthetic ACC with those of crystalline calcium, found in com. CCC or calcium citrate supplements, in a bone loss prevention model.Rats were subjected to either sham or ovariectomy (OVX) operation (n∼20/group) followed by administration of food pellets supplemented with 0.5% calcium from either source over 12 wk.Micro-computed tomog. (μCT) and histomorphometric analyses revealed bone loss prevention by both gastrolith and ACC treatments, manifested by an increase in morphometric bone parameters, compared to both CCC- and calcium citrate-treated groups.Both gastrolith and ACC treatments resulted in bone formation in the tibia cancellous bone, indicated by dynamic histomorphometry parameters, compared to either the CCC or calcium citrate treatments.Levels of urine deoxypyridinoline (DPD), suggested an anti-resorptive effect of ACC, which was also the only treatment that led to a significant increase in vertebral mech. strength, as supported by μCT anal. of topol. and orientation parameters of the vertebral trabeculae.To our knowledge, such levels of bone loss prevention by calcium supplements have never been reported.These findings thus suggest the potential of both natural (crayfish gastrolith) and, to a greater extent, synthetic ACC sources for the prevention of metabolic bone disorders and possibly of osteoporotic processes.

2011-02-01·Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1区 · 医学

Solubility and bioavailability of stabilized amorphous calcium carbonate

1区 · 医学

Article

作者: Stepensky, David ; Bar-David, Elad ; Shechter, Assaf ; Aflalo, Eliahu D ; Berman, Amir ; Sagi, Amir ; Meiron, Oren E

Abstract:

Since its role in the prevention of osteoporosis in humans was proven some 30 years ago, calcium bioavailability has been the subject of numerous scientific studies. Recent technology allowing the production of a stable amorphous calcium carbonate (ACC) now enables a bioavailability analysis of this unique form of calcium. This study thus compares the solubility and fractional absorption of ACC, ACC with chitosan (ACC-C), and crystalline calcium carbonate (CCC). Solubility was evaluated by dissolving these preparations in dilute phosphoric acid. The results demonstrated that both ACC and ACC-C are more soluble than CCC. Fractional absorption was evaluated by intrinsically labeling calcium carbonate preparations with 45Ca, orally administrated to rats using gelatin capsules. Fractional absorption was determined by evaluating the percentage of the administrated radioactive dose per milliliter that was measured in the serum, calcium absorption in the femur, and whole-body retention over a 34-hour period. Calcium serum analysis revealed that calcium absorption from ACC and ACC-C preparations was up to 40% higher than from CCC, whereas retention of ACC and ACC-C was up to 26.5% higher than CCC. Absorbed calcium in the femurs of ACC-administrated rats was 30% higher than in CCC-treated animals, whereas 15% more calcium was absorbed following ACC-C treatment than following CCC treatment. This study demonstrates the enhanced solubility and bioavailability of ACC over CCC. The use of stable ACC as a highly bioavailable dietary source for calcium is proposed based on the findings of this study. © 2011 American Society for Bone and Mineral Research.

项与 Amorphical Ltd. 相关的新闻（医药）

2023-11-27

·PRNewswire

Amorphical brings Scientific Breakthrough - Treating and Curing Chronic Inflammatory and Oncological Diseases

NES-ZIONA, Israel, Nov. 27, 2023 /PRNewswire/ -- An exclusive initiative by the Israeli biotechnology company Amorphical brings a breakthrough approach to treating a variety of chronic inflammatory and oncological diseases. Scientific Development and Breakthrough Amorphical has developed a pioneering technology to produce amorphous nano-minerals. The unique structure of these amorphous nano-minerals enables the efficient and rapid absorption of essential minerals in the body. Amorphous nano-minerals also possess a unique ability to stimulate healing mechanisms within the target damaged tissues. Amorphous Calcium Carbonate – Amorphical's Revolutionary Leading Product Calcium is a vital mineral for various physiological activities: bone formation, nerve conductivity, muscle function, boosting the immune system, and many other activities. Carbonate is a crucial molecule for maintaining the body's pH balance by neutralizing excess acidity. Treating the Cause for Disease, Not Just the Symptom Modern lifestyle, characterized by stress, unbalanced diet, and an increase in life expectancy, results in a reduced production of bicarbonate, essential for the proper function of the body. Consequently, the elevated tissue acidity impairs the ability to regulate inflammatory processes, ultimately leading to the development of chronic inflammatory as well as oncological diseases. Due to its unique structure and dissolving properties, unlike the crystalline mineral, the amorphous calcium carbonate can directly target inflamed or cancerous tissues. When amorphous carbonate calcium reaches the inflamed tissue, a neutralizing reaction occurs within the acidic environment. The resulting neutral environment does not support the inflammatory processes, leading to the desired healing. Neutralizing the acidic environment is also crucial in treating oncological diseases. Most oncological diseases are characterized by anaerobic respiration of cancer cells, creating an acidic environment within the tumor. This acidic environment supports the rapid division of cancer cells and the development of metastases, while preventing the immune system from attacking and eliminating the cancer cells. Neutralizing the acidic environment in the cancerous tissue by amorphous calcium carbonate inhibits the enhanced metabolic activity of the cancer cells, required for their rapid division. In parallel to the reduction in cancer cell proliferation, the neutralization of the acidic environment within the tumor allows the immune cells to resume their activity, and attack and destroy the cancer cells. To date, this is the sole technology capable of treating and curing a wide range of oncological diseases by transforming the cancerous environment into a healthy environment. Comparison to Current Medications Current medications for chronic inflammatory diseases primarily aim to alleviate symptoms rather than target the disease accelerator, which is the acidic environment within the inflamed tissue. In contrast, amorphous calcium carbonate neutralizes the acidic environment specifically in the inflamed tissue, and thus enables the healing of the inflammation. Conditions Suitable for Treatment by Amorphous Calcium Carbonate The innovative treatment with amorphous calcium carbonate promotes prompt and effective recovery across a variety of diseases: 1. Crohn's Disease, Multiple Sclerosis, Osteoporosis, Arthritis, Pulmonary diseases, and other chronic inflammatory diseases. 2. A wide range of oncological diseases including breast, prostate, colon, liver cancers, and more. 3. The treatment has proven to be highly effective in managing COVID-19. 4. The treatment significantly slows down aging processes and substantially improves the quality of life. Selected Scientific Publications on the Medical Activity of Amorphical's Nano-Amorphous Calcium Carbonate: Lung Cancer: Amorphous Calcium Carbonate Shows Anti-Cancer Properties That are Attributed to Its Buffering Capacity. Cancers (Basel). 2023 Jul 26;15(15):3785 Treatment for COVID-19: Sublingual and Inhaled Amorphous Calcium Carbonate for Hospitalized Patients with SARS-CoV-2: A Phase 1/2 Clinical Study. J Clin Trials. 2023 Vol.13 Iss. 4 No: 1000551 Effect on Mouse Embryos: The effect of amorphous calcium carbonate as a culture media supplement on embryonic development of murine sibling embryos. J Assist Reprod Genet. 2023 Oct;40(10):2409-2418 Additional articles describing the treatment with Amorphical's amorphous nano-minerals are presented on the company's website. For more information, please contact: Noga Nadel Erental - [email protected] Logo -

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