Pharmaceutical Pipeline

Amorphical has successfully managed to synthesize and produce nanoparticulate amorphous calcium carbonate (ACC) having log-term stability. Amorphical’s ACC is the only non-crystalline calcium carbonate supplement in the world. The stabilized ACC technology is based on biomimicry of the gastrolith in which the blue crayfish stores stabilized ACC. The stabilized ACC allows the crayfish to regenerate its exoskeleton (one-third of its body mass) within merely 3 days – a process that takes for other crustaceans about one month. Amorphical has demonstrated that ACC’s solubility, fractional absorption, bioavailability, and bioactivity are far superior compared to other calcium products, including products from the world’s leading companies.

Cancer is the general name for a group of diseases involving uncontrolled growth of cells, which mutate to form a malignant tumor capable of invading or spreading to other parts of the body. A cancerous tumor creates a new system of blood supply in the tumor area and has an ability for accelerated growth while evading attacks by the body’s immune system.

Amorphical’s scientists have been researching ACC’s usage as a potential anti-inflammatory and anticancer therapy. Following a series of experimental observations, they began to study ACC’s ability to successfully treat cancer due to its ability to modulate pH levels in acidic environments. These environments allow cancer cells to flourish and spread. In multiple preclinical studies conducted by Amorphical, ACC activity was repeatedly found to be directly associated with anticancer activity by neutralizing the acidity.

Below is a summary of the preclinical studies performed by Amorphical and the influence of ACC on cancer:

1. Cancer Cell Metabolism: One of the hallmark characteristics of cancer is shifting of the cellular metabolic pathway (processing glucose into energy) from oxidative phosphorylation to “aerobic” glycolysis. This shift simultaneously generates lactate and hydrogen ions (protons), even when there are sufficient oxygen levels, thus making the environment more acidic. A study performed with murine breast cancer cells showed that culturing in the presence of ACC suppressed the lactate metabolic route and increased the rate of the favorable oxidative phosphorylation pathway. This change did not occur in the presence of other calcium sources [crystalline calcium carbonate (CCC) or dissolved calcium chloride (CaCl₂)].
2. Differential gene expressions indicating strengthening the immune system and inhibiting cancer activity: The addition of ACC to various human cancer cell cultures was found to up- or downregulate multiple gene expressions in a way promoting  an anticarcinogenic phenotype. This phenotype is associated with reduced proliferation rates and an enhanced immune-system ability to fight cancer cells. Various influences of this sort were found for the following human cell lines: acute myeloid leukemia, prostate, lung, breast (two lines: (1) triple negative and (2) hormone positive cells), colorectal cancer, and cervical cancer cells.

3. Increased survival and reduction of tumor growth rate: In preclinical studies of bone metastases model of breast cancer cells animals treated with ACC had higher survival rates compared to control group animals.
Other studies done with a subcutaneous model of lung cancer in mice (Lewis Lung Carcinoma) revealed that tumors’ growth rates decreased significantly compared to the control group. In a xenograft study in which human lung cancer cells were injected into nude mice (mice with a compromised immune system), tumors’ growth rates of the ACC-treated mice were significantly lower relative to the control animals.

4. Reduction of the enzymatic activity of Cathepsin B:

Cathepsin B is a cysteine protease, an enzyme that breaks down proteins. Its high levels are found in malignant tumors. Cathepsin B is active only under acidic environments, and high levels of Cathepsin B are associated with tumor advancement, metastases creation, and development of associated inflammations.

Cathepsin B activity was assessed in mice with subcutaneous Lewis lung carcinoma (in tandem with the reduced tumor’s growth rates) that were treated with ACC, in comparison to control mice. The results exhibited a significant reduction of Cathepsin B activity for the ACC-treated mice groups, compared to the control group.

Amorphical Strives to Revolutionize Cancer Treatment

Our preclinical studies have demonstrated ACC’s ability to inhibit tumor growth, most likely via its ability to modulate the relatively low pH in tumor’s microenvironment.

In summary, the combined studies suggest that ACC:

1. Modulates acidity in inflammatory environment;

2. Improves/enhances immune response against the tumors and malignant cells;

3. Reduces the activity of Cathepsins (especially Cathepsin B, which helps tumors’ metastasis);

4. May slow down and alter the evolution of new blood vessels, hence decreasing nutrition to the tumor cells;

5. Changes cancer cells’ metabolism towards oxidative phosphorylation; and

6. Affects the cancer cells’ genetic expressions in modes that suppress the malignant activities and the resistance to the immune system of the body.

Amorphical’s initial clinical trials in patients with various types of terminal cancer, who had exhausted other regulated treatment options, have also indicated that ACC has anticancer potential, is a safe treatment even in relatively high doses, and does not exhibit the severe and traumatic side effects of standard cancer therapies.

Encouraged by these accumulated results, Amorphical is planning to conduct additional controlled clinical studies with larger groups of advanced cancer patients, for a more extensive examination of ACC’s potential in specific types of cancer. Successful studies will lead to novel treatments that revolutionizing the world of healthcare.