Research & Innovation

Myelo001 – Radiation Medical Countermeasures

Acute Radiation Syndrome (ARS), also known as radiation toxicity or radiation sickness, is an acute illness that presents after exposure to high levels of radiation, caused by a nuclear accident or attack. It can lead to severe health consequences, including death.

Myelo001 is currently investigated in non-clinical studies as a prophylactic and therapeutic treatment for acute radiation syndrome. Data published in blood showed that Myelo001 treatment leads to a significant reduction in mortality in an ARS animal model. Comprehensive chronic toxicology and safety studies, as well as clinical studies, have confirmed an excellent safety profile of Myelo001.

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Myelo001 for the treatment of Acute Radiation Syndrome (ARS).

Myelo001 – Cancer Supportive Care

One of the most common side effects of conventional chemotherapy is chemotherapy-induced myelosuppression (CIM), resulting in a reduction of red blood cells, white blood cells and platelets.

Radiation-induced myelosuppression (RIM) and radiation-induced neutropenia, lymphocytopenia and thrombocytopenia is a side effect of anticancer radiotherapy or radionuclides that can cause treatment interruptions and increase the risk of infections and bleeding. Unscheduled interruptions in radiotherapy have been associated with a reduced probability of local tumor control.

Radionuclides are used in radiation therapy to treat various types of cancer by delivering targeted doses of radiation to the tumor. These radioactive substances emit ionizing radiation, which damages the DNA of cancer cells and inhibits their ability to divide and grow.

Myelo001 is currently investigated in non-clinical and clinical studies as a prophylactic and therapeutic treatment for chemotherapy and radiation-induced myelosuppression.

Myelo001

myelo001 is a small molecule that is effective on the hematogenesis. Its oral application is being investigated as a treatment for chemotherapy-induced myelosuppression (CIM), radiation-induced myelosuppression (RIM), as well as acute radiation syndrome (ARS).

myelo001 was found to induce the differentiation of immature myeloid precursors. The effect of myelo001 is determined by both the protection of immature granulocytic cells in their early stage after cytostatic treatment and/or radiation, as well as a more active maturation of neutrophils.

myelo001 has reached a clinical stage in Europe with an efficacy and safety phase IIa study in chemotherapy-induced neutropenia.

myelo001 is currently investigated in non-clinical studies as a prophylactic and therapeutic treatment for acute radiation syndrome and radiation-induced myelosuppression.

Acute Radiation Syndrome and Radiation-induced Myelosuppression

Acute Radiation Syndrome (ARS), also known as radiation toxicity or radiation sickness, is an acute illness that presents after exposure to high levels of radiation, caused by a nuclear accident or attack. It can lead to severe health consequences, including death.

Radiation-induced myelosuppression (RIM) and radiation-induced neutropenia, lymphopenia and thrombocytopenia are adverse effects of anticancer radiotherapy that can cause treatment interruptions and increase the risk of infections and bleeding. Unscheduled interruptions in radiotherapy have been associated with a reduced probability of local tumor control.

Preclinical and clinical studies have shown that orally applied Myelo001 is effective in reducing hematopoietic symptoms caused by radiation overexposure or radio-chemotherapy. The effect of Myelo001 was observed for several distinct hematopoietic cell lineages including neutrophils, lymphocytes, and thrombocytes. Comprehensive chronic toxicology and safety studies, as well as clinical studies, have confirmed an excellent safety profile of Myelo001.

Myelo001 is currently being investigated in non-clinical studies as a prophylactic and therapeutic treatment for acute radiation syndrome. Data published in blood showed that Myelo001 treatment leads to a significant reduction in mortality in an ARS animal model.

The US Food and Drug Administration (FDA) and European Medical Agency (EMA) has granted Orphan Drug Designation to Myelo001 for the treatment of Acute Radiation Syndrome (ARS).

Chemotherapy-induced Myelosuppression

Conventional chemotherapeutic agents for anticancer treatment typically target rapidly proliferating cells and do not discriminate between tumor cells and healthy cells.

One of the most common side effects of conventional chemotherapy is chemotherapy-induced myelosuppression, resulting in a reduction of red blood cells (erythrocytes), white blood cells (leukocytes) and platelets (thrombocytes).

A reduced level of neutrophils (a type of leukocyte) is called neutropenia. It can leave a patient vulnerable to infection and to developing febrile neutropenia (FN), a condition that can be fatal and requires hospital admission.

Chemotherapy-induced neutropenia (CIN), the most serious hematologic toxicity, is associated with the risk of life-threatening infections as well as chemotherapy dose reductions and delays that may compromise treatment outcomes.

About 2.4 million chemotherapy cycles with a high to medium risk for IN are given each year. The global market for therapies to prevent CINhas a volume of more than USD 5 billion.

A reduction of platelets caused by chemotherapy is called chemotherapy-induced thrombocytopenia (CIT). It is a serious condition that can increase the risk of bleeding and cause chemotherapy dose reductions and treatment delays. Therapeutic options for CIT are even more limited than for IN, and CIT remains a significant clinical problem with a high unmet medical need.