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New Acute Myeloid Leukemia Drug Gets FDA Fast Track Designation

The process by which a drug goes from clinical trials to being available to the general public is usually long and arduous. Constant tests and examinations over the course of several years are required to ensure that the health benefits are genuine and negative effects manageable. Many patients don’t have that long. Acute Myeloid Leukemia [...]

The process by which a drug goes from clinical trials to being available to the general public is usually long and arduous. Constant tests and examinations over the course of several years are required to ensure that the health benefits are genuine and negative effects manageable. Many patients don’t have that long.

Acute Myeloid Leukemia is a type of cancer that initially develops in the bone marrow, but more often than not moves into the blood, mutating white cells. Despite many treatment advancements, older patients don’t respond too well to the current therapy options, mainly chemotherapy. Cantex’s CX-01 is designed to help exactly this category of cases, people aged 60 and older.

The Fast Track Designation is a measure that the FDA can take in order to “expedite the review of drugs to treat serious conditions and fill an unmet medical need”. The idea is to bring these possibly lifesaving forms of medication to the patients quicker. Recommendations of this sort mean that the drug showed superior effectiveness, avoids serious adverse effects or considerably improves patient outcome.

Produced by Cantex, one of the leading biopharmaceutical companies focused on cancer treatment research, CX-01 is a polysaccharide acting as an anticoagulant heparin derivative. In a recent clinical trial, the drug displayed some impressive results when it produced “morphologic complete remission after 1 induction” in the majority of the trial participants. It seems that CX-01 can disrupt cytokine and signaling pathways making the cancer cells more sensitive. Additionally, it could neutralize platelet factor-4, thus stimulating bone marrow recovery.

While everything seems to point to a very successful and effective treatment option, it is important to mention that there are still many variables to tackle, the first of which is a larger sample size, as the initial trial only involved 12 cases.

Nevertheless, CX-01 showed encouraging response rates and will hopefully improve the lives of many cancer patients.

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