A clinical trial in an area of medicine that was stagnant for more than 50 years was able to show progress for acute myeloid leukemia patients, adding around three months to their life spans.
Acute myeloid leukemia is the most common type of acute leukemia in adults, a cancer of the white blood cells.
Acute myeloid leukemia is generally a disease of older people and is uncommon before the age of 45, according to The American Cancer Society. The society estimates there will be about 19,950 new cases of acute myeloid leukemia this year.
When patients develop this type of cancer, the only viable option is a bone marrow transplant.
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In order to receive a transplant, patients have to qualify, and that means the patient’s leukemia cells have to decrease to a low level. The current 50-year-old chemotherapy treatments to help decrease the amount of leukemic cells can be problematic. For one, they are cardiotoxic and, if taken in high doses, have the potential to stop the heart.
The cancer cells eventually begin to recognize the chemotherapy as a poison, said Walter Klemp, chairman and CEO of Moleculin Biotech, based in Houston. They will then work to protect themselves before the treatment can kill them, he said.
“Cancerous cells have co-opted defense mechanisms to protect cells from chemotherapy,” Klemp said.
Every unsuccessful treatment patients endure diminishes their ability to tolerate the chemotherapy.
The new treatment Moleculin has developed, currently under clinical trial, is called annamycin, and is special for two reasons, Klemp said.
Annamycin is a game-changer, Klemp said, because it is able to get into cancerous cells without being detected. In addition, annamycin is special is because it’s not cardiotoxic.
Through the clinical trial, 30 percent of patients reacted well enough toward annamycin and were able to qualify for bone marrow transplants, even after failing, on average, five chemotherapy treatments.
After administering annamycin over the a period of five days, patients’ life spans increased from six months to more than nine months.
“We demonstrated an ability to generate a response in people who were previously untreatable,” Klemp said.
Moleculin is on the second phase of clinical trials, on the journey to prove there is significant benefit for patients through the long-awaited breakthrough for myeloid leukemia patients.
The process of gaining approval from the FDA is expected to last eight to nine months, Klemp said, adding that he thinks they have a good chance at receiving accelerated approval.