New Drug for Acute Myeloid Leukemia

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PHOENIX, Ariz. (Ivanhoe Newswire) — Most patients diagnosed with acute myeloid leukemia, or AML face weeks of intense, brutal chemotherapy and maybe a stem cell transplant. Even then, the American Cancer Society says only about 27 percent will live another five years. Now a Salt Lake City company is testing a targeted therapy that is showing promising early results.

Lila Javan was 39 when she was diagnosed with AML the first time.

“Thirty six hours later, I was in UCLA hospital on IV chemo 24/7. And I didn’t leave that hospital for two months,” Javan told Ivanhoe.

After months of chemo and a stem cell transplant, Lila was back home with her cat, O’Malley. But four years later, the cancer came back.

Javan continued, “There were times when I thought I wasn’t going to make it.”

David Bearss’ company, Tolero Pharmaceuticals, is testing a drug called alvocidib, which targets a protein called CDK9.

“It affects a particular protein that those AML cells like to express. It’s a survival protein; it’s a protein that helps them not die,” David Bearss, PhD, of Tolero Pharmaceuticals told Ivanhoe. (Read Full Interview)

CDK9 allows cancer cells to ignore signals to die. Alvocidib lets the chemotherapy in to kill the cancer. Trials show it is improving remission rates. Bearss says 25 percent of AML patients have something in them that allows alvocidib to work. They’re tested for that before getting into the trial.

“It asks the question, what is the mechanism the cell is using to live, and if it’s using this particular protein, then we know the drug will work,” Bearss stated.

Lila’s in remission again, but she’s still excited about alvocidib potential.

Javan explained, “It’s amazing. You know, like I said, it would be a total game changer and so many people would be helped.”

The alvocidib trial has enrolled 400 patients and is being run at nine sites in the US and Canada. It’s open only to people who have positive responses to the test. But, Tolero expects to run a bigger randomized study soon and will have a better idea of how long alvocidib can extend people’s lives.

Contributors to this news report include: Wendy Chioji, Field Producer; Bruce Maniscalco, Videographer; Cyndy McGrath, Supervising Producer; Gabriella Battistiol, Assistant Producer; Roque Correa, Editor.

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MEDICAL BREAKTHROUGHS

RESEARCH SUMMARY

TOPIC: NEW DRUG FOR ACUTE MYELOID LEUKEMIA

REPORT:          MB #4318

BACKGROUND: Acute myelogenous leukemia (AML) is a type of blood cancer. It’s called myelogenous because it affects a group of white blood cells called the myeloid cells. AML occurs as a result of damage to the DNA of developing cells in the bone marrow, which causes the blood cell production to go wrong. The bone marrow produces unhealthy cells that develop into leukemic white blood cells called myeloblasts. In most cases, it is not clear what causes the DNA mutation that leads to leukemia. Factors that may increase an individual’s risk of acute myelogenous leukemia include increasing age, sex, previous treatment, exposure to radiation, dangerous chemical exposure, smoking, genetic disorders, and other blood disorders. Nevertheless, there are people with no known risk factor for the disease, and there are people who have risk factors and never develop cancer.

(Source: http://www.mayoclinic.org/diseases-conditions/acute-myelogenous-leukemia/basics/definition/con-20043431)

SYMPTOMS/TREATMENT: General signs and symptoms of acute myelogenous leukemia may mimic those of the flu or other common diseases, but it varies based on the type of blood cell affected. Signs and symptoms of acute myelogenous leukemia are fever, bone pain, lethargy and fatigue, pale skin, frequent infections, and easy bruising or unusual bleeding. There is no cure for AML, but there are treatments that will allow the patient to live comfortably. There are two phases in the treatment: remission induction therapy and consolidation therapy. The purpose of the remission induction therapy is to kill the leukemia cells in the blood and bone marrow. The consolidation therapy phase focuses on destroying the remaining leukemia cells. Treatments used in these stages include chemotherapy, stem cell transplant, clinical trials, and other forms of therapy.

(Source: http://www.mayoclinic.org/diseases-conditions/acute-myelogenous-leukemia/basics/treatment/con-20043431)

NEW TECHNOLOGY: Researchers are testing a drug called Alvocidib that targets a protein called CDK-9 which allow cancer cells to ignore signals to die. Alvocidib lets the chemotherapy in to kill the cancer cells. The Alvocidib Phase II clinical trials in AML enrolled more than 400 patients. The trial demonstrates that there is significant activity when alvocidib is combined with a dosing treatment that includes the standard of care agents cytarabine and mitoxantrone (ACM). The study demonstrated that ACM showed an improvement in the complete remission (CR) rate of high-risk AML compared to the standard-of-care.

(Source: Dave Bears, Ph.D. Tolero Pharmaceuticals CEO and http://www.toleropharma.com/alvocidib.html)

TRIAL SITES INCLUDE: Northside Hospital, Atlanta; University of Iowa, Iowa City; University of Kansas, Westwood, Kansas; Ochsner Clinic, New Orleans; Johns Hopkins Sidney Kimmel; Cancer Center, Baltimore; Columbia U. Medical Center, NYC; University of North Carolina, Chapel Hill; Baylor Cancer Center, Dallas; Princess Margaret Cancer Center, Toronto.

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:

David Bearss

dbearss@toleropharma.com

Scott Stachowiak

scott.stachowiak@russopartnersllc.com

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com

Doctor Q and A

Read the entire Doctor Q&A for David Bearss

Read the entire Q&A