By Kim Rahn
Staff Reporter
A new leukemia medicine developed by a Korean drug maker has passed through the first phase of clinical trials.
The drug, developed by Ilyang Pharmaceutical, is believed to be 30 times more effective than Gleevec, a popular anti-leukemia medicine. If successful, it is expected to change the landscape of the leukemia drug market.
A research team at Seoul St. Mary's Hospital's hematopoetic stem cell transplant center, led by professor Kim Dong-wook, administered the new medicine, named IY5511, to 22 chronic myeloid leukemia patients from July 2008 until June this year. The patients had previously shown tolerance or experienced side effects to existing drugs such as Gleevec and Sprycel. No virulence or side effects occurred, and the patients' blood condition showed improvement, the hospital said.
In previous tests on animals, the drug showed it was 30 times more effective than Gleevec, according to the research team.
To test safety and efficacy, the team administered doses of IY5511 from 100 milligrams to 1,000 milligrams per day, with the largest amount proving to be safe. Among the 22 patients, 16, or 73 percent, have exhibited no side effects and developed no other problems thus far.
``The efficacy of the new drug rises in proportion to the dose. Many of the patients also had their level of the Philadelphia chromosome, the cause of leukemia, reduced,'' Kim said.
The drug, however, showed differing levels of efficacy depending on the condition of the patient. Like existing drugs, it was more effective for those in the chronic phase and the accelerated phase, while being less effective for those in the blast phase.
Clinical trials are comprised of three phases. In the first, researchers examine dosage safety. In the second, they examine the drug's efficacy and in the third, the trial is expanded to more people before the drug products are launched.
The research team for IY5511 began the second phase Thursday. It will try administering 800 milligrams to 120 to 140 patients in the chronic and accelerated phases of the disease for six to 12 months. Six domestic hospitals and seven foreign ones ― in China, India and Thailand ― will join the trial.
``If the drug is proven to be effective for 25 percent of the patients, it can get approval for sale. As the results of the first phase trial were good, we expect approval for commercial use to be made in a year at the earliest,'' Kim said.
The new drug is likely to bring a huge change to the anti-leukemia medicine market, as patients here have had access to only imported drugs costing 70 to 100 billion won per year. There are about 2,300 chronic myeloid leukemia patients in Korea, with some 300 new patients being diagnosed every year.