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New Cancer Drug Ready for Tests on Humans
June 3, 2015   
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A new drug for treating acute myeloid leukemia, lymphoma and myeloma, developed by researchers at Cracow-based biotechnology company Selvita, will soon be subjected to clinical trials. This marks the first time a Polish company specializing in research on innovative drugs for use in oncology will be submitting a drug for tests on humans.

Acute myeloid leukemia accounts for about 80 percent of all cases of acute leukemia in adults. Its incidence increases with age, most often affecting people over 50. Healthy blood cells are replaced by cancer cells. The number of red blood cells decreases, accompanied by anemia, weakness, shortness of breath, and fatigue; the patient gets tired quickly. A bleeding disorder develops as a result of platelet deficiency; patches appear on the skin and mucous membranes. These various forms of bleeding may pose a threat to the patient’s life. The lack of healthy white blood cells reduces the patient’s immunity, leading to infections, usually bacterial or fungal. Their course, especially at an advanced stage of leukemia, can be very severe. Poor blood circulation causes problems with vision as well as headaches.

Lymphoma most frequently causes the lymph nodes as well as the liver and the spleen to enlarge. These are tumors of varying malignancy. Those originating in the bone marrow are called leukemias. In turn, myelomas—or hematopoietic tumors—are usually diagnosed in patients suffering from frequent infections, mostly pneumonia, but also meningitis and inflammation of the urinary tract. Myeloma causes pain, usually around the spine and ribs as well as the spinal cord. Sometimes the patient has headaches that increase with movement. Patients with myeloma suffer from anemia and osteoporosis. Their bones break with minor injuries, bruises develop easily, and bleeding appears. Their kidneys lose their efficiency.

Many biotechnology companies are conducting research to develop effective drugs for these serious diseases. In Poland such projects are co-financed by institutions including the National Center for Research and Development (NCBR), which uses funds available under its Innomed program. One such grant has gone to Selvita, a biotechnology company based in the southern city of Cracow. The company’s researchers have for many years been looking for chemical compounds with anti-cancer properties. The most promising drug will soon undergo clinical trials, which is a key phase in the process of implementing medical innovations. The trials will show whether the new compound is effective therapeutically and safe to use for patients.

The KIND-1P “Introduction to clinical trials of new, selective anti-tumor kinase inhibitors” project has a budget of zl.20.1 million. Almost half of this amount, zl.9.4 million, comes from the NCBR. The rest is the company’s own contribution.

The project began in July 2014 and is scheduled to be completed in April 2017. The project manager is Dr. RenataWindak.

“For starters, we chose two compounds from two of our most advanced research projects,” says Windak. “The first compound is targeted against acute myeloid leukemia, the second against colorectal cancer. They are kinase inhibitors, or substances that can block certain signaling pathways within the cell. For example, they inhibit the activity of proteins responsible for cancer processes. The drugs we’re working on would thus inhibit the cancer process in patients with cancer.”

A compound potentially effective in the treatment of acute myeloid leukemia as well as non-Hodgkin lymphoma and multiple myeloma will be the first to undergo clinical trials. Existing drugs that target hematological cancers do not guarantee complete recovery. Very often patients with advanced hematological cancers can only expect to live a few months.

“Our compound is aimed at a group of patients who do not respond to chemotherapy,” says Windak.

Typically, in the first phase of clinical trials, a drug is administered to healthy volunteers. However, in the case of cancer drugs there is no such requirement and the drug can be tested on cancer patients straight away. However, toxicological tests will first be conducted on animals. The objective of the scientists is to develop a drug administered orally in the form of a pill, which is the most convenient form for patients.

Selvita was founded in 2007 and from the very beginning it conducted research to develop new drugs. In a pre-clinical phase new drugs require much smaller spending and the company has been able to develop a broad portfolio of research and development projects. Projects at later stages in terms of drug development, such as KIND-P1, cost much more. Selvita has raised funds to finance the project from a share issue on the main trading floor of the Warsaw Stock Exchange at the end of last year. It was previously listed on the exchange’s New Connect alternative market.

“Most of the research conducted by Polish pharmaceutical companies focuses on generic drugs, which means those for which a producer’s patent has already expired,” says Tomasz Nocuń, head of the finance department at Selvita. “Our company conducts research into innovative medicines that will be protected by original patents.”

The total cost of developing and bringing to market a new drug is beyond the reach of most Polish companies for the time being. It sometimes exceeds $1 billion including the costs of failed projects. That’s why Selvita is looking for a partner—a pharmaceutical company that will take over the development of the drug in the final stages. Pharmaceutical companies are interested in innovative medicines because such drugs ensure the highest earnings.

The new drug will be submitted to clinical trials with the aim of gaining approval for it to be used not only in Poland but worldwide.

“If our assumptions are confirmed, patients will be treated with a better drug than those currently in use. This is indicated by the results of its efficacy compared with that of currently available chemotherapeutic agents, conducted in tests on animals using human cancer models,” says Windak.

These results now need to be confirmed in clinical trials on humans. This, however, will take at least five years.

Karolina Olszewska
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