In the first week of July, after a development process starting in 2009, the American Food and Drug Administration (FDA) approved sale of the first prescription medication developed by Karyopharm, XPOVIO TM. In addition to its contribution to myeloma leukemia patients, the medication heralds a new message to cancer patients of various types: It is the first medication successful in delaying the activity of the protein that accelerates proliferation of cancer cells in the patient's body.
The day after receiving FDA approval, Karyopharm's stocks, traded on NASDAQ, rose by 40%. Many physicians in the USA approached the company and requested a supply of the medication for their patients. Within six days of FDA approval, cancer patients throughout the USA started benefiting from this innovative treatment.
Research findings, based on Dr. Shacham's doctoral study that led to FDA approval, are unusual and inspirational. Approximately 40% of patients responded to the medication and their tumors shrank in size. Their life expectancy increased from 3 to 5 times due to this innovative treatment. Karyopharm has already reaped world wide praise; last week the prestigious, veteran New England Journal of Medicine published an article about the new medication and about the relevant associated research findings.
Multiple myeloma is the second most common type of leukemia. It originates in one abnormal plasma cell that undergoes change. It begins to proliferate uncontrollably in bone marrow. It is estimated that in Israel, there are between 400 and 500 new cases of multiple myeloma annually. The disease harms various body systems and may cause anemia, lytic spots in the bones, impairment of the kidneys, and a sharp increase in calcium levels.
Just recently, the FDA approved the marketing of Karyopharm's first prescription medication XPOVIO TM. The biggest challenge in the war on cancer, is understanding why the human body permits uncontrollable proliferation of cancerous cells, as opposed to the normal proliferation of healthy cells. Parallel to the attempt to crack this puzzle, scientists throughout the world are trying to find ways to delay the process of uncontrollable proliferation of cancerous cells. Karyopharm has been successful in attaining this revolutionary achievement by developing a mechanism that influences the 1-XPO protein that plays a critical role in the uncontrollable proliferation process.
The medication works by keeping the body's "regulating" proteins inside the cell nucleus, where they do their work and prevent the proliferation of cancerous cells.
Patients receive the medication in 20 mg tablets, taken orally. The initial dosage a patient receives is 80 mg (4 tablets) twice weekly, in treatment course of 28 days. The price of every course of treatment in the USA is $22,000. The medication has not yet been approved for use in Israel, but is administered as compassion-focused therapy.
To date, the medication has been successfully used by myeloma patients. Additionally, the medication is undergoing advanced clinical trials with various types of cancer patients, among them myeloma, lymphoma, sarcoma, uterine cancer and brain cancer.
Dr. Sharon Shacham said: "We believe that our activity at Karyopharm constitutes an important milestone in the war on cancer and are pleased to discover that its mechanism of activity covers many types of cancer."
Anat Haas Mizrahi, General Manager at Karyopharm, Israel, said: "We are continuing our activities to promote the development of XPOVIO for additional indications and promoting clinical trials also in Europe and in Israel. Most of the clinical trials are open to patients in Israel; naturally, we will continue to works towards receiving approval to market and sell OPDIVO in Israel as well."
Myeloma is more prevalent amongst people aged 60 and above, and somewhat more common amongst men. Less than 1% of those diagnosed are under the age of 35; most of the patients, 65%, are diagnosed after age 65. 33% of patients are above the age of 75.
Research conducted at Sheba Medical Center in 2014, shows that the incidence of disease is 61% lower amongst those of Mizrahi ethnic affiliation, as compared to descendants of immigrants from Europe; who are characterized by what is called an "Ashkenazi" mutation that, amongst other things, also constitutes an extra risk of being afflicted by breast and/or ovarian cancer.
Additional risk factors for myeloma include a high dose of ionizing radiation, agricultural pesticides, chemical materials such as diesel, infections stemming from viruses, weight gain and obesity, and consumption of processed meats, dairy products, and red meat.