{"id":73938,"date":"2019-11-04T17:00:29","date_gmt":"2019-11-04T15:00:29","guid":{"rendered":"http:\/\/www.reunion68.se\/?p=73938"},"modified":"2019-10-27T09:32:34","modified_gmt":"2019-10-27T07:32:34","slug":"20-00-44","status":"publish","type":"post","link":"https:\/\/www.reunion68.se\/?p=73938","title":{"rendered":"New treatment offers hope for multiple myeloma and lymphoma"},"content":{"rendered":"
\"\"<\/a>New treatment offers hope for multiple myeloma and lymphoma<\/a><\/strong><\/span><\/h5>\n

Brian Blum<\/strong><\/span><\/p>\n

\n

Karyopharm of Israel and Massachusetts gets FDA approval for XPOVIO, the first drug aimed to help natural tumor-suppressing proteins do their job.<\/strong><\/p>\n

The Karyopharm Therapeutics team celebrating its listing on NASDAQ, November 2018. Photo: courtesy<\/em><\/span><\/p>\n

Cancer is a devious adversary. It figures out all kinds of ways to hide from the body\u2019s detection systems and grow unchecked until it\u2019s too late to stop them.<\/span><\/p>\n

One of cancer\u2019s most cunning methods of evading the immune system is to increase the frequency of a kind of cellular \u201ctrain\u201d \u2013 a protein called XPO1 \u2013 that makes regular back-and-forth trips in and out of the nucleus of a cell. The XPO1 protein\u2019s job is to shuttle other proteins to the right stops on the line.<\/span><\/p>\n

One passenger on the XPO1 shuttle is a tumor-suppressing protein. Its job is to conduct regular \u201caudits\u201d of a cell to ensure the DNA is not damaged. If it is, the protein instructs the cell to enter\u201cprogrammed cell death,\u201d whereby the cell essentially commits suicide.<\/span><\/p>\n

Cancer cells, by their very nature, have damaged DNA \u2013 that\u2019s what causes them to divide uncontrollably, creating tumors. In a healthy immune system, the tumor-suppressor proteins would catch the DNA mistakes in the nucleus and stop the cells from proliferating.<\/span><\/p>\n

But cancer outwits the tumor-suppressing proteins by increasing XPO1 activity. More frequent trains take the suppressor proteins out of the nucleus of the cell \u2013 where they should be stopping the cancer \u2013 and deposit them far away.<\/span><\/p>\n

\u201cThey can\u2019t do their job because they\u2019re geographically removed from where they\u2019re supposed to be,\u201d says Sharon Shacham, CEO of Karyopharm Therapeutics, an Israel- and Massachusetts-based company that has developed a new drug that inhibits XPO1 activity in a cell. \u201cWe stop the train from taking the passengers.\u201d<\/span><\/p>\n

When there\u2019s nothing left to try<\/span><\/p>\n

Karyopharm recently was awarded FDA approval for XPOVIO, the first drug to slow down the XPO1 train so that the body\u2019s natural tumor-suppressing proteins can do their job.<\/span><\/p>\n

XPOVIO (generic name Selinexor) has been approved for multiple myeloma patients who have relapsed and were resistant to at least four prior therapies.<\/span><\/p>\n

XPOVIO for multiple myeloma was approved according to the FDA\u2019s fast-track designation, which grants a quicker time to market for drugs addressing rare diseases or those for which there is no cure.<\/span><\/p>\n

Multiple myeloma, the second most common type of blood cancer after non-Hodgkin\u2019s lymphoma, can be slowed by medication \u2013 often going into remission for years \u2013 but ultimately it always returns and progresses. When a patient has gone through all of the available options, there\u2019s nothing left to try. Enter XPOVIO.<\/span><\/p>\n

Because of its dire prognosis, multiple myeloma was the starting point for XPOVIO, but it\u2019s far from the end game.<\/span><\/p>\n

\u201cMost cancer cells have XPO1 overexpressed,\u201d Shacham tells ISRAEL21c. \u201cWe are planning to submit XPOVIO for approval with lymphoma next.\u201d<\/span><\/p>\n

If the results are positive, Karyopharm will move on to test XPOVIO with various types of sarcoma, earlier lines of myeloma, uterine cancer and brain cancer, Shacham says.<\/span><\/p>\n

Shacham is quick to point out that XPOVIO can\u2019t be declared a cure for multiple myeloma \u2013 at least not yet. It simply hasn\u2019t been around long enough, although patients \u201care seeing long-term benefits,\u201d she says.<\/span><\/p>\n

Nor is XPOVIO side-effect free. Nausea, vomiting, fatigue, low white blood count and anorexia are all common. \u201cIt\u2019s outlined in the label,\u201d she points out. \u201cBut with supportive care, patients can stay on XPOVIO.\u201d<\/span><\/p>\n

The drug doesn\u2019t come cheap: it costs $22,000 for a four-week supply, although patients approved for the drug by their health-insurance plan won\u2019t need to pay the full amount.<\/span><\/p>\n

Overall response rate of 25.3%<\/span><\/p>\n

Karyopharm has been running at a marathon pace against cancer over the past decade.<\/span><\/p>\n

More than 3,000 people have gone through clinical trials in 20 company-sponsored studies and another 50 studies run by individual investigators looking at the drug either as a single agent or in combination with other medicines including dexamethasone, a steroid commonly used as part of chemotherapy.<\/span><\/p>\n

For FDA approval of XPOVIO for multiple myeloma, 83 patients were tested with the drug plus dexamethasone. The median time to first response was four weeks with a median duration of response of 3.8 months.<\/span><\/p>\n

The overall response rate at the end of the study was 25.3%, which \u201cis clinically meaningful and a validated surrogate marker for clinical benefit in our patients with advanced refractory disease,\u201d said Dr. Sundar Jagannath, director of the Multiple Myeloma Program at the Tisch Cancer Institute at Mount Sinai School of Medicine in New York.<\/span><\/p>\n

Shacham received her PhD in computational biophysics from Tel Aviv University in 2000. She founded biotech firm Predix upon graduation; Predix merged with Epix Pharmaceuticals in 2003.<\/span><\/p>\n

Shacham launched Karyopharm 10 years ago with headquarters in Newton, Mass., and a subsidiary in Israel. The company raised Series A funding of $20 million in 2010 and began testing XPOVIO in 2012. Karyopharm now employs more than 300 people and is listed on the NASDAQ stock exchange.<\/span><\/p>\n

Karyopharm Therapeutics cofounders, President and CSO Sharon Shacham and CEO Dr. Michael Kauffman, ringing the bell at the NASDAQ Stock Exchange. Photo: courtesy<\/em><\/span><\/p>\n

Shacham is particularly bullish on the company\u2019s Israeli operation.<\/span><\/p>\n

\u201cMost US-based companies will open an office in Europe,\u201d she tells ISRAEL21c. \u201cWe chose to move that to Israel instead \u2013 for several reasons. First, the quality of the people in Israel is outstanding. They are very well educated, collaborative and they love to tell us what\u2019s wrong. Israeli companies have a very open dialogue with the medical community in Israel, as well, which is key.\u201d<\/span><\/p>\n

In addition, Israeli business and work culture is \u201cmore similar to American culture than European culture,\u201d Shacham says.<\/span><\/p>\n

And a surprising third reason: \u201cBen-Gurion is an excellent airport.\u201d Not only does it run efficiently, she says, but it is easy to get to partner hospitals in Europe. \u201cFor central and eastern Europe, you have more low-cost flights out of Ben-Gurion than the typical airport in the European Union.\u201dIsrael is close in time zone to Europe and the seven-hour difference from the East Coast of the United States is workable.<\/span><\/p>\n

\u201cI really hope this model will be adopted by other biotech companies,\u201d Shacham says.<\/span><\/p>\n

Patients interested in joining a clinical trial of XPOVIO \u2013 in Israel or elsewhere \u2013 can find a full list of testing sites at Karyopharm.<\/span><\/p>\n

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New treatment offers hope for multiple myeloma and lymphoma Brian Blum Karyopharm of Israel and Massachusetts gets FDA approval for XPOVIO, the first drug aimed to help natural tumor-suppressing proteins do their job. The Karyopharm Therapeutics team celebrating its listing on NASDAQ, November 2018. Photo: courtesy Cancer is a devious adversary. It figures out all […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[26,24],"_links":{"self":[{"href":"https:\/\/www.reunion68.se\/index.php?rest_route=\/wp\/v2\/posts\/73938"}],"collection":[{"href":"https:\/\/www.reunion68.se\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.reunion68.se\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.reunion68.se\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.reunion68.se\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=73938"}],"version-history":[{"count":7,"href":"https:\/\/www.reunion68.se\/index.php?rest_route=\/wp\/v2\/posts\/73938\/revisions"}],"predecessor-version":[{"id":74086,"href":"https:\/\/www.reunion68.se\/index.php?rest_route=\/wp\/v2\/posts\/73938\/revisions\/74086"}],"wp:attachment":[{"href":"https:\/\/www.reunion68.se\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=73938"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.reunion68.se\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=73938"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.reunion68.se\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=73938"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}