FDA Demands Karyopharm Stop Enrollment of All Selinexor Trials

FDA Demands Karyopharm Stop Enrollment of All Selinexor Trials March 13, 2017
By Alex Keown, BioSpace.com Breaking News Staff

NEWTON, Mass. – Shares of Karyopharm Therapeutics are on the upswing this morning after plummeting on Friday following news the U.S. Food and Drug Administration placed a partial clinical hold on trials for selinexor (KPT-330).

According to a statement from Karyopharm, the FDA placed the trial on hold due to “incomplete information in the existing version of the investigator's brochure (IB), including an incomplete list of serious adverse events (SAEs) associated with selinexor.” Karyopharm said it amended the IB and updated the informed consent documents. The company submitted the updated documents to the FDA. Karyopharm noted the partial clinical hold is not the result of any patient death or any new information regarding the safety profile of selinexor. To date, more than 1,900 patients have been treated with selinexor in clinical trials across a variety of hematological and solid tumor malignancies, Karyopharm said in its statement. The company said it anticipates the FDA to notify it within 30 days is the information submitted by the company is satisfactorily enough to lift the partial hold.

“Karyopharm is working diligently with the FDA to seek the release of the partial clinical hold and resume enrollment in its selinexor clinical trials as expeditiously as possible. Karyopharm believes that its previously disclosed enrollment rates and timelines for its ongoing trials will remain materially unchanged,” the company said in a statement. John Carroll from Endpoints said a company spokesperson told him they received the FDA’s verdict last week, but did not provide information on how many days prior to the announcement.

Writing in Endpoints, Carroll questioned the timing of Karyopharm’s announcement. He said a company claiming it has submitted its responses to the FDA at the same time it’s making a public announcement about the partial clinical hold raises questions about how long the company has known about the hold.

Because of the FDA action, Karyopharm said no new patients may be enrolled in the trial until the partial clinical hold is lifted. After the company made its announcement Friday, shares dropped from a high of $12.11 to a low of $10.21. Shares are currently trading at $10.69. The announcement of the partial clinical hold comes days before the company is expected to provide its year-end 2016 financial results.

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound, is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone and backbone therapies, in diffuse large B-cell lymphoma and liposarcoma. Karyopharm plans to initiate a pivotal randomized Phase III study of selinexor in combination with bortezomib and low-dose dexamethasone in patients with multiple myeloma in early 2017.

While selinexor is being investigated in multiple trials, last week the company disclosed that selinexor as a monotherapy for acute myelogenous leukemia failed to meet primary endpoints in a Phase II trial.

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