Karyopharm Starts Phase I Study - Analyst Blog

Karyopharm Therapeutics Inc. KPTI commenced a phase I study which will evaluate selinexor in pediatric patients with relapsed or refractory acute lymphoblastic leukemia ALL or acute myeloblastic leukemia (AML).

This study will determine the oral dosing, toxicity and preliminary clinical activity of selinexor in relapsed or refractory pediatric leukemia patients. The study is led by Dana-Farber/Boston Children's Cancer and Blood Disorders Center.

Karyopharm's lead candidate, selinexor, is currently in three open-label phase I studies. The first study will evaluate selinexor in patients with heavily pretreated relapsed and/or refractory hematological malignancies, while the second will evaluate selinexor in patients with heavily pretreated relapsed and/or refractory solid tumor malignancies. The third is a food effect study, which will evaluate selinexor in patients with metastatic, locally advanced or locally recurrent soft tissue or bone sarcomas.

Karyopharm has also started phase II studies to evaluate selinexor in relapsed glioblastoma multiforme and in ovarian, cervical and uterine carcinomas. In 2014, Karyopharm will also initiate phase II studies in squamous head, neck or lung cancer and hormone and chemotherapy refractory metastatic prostate cancer.

Recently, Karyopharm started a phase I study on selinexor in combination with Dacogen in relapsed or refractory AML patients and also in patients (age ≥60 years) with newly diagnosed AML.

We expect investor focus to remain on updates pertaining to selinexor, it being the lead product at Karyopharm.

Karyopharm carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector include Salix Pharmaceuticals Ltd. SLXP, Impax Laboratories Inc. IPXL and Enanta Pharmaceuticals, Inc. ENTA. Salix Pharma and Enanta carry a Zacks Rank #1 (Strong Buy) while Impax Labs holds a Zacks Rank #2 (Buy).