Pluristem Therapeutics, Inc. (PSTI) recently announced that its Korean partner, Cha Bio&Diostech, has filed its first investigational new drug (IND) application for Pluristem's PLacental eXpanded (PLX) cells with the Korean Food and Drug Administration (:KFDA).
Cha Bio&Diostech is seeking the KFDA’s permission to initiate a phase II trial for the use of PLX-PAD in the treatment of intermittent claudication (:IC).
We remind investors that Pluristem inked an exclusive out-license and strategic partnership agreement with Cha Bio&Diostech in Jun 2013 whereby Cha Bio&Diostech can use Pluristem's PLX cells for treating peripheral artery disease (:PAD) in South Korea.
The deal is specifically for two indications – critical limb ischemia (CLI) and IC.
We note that Pluristem develops placenta-based cell therapies. As per the agreement, Cha Bio&Diostech will be responsible for conducting and sponsoring clinical trials on PLX-PAD for the potential treatment of patients suffering from CLI and IC in South Korea. The studies will be conducted under the supervision of the KFDA.
However, Pluristem will retain rights to its proprietary manufacturing technology as well as cell-related intellectual property. The company will also have rights to use the data generated from the studies conducted by Cha Bio&Diostech, to advance its PLX candidates outside South Korea.
Pluristem and Cha Bio&Diostech will form a joint venture after receiving the first regulatory approval for a PLX product in South Korea. The joint venture will market PLX cell products there.
Pluristem develops placenta-based cell therapies in collaboration with companies like United Therapeutics (UTHR) or through research and clinical institutions.
Meanwhile, other companies like Celgene Cellular Therapeutics, a wholly-owned subsidiary of Celgene Corporation (CELG) is conducting research on stem cells derived from the human placenta as well as from the umbilical cord for the treatment of different diseases.
Pluristem currently carries a Zacks Rank #3 (Hold). The company suffered a setback last month when the US Food and Drug Administration (:FDA) placed a clinical hold on a phase II IC study following a serious allergic reaction in one of the patients who required subsequent hospitalization.
The patient was discharged the next day after the symptoms were managed.
Right now, Array BioPharma (ARRY) looks attractive with a Zacks Rank #2 (Buy).
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