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Cellect Shares Rally After Lead Stem Cell Program Receives Clearance For Midstage Study

Shanthi Rexaline

The thinly traded nano-cap penny stock CELLECT BIOTECH/S ADR (NASDAQ: APOP) was soaring Monday.

What Happened

Israel-based Cellect, a developer of stem cell production technology, announced Monday that the Data and Safety Monitoring Board recommended dose escalation and the continuation of enrollment for the fourth and final dose cohort in the ongoing Phase 1/2 clinical study of ApoGraft.

ApoGraft is a platform or production technology designed to eliminate immune responses in any transplantation of foreign cells and tissues.

The determination from the DSMB comes after one-month data from the ninth patient enrolled in the mid-stage trial became available.

Cellect said that at one month after transplantation, the patient has shown complete engraftment and has not shown any procedure-related adverse effects.

"In Israel, the DSMB's recommendation to proceed to the final cohort of our ApoGraft study without modification furthers us towards meeting our goal of enrolling the final three patients by the end of this year, which reaffirms the positive safety data to date," Cellect CEO Dr. Shai Yarkoni said in a statement. 

What's  Next

Cellect said it now expects to complete patient recruitment by the end of 2019, with data from the trial due in the first half of 2020.

The primary endpoint of the trial is the evaluation of the overall incidence, frequency and severity of adverse events potentially related to ApoGraft at 180-days post-transplant, according to the company. 

In the U.S., Cellect is set to initiate its first trial following Washington State University's Scientific Review Committee approving its study with no comments.

Price Action 

Cellect shares were trading higher by 78.55% at 74 cents at the time of publication Monday. 

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