Clinical Trial Hold Of Geron's Revolutionary Drug Imetelstat Will Be Temporary

Mar. 18, 2014 9:19 AM ETGeron Corporation (GERN)118 Comments
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Summary

  • The clinical hold does not currently affect the Mayo sponsored Myelofibrosis clinical trial.
  • EV patients had been on treatment for an average of 14 months, with the longest being 2.5 years without any progression of LFT abnormalities.
  • Current price provides risk tolerant investors a significant opportunity to double their investment in a short period of time.

Geron's (NASDAQ:GERN) Imetelstat hit a road block this past week when the FDA placed a clinical hold on two company sponsored clinical trials due to persistent low grade liver functionality test (LFT) abnormalities in patients remaining on drug in the Essential Thrombocythemia (ET) or Polycythemia Vera (PV) and Multiple Myeloma trials. The report of low grade LFT abnormalities in these patients is not new. As stated in the June 2013 press release:

At least one abnormal liver function test was observed in laboratory findings in all patients. The majority were Grade 1 elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST); two Grade 3 increases in ALT/AST were reversible on dose reduction. With longer dosing, Grade 1 increases in alkaline phosphatase were observed, associated with mostly Grade 1 to some Grade 2 unconjugated hyperbilirubinemia. LFT abnormalities do not appear to progressively worsen over time. No liver injury symptoms were reported and no patients discontinued study treatment due to enzyme elevations.

Importantly, as presented at the European Hematology Association Congress, these ET patients had been on treatment for an average of 14 months, with the longest being 2.5 years without any progression of LFT abnormalities. This is a very good sign. If chronic exposure to the drug resulted in severe liver cirrhosis, you would expect complications to progress over time. I expect we will see LFT levels be reduced to baseline after complete drug removal, just as the rare Grade 3 increases were decreased with dose reduction.

In the written notice received by Geron, the FDA detailed that there was a clinical hold due to lack of liver toxicity reversibility data and lack of adequate follow-up in patients who experienced hepatotoxicity. To remove the clinical hold, the FDA wants Geron to:

  • provide clinical follow-up information in patients who experienced liver function

This article was written by

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I am an individual investor who has been actively involved in the healthcare and biotechnology space for over 15 years. I hold a PhD in the biomedical sciences and have worked in both large pharmaceutical and small biotech companies. I make investments based on the fundamentals of a company and if I believe they have a superior technology or products compared to the competition. I'm an investor who believes patience pays off.

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