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Geron (GERN) Under Pressure as Clinical Trial Changes Causes Delays



8/1/2017 12:20:14 PM

Geron Under Pressure as Clinical Trial Changes Causes Delays August 2, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Menlo Park, Calif. – Geron Corporation (GERN) stock took a big hit upon news of changes in two of its clinical trials with Janssen Oncology, a Johnson & Johnson (JNJ) company. The trials aren’t in jeopardy, but they will require significant patience on the part of investors, which seems to be the cause of the stock drop.


Geron announced updates of its two clinical trials, IMerge and IMbark of its telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively.

IMerge is being expanded to enroll more patients in a refined MDS population. This will help to confirm the clinical benefit and safety that was observed previously. The IMbark trial remains unchanged, but the company indicates that protocol-specified primary analysis, once completed, triggers a future Continuation Decision by Janssen. As a result, it might be delayed to as late as the third quarter of 2018.

The changes were initiated by Janssen. In the case of the IMbark trial, this underlines that Janssen has not committed to a Phase II trial of the drug in myelofibrosis. This isn’t really new, but appears to emphasize that Janssen could decide to abandon the trial.

Maxx Chatsko, writing for The Motley Fool, says, “The news has put investors on edge because they’re worried that Geron Corporation and Janssen don’t share the same level of confidence in the drug candidate. For instance, the changes to the IMerge trial will ‘enroll additional patients in a refined MDS population to confirm the clinical benefit and safety observed from current results.’”

Which is another way of saying they’re narrowing the patient population. Possibly. Chatsko writes, “While that could be homing in on more specific patients that are more likely to benefit, failing to ‘confirm the clinical benefit and safety observed’ thus far could mean the end of the study. Given that imtetelstat is the company’s only drug candidate, such an outcome could be an existential threat to Geron Corporation.”
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The bottom line on the changes appears to be that the companies need to gather more data. Investors have shown their impatience by tanking company stock.

Geron stock is currently trading for $2.19. On July 27, shares traded for $2.84. The year high was on May 24, when shares traded for $3.07.

A writer with Seeking Alpha going under the pseudonym Out of Ignorance, writes, “Last night’s press conference from Geron, followed by this morning’s conference call, provided new data points to consider in the lingering imetelstat saga. The conclusion I drew from the carefully scripted presentations was that all’s well for those who have plenty of time and are willing to wait patiently while this multipart drama unfolds on its own time schedule.”

Geron and Janssen inked their license and collaboration deal for imetelstat in November 2014.

Chatsko concludes, “When the oddly worded language about changes to IMerge is combined with the fact that Janssen is dragging its feet on deciding whether or not to push ahead with the IMbark trial, it’s easy to see why Mr. Market is losing faith in Geron Corporation stock on Tuesday. It’s still too early to get carried away with interpretations, but the company hasn’t exactly accomplished anything of note in its nearly 30-year history.”


Read at BioSpace.com


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