Biotech Values

[pcrutch]

Re GERN

Pretty obvious. President and CEO of Moffitt didn't have a hard time spotting this.

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I asked two top experts in the field, Gary Gilliland, the former head of cancer research at Merck and the Vice President for Precision Medicine at Penn Medicine, and Alan List, the President and CEO of Moffit Cancer Center, for their thoughts on the data.

“It’s very interesting data but it’s very early, they have small numbers of patients with modest follow up,” says Gilliland. “I hate the hype that comes out around this because these patients are so desperate for treatments.”

In the exciting column: Four of 18 patients had blood test results consistent with a complete remission of disease, and one more with a partial remission and three with clinical improvement.

Gilliland says he’d want to know more about how sick they were at the beginning of the study – healthier patients are more likely to look like they’ve gone into remission based on a blood test. Myelofibrosis can be spotty, he says, so it’s useful to have long-term biopsies to make sure the bone marrow is improving. “Three months is different from two years.”

List notes that a blood test result is not enough to judge a complete remission. “These are not true CRs,” he says. But he’s encouraged by the fact that there was reversal of fibrosis, the bone marrow scarring, in the four patients whose blood tests showed signs of the cancer disappearing. “At least it’s evidence of activity,” he says. “The JAK inhibitors have no effect on fibrosis at all.”

But List does see a “major problem” for the Geron drug. Even for high-risk myelofibrosis patients, the condition is chronic. Imetelstat is likely to be given intravenously once a week for three weeks, followed by once every three weeks. With that dosing schedule, it’s going to be very difficult to get patients to stick to the regimen. “If you can get to a more extended schedule it makes a lot more sense,” List says.

http://www.forbes.com/sites/matthewherper/2013/11/07/independent-researchers-hopeful-but-cautious-about-geron-drug/?partner=yahootix