From Pat Cox's weekly alert.
Thought you might be interested.
"Galectin Therapeutics Phase 1 Safety Trial Shows Dramatic Effects in Liver Disease
First of all, you need to watch the entire presentation, which was given by Galectin Therapeutics CEO and CMO Dr. Peter Traber. Traber, as you know, is president emeritus and ex-CEO of Baylor College of Medicine. He was also senior vice president of clinical development and medical affairs and chief medical officer of GlaxoSmithKline.
This is the link for the PDF that is used in the presentation. Everything you need to know is there but it’s good to have Traber clarifying the charts. As of now, you can access the recorded presentation by clicking onthe link on the company’s main page.
The link is in the center “Highlights” section and is titled, “View Galectin Therapeutics’ webcast discussing first cohort results of Phase 1 clinical trial of GR-MD-02 in NASH.” Click on it, register, and stream the presentation. Years from now, you can tell your grandkids that you were watching when fibrosis, a condition that prematurely killed a huge percentage of the population, was made a minor and treatable problem.
If that weren’t enough, the company’s cancer trials are set to start at any time. By the time this alert shows up in your inbox, they may be under way. The scope of this platform, which blocks galectin-3s, is vast.
Just as I predicted that the data released in the presentation would be positive, I’m predicting that the cancer trials will also prove more than successful.
As Traber says several times in the presentation, the results in the first cohort of eight patients were better than he expected. I won’t go into great detail about them because the presentation covers the data so completely, but I will say this: At a dose about one quarter of that which is optimal in animals, this phase one safety study showed improvement in the first cohort that would justify releasing the drug even at suboptimal doses.
Markers of inflammation and fibrosis in the six patients suffering fatty liver disease improved across the board. More importantly, the two patients suffering from the most advanced form of NASH, with associated liver cell death due to fibrosis and inflammation, showed significant reductions in the markers that indicate apoptosis or cell death. This, in one hyphenated word, is world-changing.
It means that the drug, even at low doses that proved safe in this study, reduced the markers of disease progression in earlier stages of the disease. In advanced patients, we saw indications that cellular damage was significantly ameliorated. This means the drug is disease-modifying. It didn’t only prevent worsening. It improved the patients’ condition.
Remember, this short test was at about one quarter of the dose shown optimal in animals. The only thing the company had to prove to move forward was that the compound was not unsafe, and they’ve done that and more. The second cohort can therefore be given higher doses, and I fully expect that efficacy will improve. It will also expand the sample size and strengthen the statistical confidence level of total data.
Almost nobody expected this kind of result. Behind the scenes, I’ve heard that the big companies that had signed NDAs with Galectin Therapeutics were not anticipating signs of efficacy at all. They’ve got to be seriously reassessing right now.
Fortunately for investors who want to increase holding, the stock has not responded to this information. This isn’t surprising because this is new and complicated science. Also, there’s been a concerted effort by the usual suspects to scare traders off this company. I don’t know their motives but this act can’t go on much longer, at least not with any level of credibility.
My only regret about this study is that it’s not doing biopsies. They can’t, though, because biopsies have significant medical risks. Moreover, they are famously unreliable because the tissue samples taken in biopsies are very small. Fibrosis, however, can vary greatly across different regions of a single liver.
My big question is not, however, directly related to liver disease. Theoretically, we know that galectin-3 blockers would also be beneficial for pulmonary fibrosis and other fibrotic diseases, such as my Dupuytren’s contracture. The Wikipedia entry has a list of conditions that should be treatable using this drug candidate or some variation.
Also, of course, cancers are revealed to the immune system when their galectin-3 shields can no longer shut down T cells. In the not-too-distant future, we’ll be able to scan for impacts on all those conditions non-invasively. Today, we can only speculate that multiple fibrotic diseases and cancers are being impacted beneficially in the test patients by the Galectin Therapeutics drug candidate. This compound is, therefore, a natural for many off-label uses."
Kelt
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