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Faith & CultureThis morning, Aegis Capital analyst Raghuram Selvaraju published an update on Galectin Therapeutics. Noting GALT’s “commanding patent position,” he writes that Galectin’s GR-MD-02 is very likely to become the “best in class” drug in the liver fibrosis / NASH space, and reiterates Aegis’ Buy rating on GALT and short-term price target of $32.00 per share. He also notes that La Jolla Pharmaceutical’s “competing” GCS-100 gives you a nasty rash: yikes! By contrast, our drug, so far at least, has proven completely safe.
by Raghuram Selvaraju
Aegis Update
April 23, 2014
Galectin Completes Second Cohort Enrollment
Phase 1 Trial Second Cohort Enrollment Ends. This morning, Galectin Therapeutics announced that it has completed the enrollment of eight patients in the second cohort of its ongoing Phase 1 clinical trial of GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) who have advanced fibrosis. This cohort is receiving GR-MD-02 at a dose level of 4mg/kg, double the dosage given in the first cohort. We anticipate that this second cohort should yield data in late summer 2014. The Phase 1 study is expected to conclude late this year. Since the first cohort data were so encouraging, with indications of GR-MD-02 therapeutic activity on multiple endpoints including biomarkers of both inflammation and fibrosis, we expect even more positive data to be obtained with the second cohort given the increased dose being administered. In anticipation of further evidence of efficacy for GR-MD-02 in liver fibrosis, we reiterate our Buy rating and 15-month price target of $32.00 per share on GALT, our favorite pick in the liver fibrosis space.
Patent Position Commanding, In Our View. We continue to believe that Galectin Therapeutics represents the leader in the domain of galectin inhibition as a therapeutic approach. Suggestions that competitors may hold blocking intellectual property (IP) are spurious, in our view, particularly given the extensive work done by Galectin from the perspective of testing galectin inhibitors in liver fibrosis models and considering the pioneering research by Dr. Anatole Klyosov, Galectin’s founder emeritus, in the areas of carbohydrate-based drug design and characterization of galectin function in diseases. We believe that Galectin holds a commanding position in the galectin inhibition field and that this could permit the company to ascend to the best-in-class position in the domain of liver fibrosis therapy. Competing compounds, particularly GCS-100 from La Jolla Pharmaceutical Co. (LJPC/NASDAQ, Not Rated), have not shown comparable efficacy to GR-MD-02, in our view. Furthermore, GCS-100 has shown dose-limiting toxicity in early human studies consisting primarily of Grade 3 erythematous popular rash, while GR-MD-02 has thus far exhibited a clean safety profile.
Additional Clinical Studies Planned. Pending positive results across all cohorts in the ongoing Phase 1 study of GR-MD-02, Galectin should be ready to begin a robustly-powered Phase 2 trial in NASH patients early in 2015. This trial would be designed to include liver biopsy data, which in our view could conclusively reveal the fibrosis-reversing capacity of GR-MD-02. Further assessment of the activity profile of GR- MD-02 is also planned in both lung and kidney fibrosis. The firm also is working with Providence Portland Medical Center on an investigator- sponsored Phase 1 trial to evaluate Yervoy (ipilimumab) and GR-MD-02 in metastatic melanoma, slated to begin imminently. This trial is based on preclinical data that have shown the synergistic anti-tumor impact of combining immune checkpoint inhibitors like ipilimumab with GR-MD-02 in syngeneic mouse cancer models.
Rod is one of our nation’s leading minds. He’s smart, original, and very committed—a combination that one rarely finds.
Rod Martin and [former Howard Dean campaign manager] Joe Trippi are America’s two foremost experts on online politics.
Rod Martin is a Reaganite-Thatcherite conservative…[and] a man who has spent much of his life ministering to and working for the benefit of others. I know Rod as an advocate for freedom, a leader who understands the real changes we need in Washington, and who has the drive and ability to make those changes happen.
Rod Martin is the kind of dynamic leader who has the knowledge, ability and experience to lead us successfully into the 21st Century. His vision for America is compelling.
Rod Martin literally wrote the book on excellence. Humble yet brilliant, a man of love and compassion, with penetrating clarity he illuminates the world around us, and we are both stirred and enlightened.
Rod Martin is a born leader and an outstanding political mind. Anyone who takes him on is going to have a serious fight on their hands.
Rod Martin is a man of uncommon vision and character. Ever since I first worked alongside Rod in the early days of PayPal, I’ve been struck by his powerful vision for the future. Rod understands the intersection of technology, politics and culture in a way that few others do.
Rod Martin wears with uncommon grace an uncanny ability to link his vigorous faith to the practical challenges of both the business world and the political arena. Yet the respect he shows for others carries a warmth and modesty that are both too rare among those who are strong advocates of feisty positions.
America badly needs more leaders who really get the future. We need more Rod Martins.
Rod Martin is a modern day philosopher-statesman. He is a capitalist intellectual, a conservative iconoclast, a gentle adversary and a kind prophet. He inspires us towards a fresh national vision built upon the original founding principles.
Rod Martin is not only effective and efficient, but he is also perceptive, wise and gracious. He gets things done. He is a great friend and a great ally.
Rod is one of the sharpest, most gracious men I know, and one of the most gifted political thinkers today. His ability to analyze issues and communicate thoughtful insights on them have earned him the respect of people across the political spectrum.
I am proud to have been Rod Martin’s friend for a quarter century, and I can tell you that he is one of the finest men and most outstanding leaders in our church and in our country today. He has a knack for turning everything he touches to success.
Rod Martin is a cornucopian entrepreneur and eutropic thinker whose influence radiates through an array of companies, institutions, movements and churches. A renaissance American, he is also a prolific friend of freedom and faith around the globe.
If Rod Martin represents the next generation of leaders, America has nothing to worry about.
A leader and a servant, in public life and in private, Rod Martin strides at the top of his profession, and has nowhere to go but up. He is in the truest sense of the word ‘outstanding’.
Rod Martin is undoubtedly one of the most accomplished thought leaders today. He is a wonderful mentor, a humble role model, and a deep inspiration for the next generation of scientific innovators and entrepreneurs.
Rod’s achievements pale beside his character and his brilliance. He sees what others can’t. He leads when others won’t.
Rod Martin is one of America’s finest young minds.