Shares of GlycoMimetics Inc. (GLYC) have exploded higher by more than 170% in the last 5 trading days in sharp contrast to the iShares NASDAQ Biotechnology Index (ETF), which is down 1.22% during the same period.
GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease.
Yesterday (May 18, 2017), the Company announced new data from phase 2 portion of its phase 1/2 trial evaluating GMI-1271 as a potential treatment for acute myeloid leukemia (AML) in combination with chemotherapy.
The phase 2 portion of the trial is comprised of two arms, one treating newly diagnosed AML patients 60 years of age and older and the other, treating adult patients with relapsed or refractory disease.
The data from the ongoing phase II trial released yesterday reveals that AML patients treated with GMI-1271, combined with chemotherapy, continue to experience higher-than-expected remission rates and lower-than-expected induction-related mortality rates in both arms of the trial.
GMI-1271 continues to be well tolerated in the patients, and there appears to be no obvious incremental toxicity when GMI-1271 is added to chemotherapy, according to the Company.
GMI-1271 is designated as a Breakthrough Therapy by the FDA for the treatment of adult AML patients with relapsed/refractory disease. The drug candidate also carries the designations of Orphan Drug and Fast Track Status for the treatment of AML.
A phase I clinical trial of GMI-1271 in combination with bortezomib-based chemotherapy in multiple myeloma is also ongoing in Ireland.
The Company’s lead product candidate is Rivipansel for the treatment of vaso-occlusive crisis of sickle cell disease, which is under phase III testing.
Sickle cell disease is an inherited genetic disorder caused by a mutation in the gene that encodes for hemoglobin, resulting in distorted red blood cells. The red blood cells, which become crescent shaped or like a sickle, cling to each other and to the walls of blood vessels, severely impairing the blood flow to the organs. An estimated 100,000 Americans and millions worldwide are affected by sickle cell disease.
The hallmark of sickle cell disease is recurring episodes of severe, debilitating pain commonly known as sickle cell crisis or vaso-occlusive crisis.
Rivipansel is licensed to Pfizer (PFE) by GlycoMimetics under an agreement signed between the two companies in 2011.
The phase III trial of Rivipansel for vaso-occlusive sickle cell crisis is being conducted by Pfizer, and is on track for completion in the second half of 2018.
One more clinical drug candidate in the Company’s pipeline is GMI-1359, a potential treatment for hematologic malignancies. A phase I trial of GMI-1359 in healthy volunteers was initiated by GlycoMimetics last September.
Key Numbers (As of March 31, 2017)
— Accumulated deficit – $126.9 million
— Cash on hand – $34.6 million
— Shares outstanding – 23.85 million
Shares of GlycoMimetics rose as much as 116% to touch a new 52-week high of…