Breaking News
December 13, 2018 - Zogenix Announces Positive Phase 3 Trial Results on the Efficacy and Safety of Fintepla (ZX008) in Dravet Syndrome
December 13, 2018 - BCR ABL Genetic Test: MedlinePlus Lab Test Information
December 13, 2018 - Caffeinated beverages during pregnancy linked to lower birth weight babies
December 13, 2018 - Stanford Medicine Health Trends Report examines opportunity to democratize health care
December 13, 2018 - Obsessive-compulsive disorder may protect individuals from obesity
December 13, 2018 - Scientists investigate how a painful event is processed in the brain
December 13, 2018 - Genetic study reveals new insights into underlying causes of moderate-to-severe asthma
December 13, 2018 - Vitamin C supplementation for pregnant smokers may reduce harm to infants’ lungs
December 13, 2018 - New study reveals yin-yang personality of dopamine
December 13, 2018 - Long-term Benefit of Steroid Injections for Knee Osteoarthritis Challenged
December 13, 2018 - Adding new channels to the brain remote control
December 13, 2018 - In the Spotlight: A different side of neuroscience
December 13, 2018 - Medical Marvels: Using immunotherapy for melanoma that spread to the brain
December 13, 2018 - Puzzles do not keep dementia away finds study
December 13, 2018 - New mouse model shows potential for rapid identification of promising muscular dystrophy therapies
December 13, 2018 - Study reveals urban and rural differences in prenatal exposure to essential and toxic elements
December 13, 2018 - New collaborative partnership in quest of novel antibiotics
December 13, 2018 - Single tau molecule holds clues to help diagnose neurodegeneration in its earliest stages
December 13, 2018 - AHA Scientific Statement: Low Risk of Side Effects for Statins
December 13, 2018 - What Is Acute Flaccid Myelitis?
December 13, 2018 - How bereaved people control their thoughts without knowing it
December 13, 2018 - Health care democratization underway, according to 2nd annual Stanford Medicine Health Trends Report | News Center
December 13, 2018 - Going Beyond a Single Color
December 13, 2018 - London-based startup launches ‘thedrug.store’ aiming to clean up CBD industry
December 13, 2018 - Loss of tight junction barrier protein results in gastric cancer development
December 13, 2018 - Novel way to efficiently deliver anti-parasitic medicines
December 13, 2018 - RKI publishes new data on disease prevention and utilization of medical services
December 13, 2018 - High-tech, flexible patches sewn into clothes could help to stay warm
December 13, 2018 - The CCA releases three reports on requests for medical assistance in dying
December 13, 2018 - Restoring Hair Growth on Scarred Skin? Mouse Study Could Show the Way
December 13, 2018 - Probiotic use may reduce antibiotic prescriptions, researchers say
December 13, 2018 - Drug repositioning strategy identifies potential new treatments for epilepsy
December 13, 2018 - Chronic rhinitis associated with hospital readmissions for asthma and COPD patients
December 13, 2018 - Food poisoning discovery could save lives
December 13, 2018 - Cloned antibodies show potential to treat, diagnose life-threatening fungal infections
December 13, 2018 - Exercise may reduce colorectal cancer risk after weight loss
December 13, 2018 - Russian scientists create hardware-information system for brain disorders treatment
December 13, 2018 - Moderate alcohol consumption linked with lower risk of hospitalization
December 13, 2018 - Nurturing Healthy Neighborhoods | NIH News in Health
December 13, 2018 - Rise in meth and opioid use during pregnancy
December 13, 2018 - Researchers gain new insights into pediatric tumors
December 13, 2018 - FSU study finds racial disparity among adolescents receiving flu vaccine
December 13, 2018 - Study investigates attitudes toward implementation of ‘sex as a biological variable’ policy
December 13, 2018 - Drug cocktail induces cancer cell death by switching off energy supply
December 13, 2018 - Baculovirus virion completely eliminates liver-stage parasites in mouse model
December 13, 2018 - Researchers create noninvasive technology that detects when nerve cells fire
December 13, 2018 - Allen Institute for Immunology to partner with CU Anschutz to understand dynamics of human immune system
December 13, 2018 - Inability to do daily living tasks delays discharge of mental health patients
December 13, 2018 - Treating patients with hypertension induced albuminuria
December 13, 2018 - New substance could improve efficacy of established breast cancer treatments
December 13, 2018 - Scientists develop new stem cell line to study conversion of stem cells into muscle
December 13, 2018 - Re-programming the body’s energy pathway boosts kidney self-repair
December 13, 2018 - Research findings could help improve treatment of anxiety and post-traumatic stress disorders
December 13, 2018 - The Microbiome Movement announce Microbiotica as official industry partner
December 13, 2018 - New study reveals potential benefits of cEEG monitoring for infant ICU patients
December 13, 2018 - Whole-body imaging PET/MRI offers information to guide treatment options for prostate cancer
December 13, 2018 - International investigators fight against the negative campaign on benzodiazepines
December 13, 2018 - Targeting biochemical pathway may lead to new therapies for alleviating symptoms of anxiety disorders
December 13, 2018 - FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections
December 13, 2018 - Are scientists studying the wrong kind of mice?
December 13, 2018 - Computer memory: A scientific team builds a virtual model of a key brain region
December 13, 2018 - Visual inspection alone is insufficient to diagnose skin cancer
December 13, 2018 - Paternal grandfather’s access to food associated with grandson’s mortality risk
December 13, 2018 - Our brain senses angry voices in a flash, study shows
December 13, 2018 - PM2.5 Exposure Linked to Asthma Rescue Medication Use
December 13, 2018 - Can’t exercise? A hot bath may help improve inflammation, metabolism, study suggests
December 13, 2018 - Can artificial intelligence help doctors with the human side of medicine?
December 13, 2018 - Virginia Tech and UC San Diego researchers team up to develop nonopioid drug for chronic pain
December 13, 2018 - NIH offers support for HIV care and prevention research in the southern United States
December 12, 2018 - Activating brain region could revive the urge to socialize among opioid addicts
December 12, 2018 - Relationship impairment appears to interfere with seeking mental health treatment in men
December 12, 2018 - Sleep, Don’t Cram, Before Finals for Better Grades
December 12, 2018 - Effective treatments for urticarial vasculitis
December 12, 2018 - Gun violence is a public health issue: One physician’s story
December 12, 2018 - The Science of Healthy Aging
December 12, 2018 - Yes to yoghurt and cheese: New improved Mediterranean diet
December 12, 2018 - Researchers uncover a number of previously unknown insecticide resistance mechanisms
December 12, 2018 - Regulating the immune system’s ‘regulator’
December 12, 2018 - In breaking bad news, the comfort of silence
December 12, 2018 - Study finds upward link between alcohol consumption and physical activity in college students
GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia

GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia

image_pdfDownload PDFimage_print

ROCKVILLE, Md.–(BUSINESS WIRE)–Nov. 19, 2018– GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in the company’s Phase 3 clinical trial of uproleselan (GMI-1271) in relapsed/refractory AML. The trial’s protocol provides for administration of the investigational drug in combination with MEC (mitoxantrone, etoposide and ara-C) or in combination with FAI (fludarabine, ara-C and idarubicin), both of which are standard of care for this indication in the United States. In 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to GlycoMimetics for uproleselan in this patient population. The company anticipates the initiation of two complementary Phase 2/3 trials from two leading clinical consortia in early 2019.

“The dosing of the first patient in our pivotal Phase 3 trial for uproleselan is an important milestone for GlycoMimetics,” said Helen Thackray, M.D., FAAP, Senior Vice President, Clinical Development, and Chief Medical Officer of GlycoMimetics. “This is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of individuals living with relapsed/refractory AML. The trial is an important component of our comprehensive late-stage development program for uproleselan that positions us to evaluate the use of our product candidate across the spectrum of AML. It is the first of three randomized, controlled trials for uproleselan in AML, which we believe should provide clear efficacy and safety outcome measures in each of the settings being assessed.”

“Our clinical development pipeline sets us up for multiple, value-creating clinical data readouts,” added Rachel K. King, GlycoMimetics Chief Executive Officer. “During 2019, we anticipate topline data from the Phase 3 study of rivipansel being conducted by Pfizer in patients with sickle cell disease. Then, beginning at the end of 2020, we expect to generate topline data from the several trials that we will have underway in AML.”

GlycoMimetics plans to enroll approximately 380 adult patients worldwide in the single pivotal randomized, double-blind, placebo-controlled Phase 3 AML trial, which is designed to align with guidance received from regulatory agencies. The primary endpoint is overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling. The majority of the study sites will be in the United States, with meaningful participation from leading clinical centers in other strategic countries to support regulatory filings in major markets.

More information on the clinical trial can be found at www.clinicaltrials.gov.

About Uproleselan (GMI-1271)

Uproleselan (yoo’ pro le’sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival, as well as lower than expected induction-related mortality rates, as compared to historical controls which have been derived from results from third party clinical trials evaluating standard chemotherapy The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is currently implementing a comprehensive development program across the clinical spectrum of AML. This includes a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial is being sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial is sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics’ most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics’ wholly-owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is currently being evaluated in a company sponsored Phase 3 trial in relapsed/refractory AML. The FDA granted uproleselan Breakthrough Therapy Designation for the treatment of adult acute myeloid leukemia (AML) patients with relapsed/refractory disease. GlycoMimetics has also completed a Phase 1 clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding the clinical development of the company’s drug candidates, including the expected enrollment in and conduct of clinical trials, the presentation of clinical data, and expiration of issued patents. Actual results may differ materially from those in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 6, 2018, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.

Source: GlycoMimetics, Inc.

Posted: November 2018

Tagged with:

About author

Related Articles