Shares of G1 Therapeutics Inc (NASDAQ: GTHX), an oncology biotech, have climbed to their highest level so far in 2019, courtesy of an announcement from the company regarding trilaciclib, its investigational therapy for bone marrow preservation.
Following a positive end-of-Phase 2 meeting with the FDA and discussions with the European regulators, GI, a thinly traded small-cap biotech, said it plans to submit marketing applications in the U.S. and Europe. The company indicated that the FDA gave written feedback following the meeting.
Trilaciclib is a first-in-class myelopreservation agent that protects bone marrow from chemotherapy damage.
The proposed submissions will be supported by currently available data from three randomized, double-blind, placebo-controlled small cell lung cancer clinical trials, as well as safety data collected across all completed and ongoing clinical trials, according to G1.
Why It's Important
Since chemotherapy doesn't differentiate between cancer cells and healthy cells, it induces bone marrow damage, aka myelosuppression. Bone marrow has important stem cells that produce white blood cells, red blood cells and platelets. Myelosuppression results in anemia and fatigue, while also increasing the risk of infection.
Myelosuppression is currently managed by administration of rescue interventions such as growth factors and blood or platelet transfusions.
"By providing a proactive approach to reduce myelosuppression, trilaciclib improves the patient experience during chemotherapy treatment, reducing side effects and the need for associated interventions commonly given to treat them," Jared Weiss, a trial investigator, said in a statement.
G1 said it expects to have a pre-NDA meeting scheduled with the FDA later this year. Following the meeting, the company said it will provide details regarding the NDA submission and timeline. Subsequent to the NDA filing, the company also plans to submit a Marketing Authorization Application to the European Medicines Agency.
G1 shares were rallying by 18.05 percent to $21.91 at the time of publication Tuesday.
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