Inhibikase Says FDA Clears IND For IkT-001Pro To Treat Chronic Myelogenous Leukemia

RTTNews | 1073 dias atrás
Stocktwits
Inhibikase Says FDA Clears IND For IkT-001Pro To Treat Chronic Myelogenous Leukemia

(RTTNews) - Pharmaceutical company Inhibikase Therapeutics, Inc. (IKT) announced Friday that the U.S. Food and Drug Administration (FDA) has reviewed its Investigational New Drug (IND) application for IkT-001Pro for the treatment of Chronic Myelogenous Leukemia (CML) and issued a Study May Procced (SMP) letter.

IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (marketed as Gleevec).

IkT-001Pro has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major and/or complete cytogenetic responses in stable-phase CML.

In preclinical studies, IkT-001Pro was shown to be as much as 3.4 times safer than imatinib in non-human primates, reducing burdensome gastrointestinal side effects that occur following oral administration.

Imatinib delivered as IkT-001Pro was granted Orphan Drug Designation for stable-phase CML in September, 2018.

IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and will enroll approximately 64 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses.

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Australian Market Extends Early Losses In Mid-market

Australian Market Extends Early Losses In Mid-market

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RTTNews | 1h 47min atrás
Asian Markets Trade Mixed

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RTTNews | 2h 28min atrás
Thai Stock Market Expected To Open In The Red Again On Monday

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RTTNews | 3h 30min atrás
Indonesia Bourse May Turn Lower Again On Monday

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RTTNews | 4h 0min atrás
Japanese Market Sharply Lower; Down 2%

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RTTNews | 4h 0min atrás
No Help Yet For Hong Kong Stock Market

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The Hong Kong stock market has tracked lower in four straight sessions, dropping more than 1,050 points or 4 percent along the way. The Hang Seng Index now rests just above the 24,500-point plateau and it's expected to open in the red again on Monday.
RTTNews | 4h 15min atrás
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