Starton Therapeutics receives first clinical regulatory authorization for its STAR-LLD program
Starton Therapeutics Inc announced it has received its first Clinical Trial Authorization in the Netherlands to start a Phase 1 study on its STAR-LLD continuous delivery lenalidomide.
STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL).
The study will evaluate the 24-hour bioavailability, safety, tolerability and pharmacokinetics in human subjects compared to oral lenalidomide.
READ: Starton Therapeutics advances transdermal lenalidomide STAR-LLD program following successful skin permeation studies
Phase 1 is an open-label, crossover design used to confirm the plasma concentrations of STAR-LLD versus oral lenalidomide that will be further evaluated in a randomized Phase 1b study in patients with multiple myeloma, Starton told investors.
The firm’s CEO Pedro Lichtinger called the authorization an “important milestone” for the Paramus, New Jersey-based company, highlighting it as Starton’s first clinical regulatory authorization for the STAR-LLD program.
The study provides comparative rapid confirmation of blood levels so that Starton can move in to the clinic in multiple myeloma, chief medical officer Jamie Oliver told shareholders.
“We have designed the most efficient study to meet regulatory requirements, assess safety, and bring STAR-LLD to a patient population as soon as possible,” Oliver added.
Starton said it plans to submit additional regulatory applications in other countries as part of its development approach for STAR-LLD.
Contact Angela at [email protected]
Follow her on Twitter @AHarmantas
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/970760/starton-therapeutics-receives-first-clinical-regulatory-authorization-for-its-star-lld-program-970760.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Please Help Support BeforeitsNews by trying our Natural Health Products below!
Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST
Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST
Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!
HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.
Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup with oxygen!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Smart Meter Cover - Reduces Smart Meter radiation by 96%! (See Video).