Starton Therapeutics has dosed the first patient in the Phase Ib subcutaneous administration of low-dose lenalidomide (STAR-LLD) clinical trial to treat multiple myeloma (MM).
The study, which is anticipated to be carried out in up to three clinical sites, will evaluate the efficacy, tolerability, safety, pharmacokinetics, clinical response, immune biomarkers and signals of the efficacy of lenalidomide in MM patients.
It will also provide signals of efficacy in assessing progression-free survival, duration of response, response rates, and changes in minimal residual disease.
Six second-line transplant-ineligible patients will be enrolled and receive lenalidomide daily in a 28-day cycle along with bortezomib (Velcade) and dexamethasone.
The full enrolment of six patients is anticipated in ten months and the dosing will be provided for three weeks to these patients after the first site is opened.
Multiple safety and efficacy readings from the trial are anticipated during the next six to 18 months.
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Starton Therapeutics chief medical officer Dr Jamie Oliver said: “Lenalidomide has been an effective immunomodulatory drug in hematologic malignancies for years.
“However, adverse events have limited its use in certain patient settings, depriving patients of the full benefits the medicine can offer.
“We believe STAR-LLD may be able to expand the use of lenalidomide where the oral form is not used today.”
In a Phase I bioavailability study, healthy men showed greater than 91% bioavailability when STAR-LLD is given subcutaneously compared to oral Revlimid.
Lenalidomide is also being developed to treat chronic lymphocytic leukaemia.
Starton has also signed an agreement for a business combination with blank check company Healthwell Acquisition.