Starton Therapeutics Announces Enrollment Completion for STAR-LLD Phase 1b Clinical Trial in Multiple Myeloma
2024年4月25日 - 9:30PM
Starton Therapeutics Inc. (“Starton” or the “Company”), a
clinical-stage biotechnology company transforming standard-of-care
therapies with proprietary dermal technologies, announced today the
successful completion of enrollment for its STAR-LLD Phase 1b
clinical trial in multiple myeloma.
“This milestone marks a significant step forward in
our commitment to bringing more advanced therapies to patients. We
extend our gratitude to the participants, investigators, and
clinical teams whose dedication and collaboration have made this
achievement possible significantly ahead of our original
timelines,” stated Pedro Lichtinger, Chairman and CEO of Starton
Therapeutics. “With enrollment now complete, we are poised to
advance to the next stages of clinical development, furthering our
mission to expand and replace lenalidomide in key segments of MM
and bring to CLL patients a new mode of action with proven
efficacy.”
The study, which is assessing the safety,
pharmacokinetics, and efficacy of continuous subcutaneous
administration of low-dose lenalidomide (STAR-LLD) in combination
with dexamethasone and bortezomib (Velcade®), was originally
anticipated to take ten months to enroll. The Company announced the
opening of its second clinical site in February 2024.
Dr. Jamie Oliver, Starton’s Chief Medical Officer,
added, “In the journey toward groundbreaking healthcare solutions,
it takes unwavering dedication and collaborative spirit to make a
difference. We are profoundly grateful to our esteemed partners at
Gabrail Cancer & Research Center and Regional Medical Oncology
Center for their remarkable commitment to our clinical trial,
tirelessly caring for every patient’s needs along the way. We also
want to thank the patients for their participation in the study.
Together, we are not just advancing science; we are transforming
lives.”
Starton previously disclosed preliminary trial
findings regarding the safety and efficacy of STAR-LLD for multiple
myeloma. Only two drug-related events have been observed to date.
One patient experienced a drug-related intermittent injection site
rash but continued with treatment, and a second patient was
discontinued due to a Revlimid® skin rash. None of the more serious
typical lenalidomide side effects, including neutropenia,
gastrointestinal issues, and severe fatigue, have been observed.
Given that up to 30% of patients discontinue the use of Revlimid®
and approximately 70% undergo dose reduction due to adverse
effects, these findings suggest that STAR-LLD may offer superior
tolerability, potentially expanding the eligible patient
population.
As part of the development plans agreed to with the
FDA, the Company will prepare an initial summary of data on safety
and activity while patients continue treatment for efficacy
endpoints. This interim review for the End of Phase 1 meeting,
anticipated for 4Q24, is aimed at helping develop the plans for the
approval path forward with Phase 2 studies for MM and other
malignancies where lenalidomide has shown activity but is not
approved.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide
(LLD) in development to expand and replace the standard-of-care for
the most common blood cancers, multiple myeloma (MM), and chronic
lymphocytic leukemia (CLL). A preclinical proof-of-concept study
for STAR-LLD demonstrated that MM tumors caused by human myeloma
cells grew 25-fold if untreated, five-fold when treated with daily
lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day
cycle. The study also showed a 100% overall response rate (ORR)
using continuous delivery LLD and 20% of animals in this cohort
were tumor-free after 100 days, compared to a 0% ORR in animals
treated with a 70% higher dose of lenalidomide given in single
daily doses. In addition, a Phase 1 bioavailability study in
healthy men comparing STAR-LLD to Revlimid® demonstrated the drug
is well tolerated and is >91% bioavailable by the subcutaneous
route. It was also observed that the Cmax is <90% lower than
oral Revlimid®.
About Starton Therapeutics
Starton Therapeutics is a clinical-stage
biotechnology platform company focused on transforming
standard-of-care therapies with proprietary continuous delivery
technology, so people with cancer can receive continuous treatment
to live better, longer. Starton’s proprietary transdermal
technology is intended to increase the efficacy of approved drugs,
make them more tolerable, and expand their potential use. To learn
more, visit www.startontx.com.
Forward Looking Statements
All statements other than statements of historical
facts included in this press release, including, without
limitation, statements regarding our plans and objectives for
future operations and expectations about current and future
clinical trials, constitute “forward-looking statements.”
Forward-looking statements are subject to numerous conditions and
known and unknown risks and uncertainties that could cause our
actual results or events to differ materially from those included
within the forward-looking statements.” Readers are cautioned not
to place undue reliance on these forward-looking statements, and
except as required by law, the Company undertakes no obligation to
disclose any revision to these forward-looking statements whether
as a result of new information, future events, or otherwise.
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