U.S. Patent and Trademark Office Grants US Patent # 11,975,112 for “Treatment of Vomiting and Nausea with Minimum Dose of Olanzapine”
2024年5月20日 - 11:36PM
Starton Therapeutics Inc. (“Starton” or the “Company”), a
clinical-stage biotechnology company transforming standard-of-care
therapies with proprietary dermal technologies, announced today
that the U.S. Patent and Trademark Office (USPTO) granted US Patent
# 11,975,112 for “Treatment of Vomiting and Nausea with Minimum
Dose of Olanzapine”.
“We are thrilled with the recent granting by the
USPTO. This not only strengthens our intellectual property but also
validates our continuous delivery platform. Furthermore, it
fortifies our position in the industry, empowering us to innovate
boldly and drive positive change for patients suffering from
nausea,” stated Pedro Lichtinger, Chairman and CEO of Starton
Therapeutics.
Olanzapine, an atypical antipsychotic medication
primarily used to treat schizophrenia and bipolar disorder, has
also shown promise in clinical studies for its effectiveness in
managing chemotherapy-induced nausea and vomiting (CINV) when used
in combination with standard anti-nausea medications. With side
effects such as fatigue and sedation, it is important to identify a
minimum effective dose of olanzapine and find improved compositions
and methods of delivery, such as transdermal patches to achieve
sustained minimum effective doses and avoids the peaks associated
with standard-of-care oral administration.
Olanzapine for prevention of nausea and vomiting
has been tested at doses of 10 mg and 5 mg a day, but without a
pharmacodynamic evaluation. No studies have evaluated the minimum
effective dose in nausea and vomiting. An advantage to transdermal
patch delivery is that high and low blood levels are avoided. In
the case of most drugs, the maximum concentration (Cmax) is
associated with toxicity and the minimum concentration (Cmin) is
usually below the required therapeutic blood level.
Starton conducted an exploratory Phase 1 with
healthy volunteers to determine the minimal effective does of
olanzapine using transdermal application, followed by a comparative
bioavailability study with the optimal formulation compared to the
oral olanzapine dose of 10 mg/day. The patent includes claims that
the Company’s transdermal application provides administering
olanzapine with an AUC (Area Under the Curve) between 20%-80% of
the AUC obtained from the standard of care treatment.
The patent has terms extending to 2041, excluding
any patent term adjustments or patent term extensions that may
provide additional protection. Starton retains full global
ownership of the provisional patent applications with the
technology and methodology being developed internally. STAR-OLZ has
been partnered in China.
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.
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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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