Senzer Secures US Clinical Data Package for the Treatment of Chemotherapy Induced Adverse Events

London (ots/PRNewswire) - Senzer has secured the Investigational New Drug
application and data package for its ongoing FDA registration programme from its
former US strategic partner and will now push ahead to get its cannabinoid
respiratory device approved for treating side effects induced by anti-cancer
treatments in the world's largest pharmaceutical market, the Company said today.

Work commenced on a 505(b)(2) clinical programme approval pathway more than four
years ago to use Senzer's device for the treatment of side effects linked to
chemotherapy, specifically nausea and vomiting, and neuropathic pain. However,
the US licensee, Insys Therapeutics has since gone into administration. Senzer
has now assumed full rights to the data package and all supporting documents for
the IND.

The IND data package includes all work to date, namingly FDA-registered safety,
tolerability and bioequivalence studies. The package also holds Phase I clinical
results, which Insys has reported to be positive, with cannabinoids delivered
via Senzer's proprietary inhalation device shown to be well tolerated in trials
of healthy subjects. The study compared oral administration of Marinol, an
approved synthetic form of the cannabinoid THC (dronabinol) as an anti-emetic,
compared to Senzer's inhaled dronabinol. The study showed that Senzer's inhaled
dronabinol, proved to be swiftly and effectively taken up into the bloodstream,
reaching maximal plasma concentration within 2 minutes compared with 1.53 hours
through Marinol oral administration. Additionally, Senzer's inhaled formulation
proved to require significantly less (14 times less) dronabinol compared to
Marinol -- 0.35mg inhaled versus 5mg oral administration -- to achieve similar
plasma concentrations.

"Securing the IND package will allow us to build on all the quality work to
date, and means we can now go straight into resolving clinical trials to explore
further how our unique approach can help those suffering from chemotherapy side
effects," said Senzer CEO Alex Hearn. "We have always looked to the US as a key
market we wish to enter, and I know my team are very excited to be getting our
FDA approval programme back on track again."

Senzer's breath-activated device is supported by more than 400 patents, and
delivers a standard dose of cannabinoid formulations from a pressurised
cannister, ensuring the reactive compounds are well protected from heat, light
and oxygen. Senzer already has approval in Europe as a Class II(a) medical
device, and will shortly be available in the UK and EU markets as an unlicensed
medicine to address any individual clinical need of a patient when a suitable
licensed medicine is not available. The device will also be provided through the
world's largest medical cannabis usage project, Twenty21, which aims to treat
some 20,000 UK patients with cannabinoids for six conditions.

About SENZER

SENZER Ltd. is a U.K.-based inhalation technology company specializing in the
development and commercialization of therapeutic delivery systems of cannabinoid
products, and it is developing a pipeline of inhalation and delivery products to
meet unmet medical needs. Senzer's platform is based around a patented device
that allows swift and effective inhaled delivery of cannabinoids, in a
consistent dose-controlled presentation.

www.senzer.com

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Contact:

Samantha Simpson
+44(0)203-457-0453
press@senzer.com

Additional content: https://www.presseportal.de/pm/131299/4541835
OTS: Senzer Limited

Original-Content von: Senzer Limited, übermittelt durch news aktuell