OTITOPIC™ Pursues Additional New Indication for Dry Powder Inhalation of Aspirin as a Treatment for Non-Small-Cell Lung Cancer (NSCLC)

OTITOPIC™ Pursues Additional New Indication for Dry Powder Inhalation of Aspirin as a Treatment for Non-Small-Cell Lung Cancer (NSCLC)

April 8, 2019 Off By BusinessWire

LOS ANGELES–(BUSINESS WIRE)–OTITOPIC™ recently announced a new additional indication for treatment
of lung cancer for its aspirin inhalation product. Delivering an inhaled
Dry Powder formulation of Aspirin directly into the deep sites of the
lung is a novel new approach to lung cancer treatment. This new
treatment can potentially provide benefits superior to other common
therapies greatly improving clinical outcomes for patients being treated
for lung cancer.

Lung cancer is one of the leading causes of morbidity and mortality
among all malignant tumors worldwide. Small-cell lung cancer (15%–20%)
and non-small-cell lung cancer (NSCLC) (80%–85%) are the main types of
lung cancer.

Clinical treatments of primary lung cancer mainly include surgery,
radiotherapy and chemotherapy. Treatments for lung cancer commonly use
at least two chemotherapeutic agents which are administered orally or
injected. The most common clinical treatments result in whole-body
exposure to toxic chemotherapeutic agents with significant side effects
and relatively low local concentrations of chemotherapeutic agents at
the lung where the tumor is located.

Aspirin is one of the most studied and most popular products used in the
past century. Aspirin has been demonstrated to have extensive
pharmacological activities including anti-inflammation, anticancer and
pain-relieving activities. Aspirin also inhibits platelets and has blood
thinning properties which are beneficial in preventing and treating
heart attacks.

Several epidemiological studies have correlated regular aspirin use with
decreased lung cancer risk. These epidemiological findings suggest a
potential inhibitory effect of Aspirin on the growth and development of
lung cancer cells and disease progression. Also, a recent study using
cancer-like cultured cells as a model system for lung cancer found that
incubation of these cells under hypoxic conditions with aspirin
inhibited cell proliferation and arrested the cell cycle at the G2/M
stage, preventing cell division. The conversion of cells to a less
differentiated stem-like state characteristic of malignant cancer cells
was also inhibited as well as the release of exosomes which increase
cancer malignancy. Another study in nude mice inoculated with cancer
cell lines found that the amount of cancer tissue metastasized to the
lung was reduced in mice administered aspirin orally for six weeks after
inoculation with the cancer cell lines relative to controls.
Additionally, since the Inhibition of COX-2 by aspirin is well
established, studies provided evidence that the COX-2 enzyme is
upregulated in metastatic cancer cells and that Aspirin prevents tumor
progression by inhibiting the COX-2 enzyme. Unfortunately, excessive
bleeding and gastric side effects limit the oral aspirin tablet doses
which can be administered for cancer therapy, making it difficult to
achieve the high concentrations of aspirin required in the lung for
optimal cancer therapy using oral aspirin.

OTITOPIC™’s main asset is ASPRIHALE™ (Dry Powder Inhalation of Aspirin
drug/Device combination product), which delivers aspirin directly to the
lung by oral inhalation, achieving high local concentrations of aspirin
in lung tissue upon inhalation. By delivering high local concentrations
of aspirin directly to the lung tissue upon inhalation, our clinical
plans are:

1- Inhibit cell proliferation and arrest the cell cycle at the G2/M stage
2-
preventing cell division
3- Inhibit growth and development of lung
cancer cells and disease progression
4- Prevent tumor progression
by inhibiting the COX-2 enzyme.

Our successful TOX studies have shown local delivery of aspirin directly
to the lung by dry powder inhalation is safe. Lung cancer therapy is a
potential new indication for ASPRIHALE™ which may be a superior and
safer treatment than oral aspirin tablets.

About OTITOPIC™

OTITOPIC™ (http://otitopic.com/)
is a privately funded drug development company in clinical stage with a
track record of success in Pharmaceutical product drug delivery and drug
device development. ASPRIHALE™ is a proprietary Dry Powder Inhalation of
aspirin formulation delivered via portable dry powder inhaler (DPI) that
is expected to enter the bloodstream faster than oral tablets at the
time of MI. OTITOPIC™ is on track with ASPRIHALE™ to file an NDA for a
novel drug-device combination product in rescue management of suspected
acute myocardial infarction (MI). OTITOPIC™ is committed to providing
high-risk MI patients with a faster alternative for management of
suspected myocardial infarction (MI). Additionally, OTITOPIC™ is
actively exploring new additional indication for treatment of lung
cancer for its aspirin inhalation product, such as delivering inhaled
dry powder formulation of Aspirin directly into the deep sites of the
lung for treatment of lung cancer.

Contacts

Kambiz Yadidi
[email protected]
877-443-8710