NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

• NanOlogy may offer an alternative treatment option for patients
  with bladder cancer
• Investigational drug, NanoDoce, is injected locally into tumor
  resection bed via cystoscope guidance followed by intravesical
  instillation

FT. WORTH, Texas–(BUSINESS WIRE)–NanOlogy,
a clinical-stage oncology company, today announced the first patient has
been enrolled in a clinical
trial of NanoDoce (sterile submicron particle docetaxel suspension)
for treatment of bladder cancer. The Phase 1/2 dose-rising trial will
evaluate the safety and preliminary efficacy of NanoDoce for patients
with high-risk non-muscle invasive bladder cancer (NMIBC) and muscle
invasive bladder cancer (MIBC).

In 2019, an estimated 80,000 new cases of bladder cancer will be
diagnosed in the United States and an estimated 18,000 will die from the
disease. Despite being one of the top five cancer diagnoses in the U.S.,
the last drug FDA approved for NMIBC was more than a decade ago. Of all
cancers, bladder cancer tends to have the highest lifetime treatment
costs due to the frequency of recurrence, progression to MIBC often
requiring removal of the bladder (cystectomy), and lifetime cost of care
thereafter.

In the NanOlogy clinical trial, following transurethral resection of the
bladder tumor, subjects will receive direct injections of NanoDoce into
the base of the index tumor resection site in combination with an
intravesical instillation of NanoDoce. Additional intravesical
instillations of NanoDoce will be administered to NMIBC subjects while
MIBC subjects will follow institutional standard of care.

The local delivery of submicron particle docetaxel suspension [NanoDoce]
represents an important step in evaluating new therapies for the
treatment bladder cancer”, said Dr. Donald Lamm, MD, President of BCG
Oncology and principal investigator on the trial. “Preclinical studies
suggest the submicron particle technology improves both the penetration
of drug into the bladder wall and its duration of activity. If this
investigational drug can be proven to delay or prevent disease
progression and need for cystectomy, it would contribute significantly
to the quality of life of patients with this disease.”

An abstract
from preclinical studies of NanoDoce was presented in February at the
2019 Genitourinary Cancer Symposium. In one of the studies, NanoDoce
administered via intratumoral injection resulted in prolonged, high
concentration of drug in tumor tissue, significant tumor regression, and
immune cell infiltration in a xenograft animal model of transitional
cell bladder carcinoma. The immune cell infiltration is of particular
interest to NanOlogy for future research into the role NanoDoce may play
in combination with immunoncology therapy for the treatment of advanced
disease.

This work is in addition to extensive preclinical and clinical
development programs underway by NanOlogy in peritoneal/ovarian
cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts,
renal cell carcinoma, non-small cell lung cancer, and cutaneous
metastases.

All NanOlogy investigational drugs are progressing under FDA’s
streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron
particle technology platform is based on a patented production process
that reduces the size of paclitaxel and docetaxel API crystals by up to
400 times into stable submicron particles of pure drug with
exponentially increased surface area and unique geometry. The submicron
particles are so unique they are protected under a composition of matter
patent (US
9,814,685) valid until 2036, which provides new molecular
entity-like advantages without the risks and timeline associated with
NME drug development.

About NanOlogy

NanOlogy, LLC (www.nanology.us)
is a private clinical stage oncology company formed in 2015 to finance
and clinically develop a patented submicron particle technology platform
for local, sustained delivery of proven drugs aimed at increasing their
safety and efficacy in the treatment of cancer and related conditions.

Disclaimers

This announcement contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended, including
statements about our product development, business, and other
activities. Such statements are subject to the risks and uncertainties
inherent in any pharmaceutical development program which may cause
actual results to differ materially due to developmental, clinical
trial, regulatory, market, competitive, technological, or other factors.
All forward-looking statements are made as of the date of this
announcement and the company disclaims any intent or obligation to
update these statements. NanOlogy investigational drugs have not been
proven to be safe and effective in accordance with the requirements of
the U.S. FDCA and have not been approved by FDA for commercial
distribution.

Contacts

Dan Eramian
Opus Biotech Communications
[email protected]
425-306-8716

Charles Craig
Opus Biotech Communications
[email protected]
404-245-0591