NanOlogy to Present Positive Preclinical Data for NanoDoce® in Treatment of Uro-Oncologic Cancers at 2019 Genitourinary Cancers (ASCO-GU) Symposium

  • Intratumoral delivery of NanoDoce in multiple murine xenograft
    studies resulted in prolonged, high concentration of drug in tumor
    tissue, significant tumor regression, and immune cell infiltration

FT. WORTH, Texas–(BUSINESS WIRE)–NanOlogy,
a clinical-stage oncology company, will present an abstract at the 2019
Genitourinary Cancer Symposium
, co-sponsored by the American Society
of Clinical Oncology (ASCO), held February 14-16, 2019 in the Moscone
West Building, San Francisco.

Data from preclinical studies of NanoDoce (submicron particle docetaxel
suspension) administered via intratumoral injection will be presented
showing prolonged, high concentration of drug at the tumor site and
significant tumor regression in multiple xenograft animal models
including clear cell renal carcinoma (768-O cell line), transitional
cell bladder carcinoma (UM-UC-3 cell line), and prostate carcinoma (PC-3
cell line). Abstract title, location, and times follow:

Title:   Evaluation of submicron particle docetaxel directly injected into
uro-oncologic xenografts
Poster Session: B – Prostate Cancer; Urothelial Carcinoma; Penile, Urethral,
Testicular, and Adrenal Cancers
Where: Board E17 Abstract #360, West Building Moscone, San Francisco
When: Friday, February 15, 2019, 12:15 to 1:45 PM and 5:15 to 6:15 PM

Data from the preclinical studies showed that tumor volume decreases
with two and three intratumoral doses of NanoDoce were significantly
greater than or similar to IV docetaxel. Immunohistochemistry
evaluations for the renal and bladder cancer models revealed immune cell
infiltration in NanoDoce-treated animals. Drug was detected in
NanoDoce-treated tumor tissue up to 50 days after administration, and at
levels far greater than IV-treated animals.

Persistent, therapeutic levels of docetaxel from intratumoral NanoDoce
appear to kill tumor cells through direct and indirect means. NanoDoce
is known to directly inhibit tumor cell mitosis, and its persistence
results in prolonged release of tumor antigen, which appears to promote
indirect immune cell-mediated tumor kill.

A clinical
trial
in high-risk non-muscle invasive (NMIBC) and muscle invasive
bladder cancer (MIBC) will begin enrollment in the first quarter of this
year. Following transurethral resection of bladder tumor, subjects will
receive direct injections of NanoDoce into the base of the index tumor
resection site in combination with intravesical instillations of
NanoDoce.

In addition, IND-enabling studies are nearing completion on NanoDoce for
renal cell carcinoma to allow for a clinical trial via intratumoral
injection in the second half of 2019. This work is part of an extensive
preclinical and clinical
development program
underway by NanOlogy in peritoneal cancers,
prostate cancer, pancreatic cancer, pancreatic mucinous cysts, breast
cancer, 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 that they are protected under a composition of
matter patent (US
9,814,685
) valid until 2036 in the US, 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 value
in the treatment of cancer and related conditions.

Disclaimer

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 by FDA 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

error: Content is protected !!