DFB Soria Completes a Phase 2 Clinical Trial of Submicron Particle Paclitaxel Anhydrous Ointment for Actinic Keratosis
September 18 2018 - 5:30AM
Business Wire
Soria investigational drug provides evidence of
actinic keratosis (AK) lesion reduction without the local
irritation of approved topical AK treatment products
DFB Soria, a DFB Pharmaceuticals company, today announced
completion of a dose-rising clinical trial of a topically applied
submicron particle paclitaxel suspended in a pharmaceutically
elegant, preservative-free anhydrous base. The trial was designed
to evaluate safety and preliminary efficacy of four strengths of
the product applied twice daily for 28 days. Results from the trial
show evidence of AK lesion reduction in size and count, dose
response, and minimal local irritation or other side effects.
AK affects 58 million Americans and is caused by exposure to the
sun and other sources of UV radiation. The condition is responsible
for 8 million visits to dermatologists or primary care physicians
in the US annually. Left untreated, AK can progress to squamous
cell carcinoma (SCC), the second most common form of skin cancer.
Each year, more than one million people are diagnosed with SCC and
as many as 9,000 people die from the disease. IV Paclitaxel is
approved by FDA for the treatment of advanced SCC, which provided
Soria the rationale for developing its topical product for AK.
“The most widely prescribed topical treatment for AK contains
5-fluorouracil, which causes severe dermal irritation and
significantly decreases quality of life for several weeks during
use,” said Gere diZerega, MD, VP of Medical Affairs. “Our goal was
to demonstrate our product would result in AK lesion reduction
without the severe irritation that limits other topical products.
We now may identify a pharma partner or proceed ourselves as the
results from this trial allow us to move forward with a dose
confirmation trial followed by a pivotal phase 3 trial if
successful.”
The submicron particle paclitaxel contained in the Soria product
is produced by a proprietary production technology that reduces the
size of unprocessed paclitaxel API crystals up to 400 times into
stable, uncoated particles of pure drug with exponentially
increased surface area and unique geometry. The particles are so
unique they have been granted a composition of matter patent
(US 9,814,685) that is valid until 2036. This provides the
product new molecular entity-like IP advantages with a streamlined
505(b)2 FDA regulatory pathway.
NanOlogy, LLC, a company related to Soria, is also underway on a
phase1/2 clinical trial of a similar topical product for the
treatment of cutaneous metastases, which is expected to complete in
early 2019. Cutaneous metastases are skin lesions secondary to
certain metastatic cancers and represents an unmet medical need
because no approved topical treatments exist for common forms of
the condition.
The company is evaluating options for bringing both products to
regulatory approval including sale or license to a
dermatology-focused company or continued internal investment.
NanOlogy has an exclusive license for the submicron particle
production technology with investigational drugs currently in
clinical trials for peritoneal malignancies (with orphan drug
status), prostate cancer, pancreatic cancer, and pancreatic
mucinous cysts. In addition, clinical trials are planned by
NanOlogy in bladder cancer in late 2018 and in lung cancer and
renal cancer in 2019.
About Soria and NanOlogy
DFB Soria, LLC (www.dfbsoria.com) is owned and operated by DFB
Pharmaceuticals LLC. Soria developed its submicron particle
paclitaxel anhydrous ointment under an exclusive worldwide license
from CritiTech, Inc. for dermatology. NanOlogy, LLC is a private
clinical stage pharmaceutical company formed in 2015 to finance and
clinically develop the submicron particle technology platform for
local, sustained delivery of chemotherapeutic agents aimed at
increasing their safety and efficacy 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 and
Soria 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 U.S. FDA for commercial distribution.
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Opus Biotech CommunicationsDan Eramian,
425-306-8716daneramian@comcast.netorOpus Biotech
CommunicationsCharles Craig,
404-245-0591charles.s.craig@gmail.com