Light Sciences Oncology (MM) (NASDAQ:LSON)
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Light Sciences Oncology (LSO) (NASDAQ:LSON) today announced a major
initiative to strengthen its intellectual property position and extend
the range of its Light Infusion Therapy (Litx™).
On December 29, 2006, LSO purchased the assets of its former parent
company, Light Sciences, LLC (LSLLC) through the issuance of common
stock. As a result of the purchase, LSO now owns all patents and
substantially all of the other assets of LSLLC and its subsidiaries:
Visient Therapeutics, Inc.; Vascular Reconditioning, Inc.; Light
Devices, Inc.; Light Sciences Adipose, Inc.; and Light Sciences R&D, LLC.
According to LSO’s CEO Llew Keltner, M.D.,
Ph.D., “The acquired assets will allow us
unencumbered access to the key technologies for our current and future
products—along with a strong foundation for
expansion globally and therapeutically. Our expanded intellectual
property portfolio is especially important strategically as a commercial
advantage.”
LSO now owns a number of patents and patent applications formerly
licensed from LSLLC covering LEDs and the use of LEDs to activate a
photo-sensitive compound therapeutically, as well as other uses and
aspects of its products, such as manufacturing methods. The transaction
will eliminate LSO’s requirement to pay
licensing fees to LSLLC.
With all Litx™ intellectual property now in
hand, LSO is armed with strong non-oncology assets which it intends to
separately fund or spin out.
Working solely in the field of oncology to date, LSO has built a strong
development organization with a small, efficient team overseeing
engineering, clinical trials, manufacturing, and regulatory/legal
affairs. The company has designed a low-cost, single-use disposable
light-delivery unit that is intended to provide easy use for physicians
and tolerable, effective, and repeatable treatments for patients. LSO is
currently conducting late-stage clinical trials in metastatic colorectal
cancer (MCRC) and hepatocellular carcinoma (HCC), and has initiated a
Phase II clinical study in glioma.
PROPRIETARY TECHNOLOGY
Litx™ uses light-emitting diodes (LEDs) to
activate the proprietary photoreactive drug LS11 (talaporfin sodium).
Light-activated LS11 causes the production of singlet oxygen molecules
that kill diseased cells with minimum side effects through “programmed
cell death,” or apoptosis, and vascular
closure. It avoids the serious toxicities associated with conventional
cancer treatments.
Although designed to work seamlessly with standard regimens, Litx™
attacks tumors in unique ways. It kills tumors from the inside-out,
rather than outside-in, the method used in many standard treatments. Litx™
kills all tumor cells in a prescribed “kill
zone” around the LED bar, rather than only
the tiny minority of cells undergoing rapid division. Inducing cell
apoptosis rather than necrosis, Litx™ does
not promote tumor re-growth, inflammation, and resistance to treatment.
Multiple light sources and multiple treatments are feasible and can be
tailored based on the size, shape and location of the target tumor.
LSO’s light-delivery unit drives a tiny bar
of LEDs at the end of a very narrow, flexible connecting tube. After
injecting LS11 intravenously, administering physicians insert the bar
into a tumor with a biopsy-like procedure requiring only a local
anesthetic. Emitting red light at a discrete frequency, intensity, and
time period, the unit activates LS11 in the “kill
zone.” Unlike laser-based light-activated
therapies, Litx™ does not require expensive
equipment.
LSO MARKETS AND CLINICAL STRATEGY
Despite decades of research targeting solid tumors, those cancers
continue to confound the best efforts at treatment. The worldwide
incidence of colorectal cancer is approximately one million cases per
year. The National Cancer Institute reports that approximately 50% of
patients diagnosed with colorectal cancer will suffer from advanced
disease that has metastasized to other parts of the body, most commonly
to the liver. HCC is even more challenging. This primary liver tumor
kills over 1 million people worldwide per year. Current cancer treatments—surgery,
radiation therapy, chemotherapy, and other local ablative therapies—have
significant shortcomings, such as high toxicity, limited efficacy, tumor
re-growth and resistance, high set-up and usage costs, complicated
administration, and poor patient quality-of-life. Litx™
seeks to address all of those disadvantages.
Preclinical, Phase I, and Phase II data support the safety profile of
Litx™. As a result, the company is currently
conducting Phase III clinical trials in HCC and MCRC to demonstrate the
full extent of the Litx™ system’s
safety and efficacy.
LSO does not perceive Litx™ as a cure for
cancer. Instead the company believes the Litx™
technology should fit into the emerging paradigm for treating cancer as
a chronic, albeit life-threatening disease, with the aim of extending
patients’ lives and preserving quality of
life. Limiting costs, easing administration, and increasing tolerability
advance that overall strategy.
PORTFOLIO POTENTIAL
Based on the mechanism of action and the effect of Litx™
treatment, obvious targets of Litx™ also
include benign neoplasms—growths of
non-cancerous tissue that nonetheless have profound implications for
patient morbidity and even mortality. Using light-activated devices
based on those used in LSO’s cancer
treatments, Litx™ may offer new treatments in
vascular disease and benign prostatic hyperplasia (BPH).
In vascular disease, a Litx™ array is
designed to “recondition”
blood vessels by destroying any resident “vulnerable”
or unstable plaque. Such reconditioning of vessels may prevent rigidity
and narrowing—or stenosis—of
vessels and reduce the risk of breakup of plaque causing heart attack or
stroke. Preclinical data shows that Litx™
only affects diseased areas, leaving treated vessels reconditioned with
a favorable effect on the development of plaque or scar tissue. Litx™
may address BPH by shrinking the prostate gland in the same way it
shrinks tumors—by forcing apoptosis in
overgrown tissue. As in cancer, Litx™
advantages over existing therapies in BPH include treatment simplicity,
safety and repeatability using a disposable device.
LSO has now positioned itself for growth as a fully integrated
development company with a strong portfolio of intellectual property, an
advantageous technology platform, innovative products in development,
and an exceptionally talented team.