NeoStem NBS, a leader in the emerging cellular therapy market,
continues to position itself for success through scientific discovery, a
diversified product development pipeline that addresses cardiovascular and
autoimmune diseases as well as regenerative medicine, an expanding contract
development and manufacturing business that serves as its revenue generating
arm, and a professional and experienced management team.
We are proud to be at the forefront of a paradigm shift in medicine toward
cell therapy – a shift away from treating disease with drugs and toward
treating disease with our own cells; a shift away from treating symptoms and
toward cures for illnesses that cause the most suffering; a shift away from
chemical drug development and toward looking inside ourselves to understand
and then amplify our bodies' natural repair mechanism. We firmly believe that
the future of medicine emanates from within each of us and NeoStem is
dedicated to unlocking the potential of cellular therapy for humankind.
NeoStem prides itself on not being "just another biotech company." In the
ever-changing global economy, ingenuity is rewarded. We are building the
Company based on the foundation and sector expertise provided by our contract
development and manufacturing subsidiary, Progenitor Cell Therapy ("PCT"). As
a leader in the cell therapy industry in-process development innovation and
cost effective scale-up, PCT supports NeoStem's internal development of its
therapeutic programs. Our investments in our therapeutic pipeline, which we
have approached with scientific discipline and business and market analysis,
include significant opportunities which are protected by an expanding
intellectual property portfolio, positioning the Company for dynamic partner
collaborations.
As more cellular therapies enter clinical trials and therapies start to become
commercially available, scores of scientists, doctors and patients are
awakening to a simple reality – cell therapies hold the potential to vanquish
a plethora of diseases and dangerous medical conditions. NeoStem is dedicated
to its leadership role in cellular therapy and we look forward to an amazing
future built on the accomplishments of today.
We have been extremely busy and productive at NeoStem as we continue to
implement our Company's strategic growth and development plans, all the while
never losing sight of our responsibility to the health and wellness of the
public. Our pipeline of proprietary cell therapy products continues to develop
and, most notably, we are on track to complete enrollment of our PreSERVE
Phase 2 clinical trial this year, investigating the Company's most advanced
product candidate, AMR-001, in preserving heart function after a severe heart
attack, with data read out 6-8 months after the last patient is infused. PCT
continues to strengthen its presence in the contract development and
manufacturing arena. And lastly, our Company has undergone a positive
corporate change by moving our stock listing to NASDAQ intended to make us
more competitive in the marketplace and enhance exposure to institutional
shareholders, while at the same time providing investors with the best prices,
the fastest execution and lowest cost per trade.
Finally, our search for the brightest talent to make our Company the "best in
class" has brought us experienced industry executives that we believe will
assist in maximizing shareholder value. We have recently added four new key
members to our management team – each a seasoned executive in the field –
raising the Company's profile in the industry, increasing our core knowledge
and skill base, and increasing our competitiveness amongst our peers. The team
members include Dr. Douglas Losordo, Chief Medical Officer; Robert Dickey IV,
Chief Financial Officer; Stephen W. Potter, Executive Vice President; and
Robert Shaw, Vice President of Commercial Sales, PCT.
I'd like to share details on some of our recent highlights and developments.
CLINICAL AND DEVELOPMENT UPDATES
NeoStem continues to advance its research and development efforts. Our
proprietary product development pipeline targets unmet medical needs in
conditions such as cardiovascular disease (acute myocardial infarction,
congestive heart failure, and traumatic brain injury), immune disorders (type
1 diabetes, steroid resistant asthma, and organ rejection) and tissue repair
(periodontitis, wound healing, osteoporosis, macular degeneration, acute
radiation syndrome, and other indications).
The following are some of the important collaborations and updates in the
Company's research and development:
Amorcyte
We are very excited and encouraged by the enrollment progress of the PreSERVE
Phase 2 clinical trial, investigating the Company's most advanced product
candidate, AMR-001, in preserving heart function after a severe heart attack.
We are on track to complete patient enrollment for this trial in 2013 with
data read out 6-8 months after the last patient is infused.
The Amorcyte intellectual property portfolio continues to grow and AMR-001 now
has the benefit of 4 granted U.S patents, 8 patent grants outside of the U.S.
and 24 additional patents pending around the world. We are beginning the
process of expanding applications for AMR-001 into other ischemic conditions
such as congestive heart failure and traumatic brain injury.
Athelos
Human Regulatory T cells ("Treg") therapy represents a novel approach for
restoring immune balance by enhancing T-regulatory cell number and function.
NeoStem continues to advance its T cell program with the goal of developing
treatments for immune-mediated diseases such as type 1 diabetes, and
inflammatory conditions such as steroid resistant asthma.
In July, the Company executed agreements with the University of California,
San Francisco ("UCSF") and the laboratories of Jeffrey Bluestone, PhD, and
Qizhi Tang, PhD, to collaborate on the development of a therapy for the
treatment of type 1 diabetes. This collaboration will advance the Company's
Treg program towards a Phase 2 trial to evaluate the efficacy of autologous
Tregs in type 1 diabetes, effectively advancing the Company's pipeline more
quickly than if it had developed a program for this clinical indication
independently. Under the agreements, NeoStem will manufacture a Treg product
consisting of polyclonally expanded Tregs for the planned Phase 2 trial to
treat patients newly diagnosed with type 1 diabetes and will also collaborate
with Dr. Bluestone on allo-specific Tregs for organ transplant tolerance in
another anticipated clinical study. The collaboration also includes the
research effort to develop the next generation of Treg products for
therapeutic use.
In August, we engaged the services of three experts at the forefront of asthma
research, William Busse, M.D., of the University of Wisconsin; Mario Castro,
M.D., M.P.H, of the Washington University in St Louis; and Prescott Woodruff,
M.D., M.P.H., of the University of California, San Francisco. Each of the
consultants brings a breadth of experience in research to assist the Company
in determining the appropriate clinical endpoints for a clinical trial in
steroid resistant asthma.
In September, the Company announced the licensing of three families of patents
from UCSF. NeoStem's worldwide exclusive license to these patents provides
incremental protection for the Company's Treg platform. The three patent
families cover methods to isolate, expand and use Tregs with therapeutic
potential for autoimmune disorders, including U.S. patent 7,722,862, which
claims a cellular immunotherapy for the treatment of type 1 diabetes.
NeoStem's patent estate for its Treg program now includes exclusive rights to
22 issued patents in U.S. and major international commercial geographies and
covers isolation, activation, expansion and methods of treating or preventing
certain conditions and/or diseases using Tregs.
VSEL™ Technology
We continue to develop our very small embryonic like stem cell (VSEL^TM
Technology) platform in pre-clinical models and expect soon to advance into
early clinical studies that assess the therapeutic potential of VSEL^TM
Technology in wound care, bone regeneration and/or macular restoration.
NeoStem also continues to receive grant awards to develop this important
technology, including a recent award of funds from the National Institute of
Allergy and Infectious Diseases (NIAID) supporting the development of VSEL^TM
Technology for radiation exposure.
Recent pre-clinical data in animal models suggest that VSELs™ may be capable
of developing into cells of all three germ layers which, if substantiated by
further research, could imply significant potential for restorative healing.
Unlike classically defined "pluripotent" stem cells, it is believed that
VSELs™ do not contribute to teratoma formation. Independent investigators in
preclinical models have demonstrated the regenerative potential of VSELs™ and
we will continue to support preclinical and early clinical studies to further
assess the regenerative potential of VSEL™ Technology.
PROGENITOR CELL THERAPY
NeoStem is capitalizing on the dramatic growth in the cell therapy industry
both for its clients and for its internal pipeline by vertically integrating
the collection, storage and processing of cellular material and by developing,
manufacturing, distributing, and delivering cell therapy products.
PCT has built a strong foundation of services that cater to the entire
industry and offers NeoStem and PCT clients cell processing and development
capabilities on both the East and West Coasts of the U.S. PCT is also pursuing
plans to expand internationally. PCT currently provides services to over 30
clients and is the only contract development and manufacturing organization
("CDMO") to have worked with a client's product (Provenge®) through all of the
phases of clinical trials and ultimately to FDA approval.
PCT completed three process development contracts in Q2 2013, triggering
higher revenue recognition. PCT also recently signed two new clients,
including a large pharmaceutical company that is entering the cell therapy
sector. PCT's management team is focused on growing the CDMO business through
increased services and product offerings, including automation technologies
geared toward improving efficiencies and lowering cost of goods.
PCT's business model uniquely positions NeoStem to take advantage of revenues
generated in a growing industry, while reducing its reliance on the success of
NeoStem's internal development platforms. This unique revenue-generating CDMO
business allows NeoStem to remain current on the most innovative developments
in the sector, informing our decisions as we seek to co-develop and/or acquire
new technologies.
As the regenerative medicine market continues to grow, NeoStem is uniquely
positioned to capture the value of this market and lead the industry. We
appreciate your continued confidence in the Company's agenda and will continue
to provide updates on our progress as we work to save lives and end suffering
for the millions of people afflicted with chronic disease.
Regards,
Robin L Smith, M.D., MBA
Chairman and Chief Executive Officer
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