Tag Archives: NIH

NeoStem’s CEO, Dr. Robin L. Smith, Letter to Shareholders

NEW YORK , Jan. 3, 2012 /PRNewswire/ —

Dear NeoStem Shareholders,

We would like to take a moment to both look back at 2011 – a transformative year for NeoStem (NYSE Amex: NBS) – and to look ahead to near term catalysts that we expect to move the company forward in 2012 and beyond.

We have closed two acquisitions – Progenitor Cell Therapy, LLC (“PCT”) and Amorcyte, LLC (“Amorcyte”).

We believe our therapeutic product development team is very close to accomplishing its aggressive goal of getting a first patient enrolled in our AMR-001 Phase 2 clinical trial for the treatment of AMI with the clinical sites beginning to open.  This brings us closer to achieving our goal of enrollment of the targeted 160 patients in the study over the next year or so with first data follow-up six months after the last patient is enrolled (roughly mid-2013).

Our cell therapy manufacturing business is growing and client satisfaction confirms our belief and excitement that we have unique skills and people (expertise, quality and work ethic) to serve as a platform to be a global leader in the cell therapy space.

We raised $16.5 million in gross proceeds in 2011 for working capital, including research and development of our cell therapeutic candidates.

We received awards of over $1.7 million in Department of Defense funding for development of our VSELTM Technology to treat osteoporosis and $245,176 from the National Institutes of Health (NIH) with Excell Therapeutics to progress our T regulatory program in Lupus.

We co-hosted a spectacular international conference in partnership with the Vatican’s Pontifical Council for Culture on Adult Stem Cells: Science and the Future of Man and Culture, moving forward the public discussion of adult stem cells and adult stem cell research.

Our cord blood banking enrollment more than doubled over the previous year.

We have been marketing our ownership in Suzhou Erye Pharmaceutical Co. Ltd. subsidiary for possible sale.

We have positioned our intellectual property portfolio to expand beyond the current indications and give us a strong position in the cell therapy arena.

We continue to make great headway in integrating IT systems, legal, finance, and marketing for our multiple entities to achieve cost savings and maximize efficiencies.

NeoStem gained a significant pharmaceutical partnership with Becton Dickinson through our co-ownership of Athelos, Inc. (80% NeoStem, 20% BD). We are actively pursuing additional strategic relationships with major pharmaceutical and biotechnology companies in 2012.

We look forward to keeping you updated and encourage your questions via the contact information below. I also encourage you to learn more by visiting our company websites, www.neostem.com, www.amorcyte.com, and www.progenitorcelltherapy.com, our social media outlets, and our company blog at thechairmansblog.com/robin-l-smith. Thank you for your continued support of NeoStem and our ongoing transformation.

Sincerely,

Dr. Robin L. Smith
Chairman and CEO

About NeoStem, Inc.
NeoStem, Inc. (“NeoStem”) is a leader in the development and manufacture of cell therapies. NeoStem has a strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. That manufacturing base is one of the few cGMP facilities available for contracting in the burgeoning cell therapy industry, and it is the combination of PCT’s core expertise in manufacturing and NeoStem’s extensive research capabilities that positions the company as a leader in cell therapy development. Amorcyte, Inc., also a NeoStem company, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte’s lead compound, AMR-001, represents NeoStem’s most clinically advanced therapeutic, poised to commence enrollment of patients in a Phase 2 trial for the preservation of heart function after a heart attack.  Athelos Corporation, also a NeoStem company, is developing a T-cell therapy for a range of autoimmune conditions with our partner Becton-Dickinson.  NeoStem’s pre-clinical assets include its VSEL™ Technology platform for regenerative medicine, which NeoStem believes is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today.

Official definition of human embryonic stem cells widened in US

By Dr Philippa Brice, PHGFoundation.org

The official definition of human embryonic stem (HES) cells in US National Institutes of Health (NIH) guidelines is to be broadened from those ‘derived from the inner cell mass of blastocyst stage human embryo’ (ie. from embryos that have reached the blastocyst stage at four or five days old, 70-100 cells), to include also those derived from earlier stage embryos.

Dr Lana Skirboll, director of the Office of Science Policy of the NIH, reportedly said: “We are making what I think is a relatively small technical change to the definition of human embryonic stem cells…This changes none of the ethical requirements in the guidelines” (see Reuters news). This move was prompted by an application from a commercial source to list cell lines derived from eight-cell stage embryos, and will make some commercial and academic research programs potentially eligible for government funding.

Derivation of HES cells from a cell taken from an eight-cell stage embryo could possibly allow implantation and normal development of the remaining seven-cell embryo. This is what happens in pre-implantation prenatal diagnosis (PGD); one cell is removed for genetic analysis and, if healthy, the seven-cell embryo is implanted and can grow into a normal fetus.

New human embryonic stem cell lines eligible for federal research dollars for the first time since 2001

By Karen Kaplan,  LATimes.com

The number of human embryonic stem cell lines eligible to be used in government-funded research just went up by 13.

The National Institutes of Health announced today that 11 new cell lines from Dr. George Daley at Children’s Hospital Boston and two lines from Ali Brivanlou at Rockefeller University in New York became the first additions to the NIH Human Embryonic Stem Cell Registry since President Obama reversed his predecessor’s policy. Under President Bush, only human embryonic stem cells prior to August 2001 were eligible for federal funding.

The new lines were derived from embryos created for fertility treatments and donated by couples who went through a rigorous informed consent process.

And more may be on the way. The NIH said that 96 more lines have been submitted by researchers, including 20 that will be vetted by an advisory committee on Friday.

The additions come nearly nine months after Obama signed an executive order that directed the NIH to make federal research funds available to newer lines of human embryonic stem cells. Scientists were overjoyed and said the decision would accelerate the pace of research into such ailments as diabetes, Alzheimer’s and spinal cord injuries. Details of the policy are available here.

Obama Issues Executive Order To Lift Some Federal Restrictions On Embryonic Stem Cell Research

President Obama on Monday at an event with Democratic and Republican lawmakers is expected to announce that he will reverse restrictions put in place by former President George W. Bush on federal funding for embryonic stem cell research, in keeping with campaign promises to “separate science and politics,” the New York Times reports. Although the decision to reverse the restrictions is “not surprising,” it is “nonetheless of great interest, involving a long-controversial intersection of science and personal moral beliefs,” the Times reports (Stout/Harris, New York Times, 3/7). According to the Washington Post, Bush imposed restrictions in August 2001 that limited federal funding to studies involving stem cell lines that were already in existence — about 21 lines. By lifting the restrictions, Obama will “allow thousands of scientists to study hundreds” of stem cell lines that have been developed during the last eight years, the Post reports. Researchers also will be able to “dismantle cumbersome bureaucracies constructed to work around the constraints and let them exchange scientific ideas more easily,” the Post reports (Stein, Washington Post, 3/7).

Obama’s announcement that he intends to lift the restrictions “is not likely to lead to any immediate change in government policy,” the Times reports. It may take many months for NIH to develop new guidelines for the research, but advocates are expected “to push for the process to go as quickly as possible” so universities can have adequate time to submit grant proposals before September 2010, when NIH must give out the last of the $10.4 billion allotted to the agency in the economic stimulus law.

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