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Biotech Biz Alert: California Stem Cell Agency Altering Loan Policies

Posted: May 13, 2012 at 3:58 pm


The California stem cell agency is in
the midst of making significant changes in its lending regulations,
but says it is not part of an effort to transfer a $25 million loan
to Geron to another company.
That does not mean, however, that the agency is not going to
transfer the loan at some point. CIRM says it already has the
authority to do so.
Talk has surfaced from time to time at
CIRM meetings about the likelihood of helping to continue with the
hESC clinical trial that Geron abruptly abandoned last fall. The
surprise termination of Geron's hESC program came only a few months
after CIRM and Geron signed a $25 million loan agreement in August.
Geron is trying to sell off its hESC business, although Geron's hESC
team has already left the company, according to industry reports.
Modification of the CIRM loan
regulations has been underway for some time. Tomorrow the CIRM
directors' Intellectual Property and Industry Subcommittee will consider the latest proposals.
Some of the changes deal with
relinquishment and transfer of loans. The modifications explicitly
give CIRM President Alan Trounson the ability to transfer a loan
without having to go through additional reviews or seek board
approval. Other changes are also designed to clarify and remove
ambiguities in the transfer arrangement, which may well be necessary
in order to make a transfer acceptable to a buyer of the Geron
assets.
Geron paid off the loan last fall but
it is not clear whether that action would preclude a transfer. At one
point earlier this year, Trounson said he was involved in helping to find a buyer, but it is not clear whether any CIRM official is
currently involved. Geron has hired  Stifel
Nicolaus & Co. to help peddle
the hESC business.
CIRM's loan changes are complex. The
agency has not yet put together in one place a straightforward
rationale and explanation of all the modifications. Nonetheless,
biotech and stem cell firms should pay close attention to the
proposals. They could mean the difference between the infusion or
loss of millions for a company's research.
The proposals are expected to go before
the full CIRM board later this month. Then they will be subject to
the state's administrative law process, including a period for public
comment.
Tomorrow's meeting has public
teleconference locations in San Francisco, Los Angeles, La Jolla and
two in Irvine. Specific addresses can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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Advisor to CIRM Nominated to Board of CIRM Grant Recipient Expecting $5 Million from Agency

Posted: May 13, 2012 at 3:58 pm


A "special
advisor" to the $3 billion California stem cell agency has been nominated to the board of directors of Sangamo BioSciences, Inc., a
firm that is sharing in a $14.5 million grant from the state research
enterprise.
She is Saira Ramasastry, managing partner of Life Sciences Advisory, LLC, of
Emerald Lake Hills, Ca., and who also has worked as a consultant to
Sangamo. Ramasastry's ties to CIRM go back to at least May of 2010,
when she served as a consultant for the panel that CIRM hired to
review its operations. The panel strongly recommended that CIRM
engage industry more warmly. Since then Ramasastry's contracts with
CIRM have totalled $65,000. Her current $25,000 contract describes
her work for CIRM as "industry analysis and consultation."
Ramasastry's
website says she serves as "a special advisor to CIRM in
industry engagement initiatives and strategic projects." Her
firm also offers expertise to life sciences firms in "strategic
alternatives advisory, strategic options analysis, tailored business
development solutions and innovative financing strategies."
In a news release April 30 announcing her nomination, Sangamo said Ramasastry has worked as a consultant to the Richmond, Ca., company. William Ringo, chairman of Sangamo's board of
directors, said,

 "Saira's
extensive experience in global healthcare investment banking and
strategic advisory consulting will bring valuable financial,
commercial assessment and business development skills to our board."

Compensation for Sangamo directors in 2011 ranged from $75,000 to $35,000 for those who served a full year plus stock options. 

Sangamo is sharing
in a $14.5 million, four-year grant from CIRM with the City of Hope
in Los Angeles dealing with an AIDS- related lymphoma therapy. The
grant was approved in 2009. Sangamo expects to receive $5.2 million from the grant if it runs for the full four years. As of the end of 2011, the firm has received $2.4 million, according to its financial documents. In March, Ellen Feigal, CIRM senior vice
president for research and development, said the effort is due for an
evaluation late this year.  Earlier this year, CIRM terminated one $19 million grant in the same round after it failed to meet milestones.

Sangamo's board is
scheduled to vote on Ramasastry's nomination on June 21. 
The California
Stem Cell Report has asked Ramasastry if she has any comment for
publication. We are also querying CIRM and Sangamo. Their comments
will be carried verbatim when we receive them.
Our take?
Ramasastry's consulting work with both CIRM and Sangamo demonstrates
again the tiny size of the world of stem cell science. It also raises
questions about conflicts of interest involving CIRM and industry. Can
a consultant in such a position serve two masters and serve them both
equally well? CIRM's interests are not necessarily the same as
Sangamo's, which is a publicly traded firm working diligently to
generate profit and financial returns for its shareholders. To do
that, it needs capital from its financial "backers,"
including CIRM. The stem cell agency, however, is in the business of
getting the results that it wants from Sangamo. If not, the grant
can be cancelled. Working for both the stem cell agency, whose
paramount obligation is to the people of California, and a recipient
of the agency's millions is incompatible.

Source:
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Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

Posted: May 13, 2012 at 11:14 am

Editor's Choice Main Category: Ear, Nose and Throat Also Included In: Radiology / Nuclear Medicine;Cancer / Oncology;Stem Cell Research Article Date: 11 May 2012 - 10:00 PDT

Current Article Ratings:

The researchers note this finding could enhance the quality of life of 500,000 individuals with head and neck cancer each year worldwide.

The team found that the stem cells needed for regenerating the parotid gland (the largest pair of salivary glands) were primarily located in the major ducts of the gland. According to the researchers, these cells could be easily avoided during radiotherapy or given a minimal radiation dose.

Dr. Peter van Luijk, a research associate at the University Medical Center Groningen, The Netherlands, explained:

Findings from the study were presented at the 31st conference of the European Society for Radiotherapy and Oncology (ESTRO31).

Dry mouth syndrome is a condition in which there is not enough saliva in the mouth. The condition can occur when the parotid gland stops functioning properly after radiation damage.

Symptoms of dry mouth syndrome include difficulty sleeping, eating, tooth decay or loss, and bad breath. These symptoms lead to poorer quality of life and difficulty working, as well as social isolation.

The majority of treatments to treat the condition and its consequences are insufficient and can cost hundreds or even thousands of Euros per patient each year.

Dr. van Luijk said:

Originally posted here:
Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

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Successful Stem Cell Differentiation Requires DNA Compaction

Posted: May 13, 2012 at 11:14 am

Newswise New research findings show that embryonic stem cells unable to fully compact the DNA inside them cannot complete their primary task: differentiation into specific cell types that give rise to the various types of tissues and structures in the body.

Researchers from the Georgia Institute of Technology and Emory University found that chromatin compaction is required for proper embryonic stem cell differentiation to occur. Chromatin, which is composed of histone proteins and DNA, packages DNA into a smaller volume so that it fits inside a cell.

A study published on May 10, 2012 in the journal PLoS Genetics found that embryonic stem cells lacking several histone H1 subtypes and exhibiting reduced chromatin compaction suffered from impaired differentiation under multiple scenarios and demonstrated inefficiency in silencing genes that must be suppressed to induce differentiation.

While researchers have observed that embryonic stem cells exhibit a relaxed, open chromatin structure and differentiated cells exhibit a compact chromatin structure, our study is the first to show that this compaction is not a mere consequence of the differentiation process but is instead a necessity for differentiation to proceed normally, said Yuhong Fan, an assistant professor in the Georgia Tech School of Biology.

Fan and Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, led the study with assistance from Georgia Tech graduate students Yunzhe Zhang and Kaixiang Cao, research technician Marissa Cooke, and postdoctoral fellow Shiraj Panjwani.

The work was supported by the National Institutes of Healths National Institute of General Medical Sciences (NIGMS), the National Science Foundation, a Georgia Cancer Coalition Distinguished Scholar Award, and a Johnson & Johnson/Georgia Tech Healthcare Innovation Award.

To investigate the impact of linker histones and chromatin folding on stem cell differentiation, the researchers used embryonic stem cells that lacked three subtypes of linker histone H1 -- H1c, H1d and H1e -- which is the structural protein that facilitates the folding of chromatin into a higher-order structure. They found that the expression levels of these H1 subtypes increased during embryonic stem cell differentiation, and embryonic stem cells lacking these H1s resisted spontaneous differentiation for a prolonged time, showed impairment during embryoid body differentiation and were unsuccessful in forming a high-quality network of neural cells.

This study has uncovered a new, regulatory function for histone H1, a protein known mostly for its role as a structural component of chromosomes, said Anthony Carter, who oversees epigenetics grants at NIGMS. By showing that H1 plays a part in controlling genes that direct embryonic stem cell differentiation, the study expands our understanding of H1s function and offers valuable new insights into the cellular processes that induce stem cells to change into specific cell types.

During spontaneous differentiation, the majority of the H1 triple-knockout embryonic stem cells studied by the researchers retained a tightly packed colony structure typical of undifferentiated cells and expressed high levels of Oct4 for a prolonged time. Oct4 is a pluripotency gene that maintains an embryonic stem cells ability to self-renew and must be suppressed to induce differentiation.

H1 depletion impaired the suppression of the Oct4 and Nanog pluripotency genes, suggesting a novel mechanistic link by which H1 and chromatin compaction may mediate pluripotent stem cell differentiation by contributing to the epigenetic silencing of pluripotency genes, explained Fan. While a significant reduction in H1 levels does not interfere with embryonic stem cell self-renewal, it appears to impair differentiation.

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Successful Stem Cell Differentiation Requires DNA Compaction

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Successful stem cell differentiation requires DNA compaction, study finds

Posted: May 13, 2012 at 11:14 am

ScienceDaily (May 11, 2012) New research findings show that embryonic stem cells unable to fully compact the DNA inside them cannot complete their primary task: differentiation into specific cell types that give rise to the various types of tissues and structures in the body.

Researchers from the Georgia Institute of Technology and Emory University found that chromatin compaction is required for proper embryonic stem cell differentiation to occur. Chromatin, which is composed of histone proteins and DNA, packages DNA into a smaller volume so that it fits inside a cell.

A study published on May 10, 2012 in the journal PLoS Genetics found that embryonic stem cells lacking several histone H1 subtypes and exhibiting reduced chromatin compaction suffered from impaired differentiation under multiple scenarios and demonstrated inefficiency in silencing genes that must be suppressed to induce differentiation.

"While researchers have observed that embryonic stem cells exhibit a relaxed, open chromatin structure and differentiated cells exhibit a compact chromatin structure, our study is the first to show that this compaction is not a mere consequence of the differentiation process but is instead a necessity for differentiation to proceed normally," said Yuhong Fan, an assistant professor in the Georgia Tech School of Biology.

Fan and Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, led the study with assistance from Georgia Tech graduate students Yunzhe Zhang and Kaixiang Cao, research technician Marissa Cooke, and postdoctoral fellow Shiraj Panjwani.

The work was supported by the National Institutes of Health's National Institute of General Medical Sciences (NIGMS), the National Science Foundation, a Georgia Cancer Coalition Distinguished Scholar Award, and a Johnson & Johnson/Georgia Tech Healthcare Innovation Award.

To investigate the impact of linker histones and chromatin folding on stem cell differentiation, the researchers used embryonic stem cells that lacked three subtypes of linker histone H1 -- H1c, H1d and H1e -- which is the structural protein that facilitates the folding of chromatin into a higher-order structure. They found that the expression levels of these H1 subtypes increased during embryonic stem cell differentiation, and embryonic stem cells lacking these H1s resisted spontaneous differentiation for a prolonged time, showed impairment during embryoid body differentiation and were unsuccessful in forming a high-quality network of neural cells.

"This study has uncovered a new, regulatory function for histone H1, a protein known mostly for its role as a structural component of chromosomes," said Anthony Carter, who oversees epigenetics grants at NIGMS. "By showing that H1 plays a part in controlling genes that direct embryonic stem cell differentiation, the study expands our understanding of H1's function and offers valuable new insights into the cellular processes that induce stem cells to change into specific cell types."

During spontaneous differentiation, the majority of the H1 triple-knockout embryonic stem cells studied by the researchers retained a tightly packed colony structure typical of undifferentiated cells and expressed high levels of Oct4 for a prolonged time. Oct4 is a pluripotency gene that maintains an embryonic stem cell's ability to self-renew and must be suppressed to induce differentiation.

"H1 depletion impaired the suppression of the Oct4 and Nanog pluripotency genes, suggesting a novel mechanistic link by which H1 and chromatin compaction may mediate pluripotent stem cell differentiation by contributing to the epigenetic silencing of pluripotency genes," explained Fan. "While a significant reduction in H1 levels does not interfere with embryonic stem cell self-renewal, it appears to impair differentiation."

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Successful stem cell differentiation requires DNA compaction, study finds

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In The Know: Stem cell therapy

Posted: May 13, 2012 at 11:14 am

Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

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In The Know: Stem cell therapy

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

Posted: May 13, 2012 at 5:14 am

By Cathy C. Yamsuan Philippine Daily Inquirer

Former President Joseph Erap Estrada had always maintained that giving generously to friends and forgiving opponents are the secrets to staying young.

But time has a way of catching up with even the most formidable leading men.

Since he entered national politics 25 years ago, Estrada has struggled with the attributes of old ageweight gain, a painful knee here, a cataract there.

He needed some kind of elixir of youth to put to right what nature has put asunder. And to get back on his feet in time to serve the people, he said which has no age limit.

So he did it, and is very open about it. What is it?

At the prodding of friends, the 75-year-old Estrada flew to Frankfurt, Germany, last month to undergo fresh cell therapy (also known as stem cell treatment), an innovative albeit controversial procedure where fresh cells from donor animals are injected into the human body to treat diseases or reverse the aging process.

Fresh cell therapy operates under the principle of like heals like.

The fresh cells from a donor animals organ are infused into the human counterpart.

Substances in the donors blood are supposed to reactivate the human bodys immune system and defense mechanism, a reaction that would eventually rebuild and revitalize aging tissues.

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Joseph Estrada defies age, shares how he did it: Stem cell therapy

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Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

Posted: May 13, 2012 at 5:14 am

Editor's Choice Main Category: Ear, Nose and Throat Also Included In: Radiology / Nuclear Medicine;Cancer / Oncology;Stem Cell Research Article Date: 11 May 2012 - 10:00 PDT

Current Article Ratings:

The researchers note this finding could enhance the quality of life of 500,000 individuals with head and neck cancer each year worldwide.

The team found that the stem cells needed for regenerating the parotid gland (the largest pair of salivary glands) were primarily located in the major ducts of the gland. According to the researchers, these cells could be easily avoided during radiotherapy or given a minimal radiation dose.

Dr. Peter van Luijk, a research associate at the University Medical Center Groningen, The Netherlands, explained:

Findings from the study were presented at the 31st conference of the European Society for Radiotherapy and Oncology (ESTRO31).

Dry mouth syndrome is a condition in which there is not enough saliva in the mouth. The condition can occur when the parotid gland stops functioning properly after radiation damage.

Symptoms of dry mouth syndrome include difficulty sleeping, eating, tooth decay or loss, and bad breath. These symptoms lead to poorer quality of life and difficulty working, as well as social isolation.

The majority of treatments to treat the condition and its consequences are insufficient and can cost hundreds or even thousands of Euros per patient each year.

Dr. van Luijk said:

Link:
Using Stem Cell Therapy For Neck And Head Cancers Avoids Salivary Gland Damage Caused By Radiotherapy

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Stem Cell Study Shows Promising Results Against Heart Failure

Posted: May 13, 2012 at 5:14 am

By Denise Mann HealthDay Reporter

THURSDAY, May 10 (HealthDay News) -- A new treatment that involves spinning bone marrow stem cells to enhance their healing potential may help people with advanced heart failure feel and function better, a small study suggests.

Researchers developed the treatment by culturing a patient's own bone marrow for 12 days. This process helped increase the amount of immune cells and stem cells that can differentiate into several different cell types, including heart cells. Those cells were then injected into heart muscle. The study was funded by treatment manufacturer Aastrom Biosciences.

According to the findings, this treatment was safe, helped repair the damaged heart muscle and reversed some heart failure symptoms, when compared to a placebo injection. The findings were to be presented Thursday at the Society for Cardiovascular Angiography and Interventions annual meeting, in Las Vegas.

The U.S. National Heart, Lung, and Blood Institute reports that about 5.8 million people in the United States have heart failure, a condition that occurs when the heart can no longer pump enough blood to meet the body's needs. Symptoms include shortness of breath, fatigue and swelling in the ankles, feet, legs and abdomen. There is no cure; treatment typically includes a cocktail of medications aimed at reducing symptoms and improving quality of life.

"A number of people with heart failure have slowly progressing disease despite medication and/or device therapy. If we could have a therapy for this group that would slow the progression of heart failure, it would be economic and change the disease process tremendously," said study author Dr. Timothy Henry, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis. The treatment would not be used for people who need a heart transplant.

Calling it the next generation of stem cell therapy, Henry said the treatment process helps enhance the potency of existing stem cells. "It gives a more functional product," and when injected these stem cells may promote the growth of new blood vessels, he added.

Further study is ongoing, and if the results are positive a product could be available within two years to treat inadequate blood supply to the legs, and soon thereafter for heart failure, he said. According to Henry, six or seven new products that enhance bone marrow stem cells are being developed. "Ask your doctor if you are a candidate for any of the clinical trials," Henry advised.

The new study included 22 participants with advanced heart failure and an enlarged heart whose current medication regimen was no longer effective. They either received an injection of the stem cell therapy treatment into their heart muscles or a placebo shot. After 12 months, there were no complications and no difference in side effects among those who received the stem cells and the control group. That said, individuals who received the novel stem cell therapy did have a lower number of major heart-related events and were more likely to see improvements in their ability to walk without growing breathless. Those who received the stem cell treatment also showed marked improvements in their ejection fraction, which is a measure of how much blood leaves the heart with each pump.

"This study tells us that injecting stem cells into the heart muscle of a patient with chronic heart failure may be beneficial," says Dr. Sandeep Jauhar, director of the congestive heart failure program at Long Island Jewish Medical Center in New Hyde Park, N.Y. Typically, these individuals are treated with multiple medications, put on a low-salt diet and encouraged to get some exercise.

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Stem cells jab ‘helps brain cancer patients tolerate chemotherapy’

Posted: May 11, 2012 at 6:14 pm

By Daily Mail Reporter

PUBLISHED: 16:01 EST, 9 May 2012 | UPDATED: 01:37 EST, 10 May 2012

Stem cells have been transplanted into brain cancer patients for the first time in a bid to protect them against the toxic side effects of chemotherapy.

In a study involving three patients, scientists found that two of them survived longer than predicted following the surgery while the other has seen no disease progression after three years of treatment.

The study was carried out by the Fred Hutchinson Cancer Research Centre in the United States.

Breakthrough: Scientists have transferred stem cells into brain cancer sufferers in a bid to protect them against the harmful effects of chemotherapy

The centre's Dr Hans-Peter Kiem said: 'We found that patients were able to tolerate the chemotherapy better and without negative side effects after transplantation of the gene-modified stem cells.

'This compares with patients in previous studies who received the same type of chemotherapy without a transplant of gene-modified stem cells.'

Dr Kiem added that a major barrier to effective use of chemotherapy to treat cancers such as glioblastoma, which all three patients had, has been the toxicity of chemotherapy drugs to other organs, primarily bone marrow.

This results in decreased blood cell counts, increased susceptibility to infections and other side effects.

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