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Biopharma Will Need More than New Law to Embrace Crowdfunding – Genetic Engineering News

By Dr. Matthew Watson


Genetic Engineering News
Biopharma Will Need More than New Law to Embrace Crowdfunding
Genetic Engineering News
Genetic Engineering & Biotechnology News (GEN) has retained its position as the most widely read biotechnology publication around the globe since its launch in 1981. Published 21 times a year and with additional exclusive editorial content online, ...

and more »

Source:
http://news.google.com/news?q=genetic-engineering&output=rss

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Iona Prep AP Biology Class Visits DNA Learning Center in Cold Spring Harbor – Talk of the Sound

By Dr. Matthew Watson


Talk of the Sound
Iona Prep AP Biology Class Visits DNA Learning Center in Cold Spring Harbor
Talk of the Sound
By Talk of the Sou... on Tue, 03/06/2012 - 22:56 Iona Prep's AP biology class recently visited the DNA Learning Center in Cold Spring Harbor to perform a molecular genetics laboratory exercise called DNA Restriction Analysis. On Wednesday, February 29, ...

Source:
http://news.google.com/news?q=molecular-genetics&output=rss

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Key to Making Egg Cells Mature Found, Researchers Say – MyHealthNewsDaily

By Dr. Matthew Watson


MyHealthNewsDaily
Key to Making Egg Cells Mature Found, Researchers Say
MyHealthNewsDaily
24 in the journal Human Molecular Genetics. Pass it on: By studying a protein called cdk1, researchers may gain a better insight into some cases of infertility in women. Follow MyHealthNewsDaily on Twitter @MyHealth_MHND. Find us on Facebook. woman ...
Discovery of a molecule that initiates maturation of mammalian eggs can lead ...Science Daily (press release)

all 6 news articles »

Source:
http://news.google.com/news?q=molecular-genetics&output=rss

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Predicting the Success of the Late-Stage Cell-Based Cancer Immunotherapy Pipeline?

By Dr. Matthew Watson

Tweet 


Adam
Feuerstein
(phama and biotech writer with TheStreet.com) has designed his own rule. 

For those who know or follow Adam, this will come as no surprise.  He is
neither short of rules nor opinion and is never shy in his vivid expression of
either.  But this rule is more than a simple expression of informed
opinion. It was born of hard data analysis and has yet to be broken.  In
Adam’s own words, this is how he and his colleague (Mark J. Ratain) came to the
rule they coined the Feuerstein-Ratain Rule:
[We] analyzed the outcomes of
59 phase III clinical trials of cancer drugs going back 10 years, stratified by
the market value of the companies four months prior to trial results being
announced. What we found was a remarkable difference between the market values of companies that had positive and negative
announcements
.  (the list of companies/products used can be found here
)
Specifically, the median market capitalization was approximately
80-fold greater for the companies with positive trials vs. companies with
negative trials. There were no positive trials among the 21 micro-cap companies
(companies with less than $300 million market capitalization) whereas 21 of 27
studies reported by the larger companies analyzed (greater than $1 billion
capitalization) were positive.
The
editorial, entitled “Oncology Micro-Cap Stocks: Caveat Emptor!”, can be
found in Journal of the National Cancer
Institute
 
(JNCI) at http://jnci.oxfordjournals.org/content/early/2011/09/26/jnci.djr375.full.
They identified
drugs that were undergoing evaluation in phase III trials or for regulatory approval
by the US FDA between January 2000 and January 2009. 
They calculated the
company value based on the market value of primary drug sponsor roughly
three months prior to the release of the data.  They concluded that
whether or not a company had pharma in place was not determinative of a drug’s
success but rather that partnerships or acquisitions by Big Pharma can play a
role in determining a drug’s success only in that these deals may increase the
market value of the primary drug sponsor.  That value was the
determinative factor.
This
is Adam’s summary of the analysis they did that led to the “Feuerstein-Ratain Rule”.  
Below
are the important snippets from the analysis behind the rule:
The "Feuerstein-Ratain
rule" is derived from an analysis of 59 phase III clinical trials of
cancer drugs conducted over the past 10 years. We actually had no say
whatsoever in the selection of cancer drugs used in the analysis. The list was
put together by health economist Allan Detsky of Toronto's Mount Sinai Hospital
and his co-authors as part of their paper published in the Journal of the National Cancer
Institute
 suggesting that
doctors entrusted with conducting late-stage cancer drug clinical trials are
using advanced knowledge of the results of these pivotal studies to engage in
illegal insider trading.
Ratain and I used the same list of 59 cancer drug clinical trials,
re-analyzed by market value of the drug sponsors, to debunk Detsky's
insider-trading theory. That's how the "Feuerstein-Ratain rule" came
about, and we published our conclusions in the JNCI alongside Detsky's paper.
To restate our findings:  No positive trials among the
21 micro-cap companies
(companies with less than $300 million market
capitalization) whereas 21 of 27 studies reported by the larger companies analyzed
(greater than $1 billion capitalization) were positive
There were 21 companies on the
list with market values of $300 million or less, with a 0% success rate in
phase III cancer drug clinical trials.
The list also contained 11 companies with market caps between
$300 million and $1 billion. The clinical trial success rate for this mid-tier
or second strata group was 18%. (Two positive clinical trials out of 11.)
Lastly, there were 21 of 27 studies reported by the larger
companies analyzed (greater than $1 billion capitalization) that were positive,
or a 78% success rate.
So
what interesting for us in cell therapy?
It
is interesting to note that the Feuerstein-Ratain Rule is
limited to oncology drugs and all the companies behind them were public. 
Adam has not – nor has anyone else to the best of my knowledge – looked at how
the rule may or may not translate outside of oncology.

Of
the cell therapy companies to have received market approval in US or EU in the
past 10 years, one was public (DNDN) and one was still private (TIG) and went
public shortly therafter in the same year. TiGenix was a private company and is
not in oncology so the analysis arguably does not apply.  However,
Dendreon’s Provenge is an oncology ‘drug’.  Dendreon had a market cap of
about $430M in the 4 months before its ph III data was announced and as such
would have fallen in the 18% likelihood of success category.  That sounds
about right.

I thought it might be interesting to do our own look at what the Rule might say about the pipeline of late-stage cell-based oncology trials.  Following
is a list of cell therapy companies currently in ph III or II/III for oncology:

* Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.  It also could be
argued that this is not an oncology treatment as per original data set but a
treatment of the side  effects of the primary cancer treatment.
** Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.
*** It could be argued that this is not an
oncology treatment as per original data set but 
a treatment of the side effects of the primary cancer treatment.
+ It could be argued this is not a cell
therapy though we would argue it is.  Others might argue that as a phase II/III
trial with only 60 patients this may not be powered to be a pivotal oncology trial.
^ Trial currently in “suspension” so this
date may be pushed out or trial terminated. It also could be argued that this
is not an oncology treatment as per original data set but a treatment of
the effects of the primary cancer treatment.  Others might argue that as a phase II/III trial with
only 70 patients this may not be powered to be a pivotal oncology trial.
Conclusion:  At the moment it looks like both NovaRx and ERYtech will go to their phase III data completion (June and October 2012 respectively) as private companies.  To qualify under the rule, Cell Medica would have to go public within the year and/or Kiadis would have to go public within the next 25 months. 

The only
companies with cell-based oncology products currently in late-stage trials to
which the Rule would apply are Molmed’s HSV-TK and Newlink Genetics’ HyperAcute
Pancreas.  

Assuming both MolMed and NewLink's trials progress as planned, we won’t know what
they look like under the rule until around Sept 2013 at which time we can assess their
market cap against the Rule.  At the moment, it’s looking pretty bleak for
both of them according to the Rule though at least the NLNK price has been
going in the right direction of late.  

Certainly one would expect trading
volume to dramatically increase on both these as their trial completion dates
near.  It remains to be seen how this will impact price but they would
have to  dramatically increase in market cap (double or triple) to succeed
as the Rule predicts. 

Naturally, this is just one way of looking at the world and, of course, this rule - as with all rules - is meant to be broken.
  

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Can “Clinical Data Integration on the Cloud” be a reality?

By Dr. Matthew Watson

 

The story I am about to tell is almost 8 years old. I was managing software services delivery for a global pharmaceutical company from India. This was a very strategic account and the breadth of services covered diverse systems and geographies. It is very common that staff from the customer organization visit our delivery centers (offsite locations) to perform process audits, governance reviews and to meet people in their extended organizations.

During one such visit a senior executive noticed that two of my colleagues, sitting next to each other, supported their system (two different implementations of the same software) across two different geographies. They happened to have the name of the systems they support, pinned to a board at their desks. The executive wanted us to take a picture of the two cubicles and email to him. We were quite surprised at the request. Before moving on to speak to other people he asked a couple of questions and realized the guys were sharing each other’s experiences and leveraging the lessons learnt from one deployment for the other geography.  It turned out that this does not happen in their organization, in fact their internal teams hardly communicate as they are part of different business units and geographies

Read full article on at inPharmatics

Source:
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International Stem Cell Corporation to Present at the Roth Conference on March 14, 2012

By Dr. Matthew Watson

International Stem Cell Corporation (OTCBB:ISCO) today announced that Co-Chairman Kenneth Aldrich and President and Chief Operating Officer Kurt May will be presenting at the 24th Annual Roth Conference on Wednesday, March 14, 2012 at 1:00 p.m. Pacific time. The conference is being held March 11-14 at the Ritz Carlton Hotel in Dana Point, California.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
International Stem Cell Corporation
Kenneth C. Aldrich, Co-Chairman
760-940-6383

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

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Heart Disease Stem Cell Therapies – Development Must Come From Several Specialties

By LizaAVILA

Editor's Choice Academic Journal Main Category: Heart Disease Also Included In: Cardiovascular / Cardiology;Stem Cell Research Article Date: 09 Mar 2012 - 4:00 PST

email to a friend printer friendly opinions

Current Article Ratings:

5 (1 votes)

The paper's lead author, Kenneth Chien from Harvard University in the USA explains:

Until now, clinical trials have been based on heart attacks, chronic heart failure as well as dilated cardiomyopathy, but regardless of the fact that regenerative therapies that are based on various non-cardiac cell types seem to be safe, their efficacy has not yet been tested in a clinical trial.

However, possible new targets and treatment strategies are now emerging due to recent progress in cardiac stem cell research and regenerative biology.

Scientists used to think that the heart only has a minimal capacity for self-renewal and saw no prospect in reversing the loss of healthy heart muscle and function. This perception has been altered because of recent findings, such as the discovery of several distinct embryonic progenitor cell types of which some are found in the heart.

A certain number of these cells can be activated in people with cardiac injuries and are now targeted by scientists to develop novel cardiac regenerative therapeutics either by delivery of the cells, or by new methods that activate expansion and conversion of functioning heart cells.

For instance, clinical studies conducted a short while ago demonstrated that scar formation following a heart attack can be reduced by taking cells from the patient's own heart tissue. Even though it remains uncertain whether the delivered cells are indeed stem cells, these studies nevertheless demonstrate that this is a small, educational step towards the goal of utilizing the heart's potential for self-healing.

The rest is here:
Heart Disease Stem Cell Therapies - Development Must Come From Several Specialties

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Stem cells are my last hope. Can you help?

By Sykes24Tracey

Cancer sufferer Pamela Bou Sejean wants your help to save her life

Pamela Bou Sejean has Hodgkin's Lymphoma and needs a stem cell transplant. Picture: Alison Wynd Source: News Limited

PAMELA Bou Sejean is fighting for her life.

After 16 months battling an aggressive form of Hodgkin's Lymphoma, the 26-year-old has turned to Facebook in a last ditch bid to find the stem cell donor to keep her alive.

TheVictorian woman in Belmont does not match with any registered bone marrow donor in the world so is now pleading for the public to come forward to be blood tested for a possible match.

"I don't know how much time I have, I get too afraid to ask," Ms Bou Sejean told the Geelong Advertiser.

"I want to focus on what we're doing now.

"The waiting process is hard."

With her life in the balance, Ms Bou Sejean's brother Matt a week ago set up the Facebook page How You Can Help Cure Pamela.

There, Facebook users are told about her fight and how to be blood tested for a possible stem cell match.

Visit link:
Stem cells are my last hope. Can you help?

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New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

By NEVAGiles23

TORONTO, ONTARIO--(Marketwire -03/09/12)- The newest player in the regenerative medicine (RM) field in Canada is taking a collaborative approach to commercializing stem cell and biomaterials products. The Centre for Commercialization of Regenerative Medicine (CCRM) has created an industry consortium that is working together to address real-life bottlenecks in their RM product pipelines.

CCRM's scientific leadership is recognized by the global RM community as being world-leading. According to Michael May, CEO of CCRM, partnering with industry completes the puzzle. "By working with industry, CCRM captures business expertise that informs product development and commercialization. We already had access to some of the best scientific minds in the field and now we have access to seasoned industry experts. This is key to our success and will accelerate product development."

The members of the industry consortium represent the key sectors of the RM industry: therapeutics, devices, reagents, and cells as tools. CCRM has built three core development platforms: reprogramming, cell manufacturing, and biomaterials and tissue mimetics. The intellectual property and infrastructure of CCRM's six research institution partners and support from 20 leading RM companies will enhance Canada's already strong leadership role in the RM field.

"CCRM is uniquely positioned to meet the needs of industry and academia," explains Greg Bonfiglio, Chair of CCRM's Board of Directors. "CCRM boasts scientific expertise and state-of-the-art resources in its development lab and this combination will benefit the regenerative medicine community that can capitalize on our ability to complete projects quickly and cost competitively."

The industry consortium members are as follows:

About the Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

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New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

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Patient dies during procedure

By Sykes24Tracey

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

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Patient dies during procedure

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Doctor accused of illegal stem cell therapy suspended

By NEVAGiles23

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

Read this article:
Doctor accused of illegal stem cell therapy suspended

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Oklahoma bill proposes umbilical cord blood bank

By daniellenierenberg

OKLAHOMA -- An Oklahoma House subcommittee recently approved a bill that would provide state funding for an umbilical cord blood bank. Doctors say the cord blood provides a source of stem cells without causing harm to an unborn child.

Oklahoma State Representative John Enns nearly lost his life after the Tracker he was driving rolled over, breaking his back in 3 places and leaving him paralyzed.

"Before my accident which was in 2004, I was a microbiology professor I taught about these stemcells and I taught the difference between embryonic and adult stem cells, which is huge," Enns said. "My accident happened and then I got even more involved in because this is something that may help a paralyzed person in the future with spinal cord injuries help them to actually get up and walk."

Enns now spends most his time in a wheelchair but continues to research the benefits of umbilical cord blood. He recently authored a bill that would fund a public umbilical cord blood bank for the state.

"What we will do with that is because it is pretty expensive to get it started, we will increase the amount that you pay when you get a birth certificate by $5. This will have a 5 year sunset on it which means in 5 years it will go away," Enns said.

"After the baby is delivered and the placenta is about to be thrown a way the cells can save the life of someone who has luekemia or a genetic problem where replacing their existing bone marrow is important to their cure."

OBI's president, Dr. John Armitage, says the benefits of having an umbilical cord blood bank greatly outweighs its cost..

"There is this future benefit that cant be underestimated," Armitage said. "These cells are going to eventually be used by biotechnology firms to do amazing things in terms of new tissue generation and repairing anything from hearts to any tissue in the body."

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Oklahoma bill proposes umbilical cord blood bank

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Neuralstem Shows Solid Progress in Spinal Cord Neural Stem Cell Trial for ALS

By Dr. Matthew Watson

MissionIR would like to highlight Neuralstem, Inc. (NYSE AMEX: CUR). The company's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. In addition to ALS, Neuralstem is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia, chronic stroke, and Huntington's disease.

In the company's news yesterday,

Neuralstem reported dosing of the fourteenth patient in its ongoing Phase I clinical trialing of the companys spinal cord neural stem cells in ALS (amyotrophic lateral sclerosis or Lou Gehrigs disease), marking the second patient to receive cells in the cervical (upper back) region of the spine and the trials first female patient. This is the first FDA-approved neural stem cell trial for the treatment of ALS.

This treatment is designed to help remediate breathing function loss associated with progressive ALS, and the transplantation of stem cells observed in the trial will be keenly watched for safety/efficacy of spinal cord neural stem cells, as well as the intraspinal transplantation method. The first twelve patients received lumbar (lower back) transplants and the trial has now been underway since January of 2010.

Having begun with non-ambulatory patients and progressing to patients able to walk, this trial has now entered into the final six patients, all of whom will receive cervical transplants, with trial conclusion projected for six months after the final surgery is complete. The proprietary CUR spinal cord delivery platform with floating cannula has helped tremendously in making this dream a possibility and represents a true breakthrough in the field, making the first ever intraspinal injections feasible.

Chairman and CSO of CUR, Karl Johe, PhD., was proud to be breaking new ground with this latest cohort of patients, as it represents a major milestone for the trial, with direct implantation of cells into the gray matter of the spinal cord in the cervical region. Dr. Johe was especially proud of the potential these successful surgeries represent for the numerous patients who suffer from significant quality of life impairment due to ALS. With the 14th successful transplant notched into their belts, CUR is confident that the demonstration of safety in this novel procedure is going quite well.

This is a huge coup for CUR which is also making significant advancements towards developing a robust cell therapy platform capable of addressing a wide range of major central nervous system conditions, ranging from spinal cord injuries and chronic stroke, to ischemic spastic paraplegia and other crippling conditions. The company has an IND submitted to FDA for Phase I safety trials in chronic spinal cord injury.

The company is also well-positioned to service systematic screening needs in the large chemical library space. With proprietary screening technology and the ability to generate appropriate human neural stem cell lines, CUR is ready to leverage discovered/patented compounds that help to stimulate brain activity and neuron regeneration. The potential exists to even reverse debilitating CNS conditions.

The company has also received FDA clearance to conduct a Phase Ib safety trial for their first small molecule compound, NSI-189, for treatment of MDD (major depressive disorder); technology that could easily pan out into schizophrenia, bipolar disorder, and Alzheimers offerings.

About MissionIR

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Neuralstem Shows Solid Progress in Spinal Cord Neural Stem Cell Trial for ALS

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BE THE CHANGE: Stem cells are Pamela's last hope – can you help?

By NEVAGiles23

Pamela Bousejean has Hodgkin's Lymphoma and needs a stem cell transplant. Picture: Alison Wynd Source: News Limited

PAMELA Bou Sejean is fighting for her life.

After 16 months battling an aggressive form of Hodgkin's Lymphoma, the 26-year-old has turned to Facebook in a last ditch bid to find the stem cell donor to keep her alive.

TheVictorian woman in Belmont does not match with any registered bone marrow donor in the world so is now pleading for the public to come forward to be blood tested for a possible match.

"I don't know how much time I have, I get too afraid to ask," Ms Bou Sejean told the Geelong Advertiser.

"I want to focus on what we're doing now.

"The waiting process is hard."

With her life in the balance, Ms Bou Sejean's brother Matt a week ago set up the Facebook page How You Can Help Cure Pamela.

There, Facebook users are told about her fight and how to be blood tested for a possible stem cell match.

Mr Bou Sejean who, like the rest of the family, does not match with his sister said "the cure for Pamela is in the body of hundreds of people out there."

Read this article:
BE THE CHANGE: Stem cells are Pamela's last hope - can you help?

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UofL Professor’s study: Stem cells eliminate need for anti-rejection drugs

By raymumme

by Maggie Ruper

WHAS11.com

Posted on March 7, 2012 at 11:50 PM

Updated yesterday at 12:01 AM

LOUISVILLE, Ky. (WHAS11) -- New research published Wed. in the journal Science Translation Medicine, shows organ transplant recipients may not require anti-rejection medication after surgery.

The study, authored by University of Louisville professor Suzanne Ildstad, M.D., suggests bone marrow stem cells are able to trick the recipients immune system into thinking the donated organ is part of the patients natural self. It therefore eliminates the need for patients to take dozens of daily anti-rejection drugs.

Normally, if I have to transplant a kidney into a patient they have to take immunosuppression drugs for their lifetime and that's about 15 to 25 pills a day, said Ildstad.

Louisville native and father of four, Rob Waddell underwent the procedure in 2009 at Northwestern Memorial Hospital. He suffered from Polycystic Kidney Disease since he was 11 years old. His new kidney and the stem cells were donated to him by his next door neighbor.

It was a match and the rest is history. He's what I call my guardian angel," said Wadell.

The results were considered important because the technique worked for patients who did not have well-matched or related donors.

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UofL Professor’s study: Stem cells eliminate need for anti-rejection drugs

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Presentations at the Society of Toxicology Annual Meeting Demonstrate Superior Predictivity of Cellular Dynamics …

By NEVAGiles23

MADISON, Wis., March 8, 2012 /PRNewswire/ --Cellular Dynamics International, Inc. (CDI), the world's largest commercial producer of human induced pluripotent stem (iPS) cell lines and tissue cells for drug discovery and safety, today announced several customer presentations of studies employing the company's iCell products at the Society of Toxicology (SOT) Annual Meeting on March 11 to 15 in San Francisco. A number of these studies demonstrate the superior predictivity of CDI's human iPS cell-derived products compared to other cell models, such as animal models and immortalized cell lines, which are historically used in pharmaceutical drug discovery and toxicity testing.

Customers will present 11 abstracts employing CDI's human cells in their research during the SOT meeting. Several of these compare the superior ability of CDI's iCell Cardiomyocytes and iCell Hepatocytes to predict toxic responses to currently available cell models. Among them:

Puppala, D et al. (Abstract 420 Poster Board -642; Pfizer, Inc.) compared the ability of iCell Cardiomyocytes to a rat cardiac-derived cell line (H9C2) to predict the toxicity of 10 known in vivo cardiac toxins that were not flagged by the company's current in vitro assay systems. They found that iCell Cardiomyocytes showed increases in several toxicity signals and were more accurate in detecting cardiotoxicity than the rat cell line.

Guo, L et al. (Abstract 1168 Poster Board -433; Hoffman-La Roche) utilized sets of reference and internal compounds to determine the accuracy with which iCell Cardiomyocytes can predict arrhythmic effects. Based on drug-induced changes in beating pattern, iCell Cardiomyocytes correctly identified 17 of 19 reference compounds known to cause abnormal ECG patterns in humans and 17 of 17 internal compounds known to cause arrhythmia in non-rodent animals. These results demonstrate the predictive value of utilizing iCell Cardiomyocytes to identify proarrhythmic compounds.

Hong, S et al. (Abstract 1149 Poster Board -414; Bristol-Myers Squibb) evaluated the effects of three drug compounds using both iCell Cardiomyocytes and fetal rat cardiomyocytes utilizing multi-electrode array (MEA) assays. For all three compounds, iCell Cardiomyocytes were better suited than the fetal rat cardiomyocytes at predicting adverse in vivo effects, including those effects that were not discovered until small-scale clinical trials.

Kameoka, S et al. (Abstract 519 Poster Board -237; Hoffman-La Roche) compared the toxicity of three drug candidates previously tested on dog hepatocytes to iCell Hepatocytes and primary human hepatocytes. In dogs, two of the three compounds caused liver toxicity. The profiles of the two toxic compounds were almost identically recapitulated in vitro for both the primary human hepatocytes and iCell Hepatocytes. This study demonstrated that iCell Hepatocytes may be a valuable human model to predict hepatic toxicity in vitro.

Additional SOT presentations employing CDI's iCell products can be found on the SOT Annual Meeting website or at http://www.cellulardynamics.com/sot2012/posters.html.

"These studies are important contributors to the collective understanding that human in vitro cellular model systems are superior to animal models and immortalized cell lines when studying questions of human biology," said Chris Parker, chief commercial officer of CDI. "We recognize that iPS cell-derived tissues are a relatively new model for drug discovery and toxicity testing and must be validated and shown to be superior. It is gratifying that our pharmaceutical customers are presenting data validating the performance characteristics of our heart and liver cells in such an open scientific forum as the Society of Toxicology Annual Meeting. Third-party validation of iCell product performance coupled with CDI's proven ability to deliver human cells in the quantity, quality and purity required for pharmaceutical, biomedical and basic research positions us well for supplying customers with the human cells they need to improve healthcare."

About Cellular Dynamics International, Inc.Cellular Dynamics International, Inc. (CDI) is a leading developer of next-generation stem cell technologies for drug development, cell therapy, tissue engineering and organ regeneration. CDI harnesses its unique manufacturing technology to produce differentiated tissue cells from any individual's stem cell line in industrial quality, quantity and purity. CDI is accelerating the adoption of pluripotent stem cell technology, adapting its methods to fit into standard clinical practice by the creation of individual stem cell lines from a standard blood draw. CDI was founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research at the University of Wisconsin-Madison. CDI's facilities are located in Madison, Wisconsin. See http://www.cellulardynamics.com.

MEDIA CONTACTS:Joleen Rau Senior Director, Marketing & Communications Cellular Dynamics International, Inc. 608 310-5142 jrau@cellulardynamics.com

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Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

By Dr. Matthew Watson

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the potential use of the companys cell encapsulation technology with modified stem cells to treat late stage cancers.

Stem cell therapy is not new to physicians dealing with blood and bone cancers, with stem cell transplants being an important treatment for growing new bone marrow since the 1970s. Recent studies have indicated the potential for using stem cells across a much broader range of cancers is becoming a reality, mostly a result of advances in cell and molecular biology techniques.

Traditional chemotherapy works by targeting the fast-growing cells common to cancer tumors. Unfortunately, chemotherapeutics dont differentiate between healthy and cancerous cells. Patients suffering from metastatic cancers, where tumors have spread to multiple areas of the body, often have substantial difficulties with the chemotherapy needed to treat their disease.

In one case, researchers at City of Hope and St. Jude Children's Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used genetically modified stem cells to activate chemotherapeutic drugs at the tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed. The stem cells were designed to produce a specific enzyme that converts the nontoxic prodrug into the chemotherapeutic agent. This method also targets the brain tumor treatment to remain localized within the brain, similar to the pancreatic cancer clinical trial carried out by SG Austria, providing for high dosage chemotherapy without affecting surrounding tissues and avoiding the severe side effects normally associated with cancer therapy.

Nuvilex believes that incorporating Cell-in-a-Box encapsulation with this type of genetically modified stem cell, along with the proprietary cancer treatment being acquired, could significantly aid and improve patient outcomes.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, We are hopeful for the day when late stage cancers can be routinely and safely treated using genetically modified cells like those used in the pancreatic cancer trial, increasing the ability of clinicians to avoid inducing side effects that typically accompany aggressive chemotherapy and/or radiation. Our cell encapsulation technology will enable practitioners to target tumors while preserving the health of the surrounding tissues. We continue to look for leading stem cell and oncology researchers to partner with us as we bring this technology to market.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

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Florida suspends doctor accused of illegal stem cell therapy

By Sykes24Tracey

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 1:34 PM EST, Thu March 8, 2012

Dr. Zannos Grekos, seen here in 2009, could have his license suspended.

STORY HIGHLIGHTS

(CNN) -- A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy treatment on an elderly patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Dr. Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and allegedly causing the death of an unnamed elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment earlier this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos's activities in 2009 and, at that time, he said he was using stem cell therapy for a company he called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he claimed would help heal crippling diseases, mostly associated with lung problems.

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Cells may spare kidney transplant rejection drugs

By raymumme

WASHINGTON (AP) -- An experimental technique seems to be freeing some kidney transplant patients from having to take anti-rejection drugs.

Researchers transplanted certain cells from the kidney donor's bone marrow along with the new organ. Five of eight transplant recipients who tried the method so far were off immune-suppressing medication up to 2 years later, the researchers reported Wednesday.

The preliminary results were considered important enough to be published in the journal Science Translational Medicine even though the study still is under way, because the technique worked for patients who didn't have well-matched or related donors.

The idea is that if a sort of twin immune system takes root and lasts, it can allow the patient's body to accept the foreign organ and not attack it, said study co-author Dr. Suzanne Ildstad of the University of Lousville. Scientists call it chimerism.

"The most reliable indicator of really being successful at taking someone off immune-suppressing drugs is durable chimerism," says Ildstad, who teamed with doctors at Chicago's Northwestern Memorial Hospital for the research.

Transplant recipients usually must take multiple immune-suppressing pills for life to prevent rejection of their new organ. Those drugs cause lots of side effects, such as raising the risk of cancer and kidney damage.

Other scientists are attempting to tap bone marrow to induce immune tolerance, with varying success.

Ildstad's approach transfuses a special mix of bone marrow cells including blood-producing stem cells and another type named "facilitating cells" that are thought vital for a successful transplant. She filters out still other cells that can become too aggressive and cause a life-threatening disorder named graft-versus-host disease.

Transplant recipients had radiation and chemotherapy, not destroying their own bone marrow but tamping it down to make space for the donated cells, explained study co-author Dr. Joseph Leventhal, a Northwestern transplant surgeon. Five patients who had the dual immunity a year later were weaned off all drugs. Two others whose hybrid immunity faded are faring well using a low dose of one anti-rejection drug. One patient needed a repeat transplant after an infection and didn't get to try weaning.

Much more study is needed to find the best approach but "the results are striking," Dr. Tatsuo Kawai of Massachusetts General Hospital wrote in an accompanying editorial. He is part of a team that in 2008 reported the only other success with a small number of mismatched transplants.

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Stem cell research allows for mismatched kidney transplants

By JoanneRUSSELL25

Donating a kidney may save a person's life - but only if the conditions are precise.

Kidney donors must be related and immunologically matched to their donors and even then, the recipient must take a lifetime of anti-rejection medications, which dont guarantee the organ won't be rejected.

But a new clinical trial from Northwestern Memorial Hospital in Chicago, Ill. has shown how stem cells can be used to trick a recipients immune system into believing the new organ has been part of that persons body all along.

The breakthrough has the potential to eliminate both the risks associated with kidney transplantation and the need for anti-rejection medications within one year after surgery.

Its the holy grail of transplantation, said lead author Dr. Joseph Leventhal, transplant surgeon at Northwestern Memorial Hospital and associate professor of surgery and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine in Chicago, Ill. This notion of being able to achieve tolerance through donor derived cells has been around for more than 50 years, but its translation to the clinic has been quite elusive. This article details the first successful attempt of this in mismatched and unrelated kidney recipients.

The research was published Wednesday in the journal Science Translational Medicine, and it is the first study of its kind in which the donor and recipient were not related and did not have to be immunologically matched. Only 25 percent of siblings are immunologically identical, severely limiting the possibility of being a kidney donor.

The procedure worked by extracting a little bit more from the kidney donor than just their kidney. They also donated part of their immune system. About one month before surgery, bone marrow stem cells were collected from the donor and then enriched with facilitating cells becoming stem cells that will ultimately fool the donors immune system allowing the transplant to succeed.

One day after the kidney transplant occurs, the facilitating cell-enriched stem cells are also transplanted in the recipient, which then prompts the formation of stem cells in the bone marrow. This then causes specialized immune cells similar to the donors immune cells to develop, creating a dual bone marrow system environment, so both the donors immune system and the recipients immune system function inside the persons body.

Leventhal said that the ultimate goal is for the recipient to initially take anti-rejection medications but then slowly wean off of them within a year. According to Leventhal, the drugs come with their own share of negative side effects.

The foundation of clinical transplantation revolves around the use of medicines and suppressive drugs to control the immune system, Leventhal said. These drugs have been very successful in reducing the rates of loss of organs due to acute rejection where side effects include increase risk of infection and cancer, and metabolic side effects, such as the increase risk of hypertension and bone disease. But the drugs themselves are potentially harmful to the organs we transplant. Despite our ability to reduce rates of acute rejection, most individuals go on to lose organs because of chronic (long-term) rejection.

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