Multiple Sclerosis News Blog: Pleasure from Smoking -- and Addiction to It -- Is a Genetic Thing

Pluristem's PLX-MS Shows Potential Benefit in the Prevention of Multiple Sclerosis | Reuters

Mon Aug 11, 2008 7:00am EDT

NEW YORK--(Business Wire)--
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT) a
bio-therapeutics company dedicated to the commercialization of
non-personalized (allogeneic) cell therapy products for a variety of
degenerative, ischemic and autoimmune indications, today announced
that the Company's PLacental eXpanded (PLX-MS) cells have demonstrated
in vivo efficacy in the prevention of Multiple Sclerosis (MS). PLX
cells are Pluristem's placental-derived mesenchymal stromal cells
(MSCs) that have been expanded in the Company's proprietary PluriX(TM)
3-D bioreactor.

In a further analysis aiming to demonstrate the in vivo efficacy
of PLX-MS cells for the prevention of MS, Experimental Autoimmune
Encephalitis (EAE) was induced in mice via immunization with the
MOG35-55 protein on day 0. EAE is an autoimmune inflammatory disease
of the CNS that represents the paradigmatic model for MS. The animals
then received, on day 8, intravenously either PLX-MS or PlasmaLyte,
which served as a control. PLX-MS administration prevented the
appearance of clinical symptoms and signs associated with MS
throughout the 35-day study period compared to those animals receiving
the control. Additionally, the beneficial effects were similar to when
Zappia et. al. used MSCs that were non-placental in origin in this EAE
animal model(1).

Mr. Zami Aberman, Pluristem's President and CEO, commented: "This
trial's remarkable results demonstrated our PLX-MS cells' ability to
prevent the appearance of multiple sclerosis symptoms and showed the
potential for our PLX cells to treat global autoimmune diseases. As a
cellular therapy, our PLX cells, which are derived from human
placenta, a non-controversial, non-embryonic, adult stem cell source,
and stored ready-to-use, could prove to be a readily available
preventive therapeutic alternative for these disorders."

Pluristem is initiating repeated sets of EAE experiments at the
Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at Charite -
University Medicine Berlin, one of the largest independent clinical
research centers in Europe.

(1) Zappia et. al. Mesenchymal stem cells ameliorate experimental
autoimmune encephalitis inducing T cell anergy. Blood. 2005;106:
1755-1761

About Multiple Sclerosis (MS)
Multiple sclerosis (MS), also known as disseminated sclerosis or
encephalomyelitis disseminate, is an autoimmune condition in which the
immune system attacks the central nervous system (CNS), leading to
demyelination. Myelin is the insulating sheath that surrounds nerve
cells (neurons). MS may cause numerous physical and mental symptoms,
and often progresses to physical and cognitive disability. The World
Health Organization (WHO) estimates that over 2.5 million people
globally suffer from MS, which represents a current market of
approximately $5.4 billion for disease-modifying agents to treat the
disorder.

About Pluristem
Pluristem Therapeutics Inc. is a bio-therapeutics company
dedicated to the commercialization of non-personalized (allogeneic)
cell therapy products for the treatment of several severe
degenerative, ischemic and autoimmune disorders. The Company is
developing a pipeline of products, stored ready-to-use, that are
derived from human placenta, a non-controversial, non-embryonic, adult
stem cell source.

These placental mesenchymal stromal cells (MSCs) are expanded in
the Company's proprietary PluriX(TM) 3D bioreactor, which imitates the
natural microstructure of bone marrow and does not require
supplemental growth factors or other exogenous materials. Pluristem
believes that the resultant PLX (PLacental eXpanded) cells are
multi-potent and able to differentiate into a variety of cell types.
Recent evidence also suggests their efficacy may be related to the
secretion of cytokines or other potent immune modulators. Furthermore,
PLX cells are immune privileged and have immunomodulatory properties,
thus protecting the recipient from immunological reactions that often
accompany transplantations.

Pluristem's first product in development, PLX-PAD, is intended to
improve the quality of life of millions of people suffering from
peripheral artery disease (PAD). The Company's products in development
also include PLX-BMT, targeting the global shortfall of matched tissue
for bone marrow transplantation (BMT) by improving the engraftment of
hematopoietic stem cells (HSCs) contained in umbilical cord blood;
PLX-STROKE, targeting ischemic stroke; PLX-MS, targeting Multiple
Sclerosis; and PLX-IBD, targeting Inflammatory Bowel Disease (IBD),
which includes Crohn's disease and Ulcerative Colitis.

Pluristem has offices in the USA with research and manufacturing
facilities in Israel.
See our product animation on YouTube:
here

  
here

Safe Harbor Statement

This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995 and federal securities laws. For
example, when we say that the trial's remarkable results demonstrated
our PLX-MS cells' ability to prevent the appearance of multiple
sclerosis symptoms and showed the potential for our PLX cells to treat
global autoimmune disease, or that as a cellular therapy, our PLX
cells could prove to be a readily available preventive therapeutic
alternative for these disorders, we are using forward-looking
statements.

These forward-looking statements are based on the current
expectations of the management of Pluristem only, and are subject to a
number of factors and uncertainties that could cause actual results to
differ materially from those described in the forward-looking
statements.

The following factors, among others, could cause actual
results to differ materially from those described in the
forward-looking statements: changes in technology and market
requirements; our technology may not be validated as we progress
further and our methods may not be accepted by the scientific
community; we may be unable to retain or attract key employees whose
knowledge is essential to the development of our products; unforeseen
scientific difficulties may develop with our process; results in the
laboratory may not translate to equally good results in real surgical
settings; our patents may not be sufficient; our products may harm
recipients; changes in legislation; inability to timely develop and
introduce new technologies, products and applications; loss of market
share and pressure on pricing resulting from competition, which could
cause the actual results or performance of Pluristem to differ
materially from those contemplated in such forward-looking statements.

Except as otherwise required by law, Pluristem undertakes no
obligation to publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date hereof or
to reflect the occurrence of unanticipated events. For a more detailed
description of the risk and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time with
the Securities and Exchange Commission.

For more information visit our website at www.pluristem.com, the
content of which is not part of this press release.
Pluristem Therapeutics Inc.
William Prather RPh, MD, 303-883-4954
Sr. VP Corporate Development

bill@pluristem.com
Copyright Business Wire 2008
© Thomson Reuters 2008 All rights reserved
http://www.reuters.com/article/pressRelease/idUS108866+11-Aug-2008+BW20080811

Tysabri

What Are Your Biogen Idec Options?
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The Food & Drug Administration decided to allow Tysabri to return to market in 2006 with a warning to potential consumers. Biogen and its partner Elan (ELN) ...
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Elan Jumps into Recovery Mode
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Elan Corporation (NYSE: ) shares opened higher on Monday after falling sharply last week after more safety concerns hit its Tysabri drug. ...
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Biogen-Idec, Elan: Panic Selling Creates Interesting Opportunity
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I had based that recommendation on the potential success of Tysabri. In August, both biotech companies announced no plans to take Tysabri off the market and ...
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Are viruses alive?

Is the ability to sicken another organism a criterion for being "alive"?

By The Scientist Community

Ann Bartlett, who blogs on HealthCentral.com about her Type 1 diabetes, was frustrated when doctors tied all her symptoms to diabetes.

Ann Bartlett, who blogs on HealthCentral.com about her Type 1 diabetes, was frustrated when doctors tied all her symptoms to diabetes. (By Dominic Bracco Ii -- The Washington Post)

Seeking a Cure, Patients Find Dose of Conversation Online
Intimate exchanges among people living with disease are part of an unconventional strategy HealthCentral, a start-up trying to transform the business of online health, is following in its attempt to become an online destination for health information. APF and HealthCentral are in partnership to provide CareCentral for caregivers and a blog written by Will Rowe, APF's Chief Executive Officer.

Multiple Sclerosis

Many drugs being investigated for chronic progressive multiple sclerosis are immunosuppressants, which block certain factors in the immune system that ...

http://adam.about.com/reports/000017_8.htm

Immunosuppressants for Chronic Progressive MS

Many drugs being investigated for chronic progressive multiple sclerosis are immunosuppressants, which block certain factors in the immune system that contribute to the inflammatory process. Each of these drugs can produce serious side effects, including susceptibility to infection and many others. Evidence on benefits of most is uncertain, mainly because of high toxicity in many of them or study limitations. Still, some may help some patients with severe MS. Among immunosuppressant agents or procedures that have been investigated with little or no obvious benefits or unacceptably high side effects are total lymphoid irradiation, sulfasalazine, cyclosporine, acyclovir, and oral bovine myelin.

Mitoxantrone. Mitoxantrone (Novantron) is the first agent to be approved specifically for secondary progressive MS. Two studies suggested that it may be of some help in reducing progression and relapse rates. Cumulative doses can have toxic effects on the heart, however, and so the drug is only used for a limited period.

Methotrexate. In some patients, low doses of the immunosuppressant methotrexate may slow the course of chronic-progressive MS, particularly in those with secondary progressive MS. To date, studies have found beneficial effects only on the upper body, however. Although this drug, like all immunosuppressants, can have toxic side effects, it may be taken in low doses for MS and so side effects are generally minimal.

Cyclophosphamide. Cyclophosphamide (Cytoxan) blocks cell growth and also suppresses the immune system. Some studies, but not all, have reported benefits for patients with chronic progressive MS. Two small 2001 studies suggested that monthly intravenous administration or a combination with interferon-beta may help some patients with rapidly deteriorating MS. Cyclophosphamide has many side effects, including hair loss, nausea, vomiting, infertility, lung scarring, and blood abnormalities, and should be used for patients who do not respond to methotrexate.

Azathioprine. Azathioprine (Imuran) is designed to suppress the immune system and reduce the number of cells attacking the CNS myelin. It is used with or without steroids and is sometimes used as an alternative to patients with relapsing-remitting MS who do not respond to either interferon beta or glatiramer acetate. One study reported that 40% of patients had not experienced a relapse after taking the drug for three years, although others report only modest benefits. The drug has no effect on progression of disability.

Cladribine. Cladribine (Leustatin) may be effective in delaying progression in patients with chronic progressive MS. It has no significant effect on relapsing-remitting MS.
Article Page Navigation
http://adam.about.com/reports/000017_8.htm

Modigene Awarded Israeli Government Grant to Support Development of Its Longer-Acting Interferon Beta

From PR Newswire - Aug 05, 2008

NES-ZIONA, Israel, August 05, 2008 /PRNewswire-FirstCall/ -- Modigene Inc. today reported that its Israeli-based R&D subsidiary has received approval for a special grant from the Israeli Office of the Chief Scientist in support of the company's development program for interferon-beta-CTP (IFN-Beta-CTP), its longer-acting version of interferon beta. Interferon-beta is an injectable treatment for multiple sclerosis (MS).
Read Full Article Article Summary

Lower Sales of Tysabri Predicted
From The Boston Globe - Aug 06, 2008
Financial analysts are predicting the number of patients using Tysabri will fall far below Biogen Idec Inc.'s forecast, following the Cambridge biotech company's disclosure last week that two more patients using the multiple sclerosis drug contracted a potentially fatal brain disease.
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Impax Reports Positive Results in Phase III Trial with IPX056
From Business Wire NewsExpress - Aug 07, 2008
HAYWARD, Calif.--(BUSINESS WIRE)--Aug 7, 2008 - Impax Laboratories, Inc. today announced that IPX056, an investigational extended-release formulation of baclofen, has met its clinical endpoints in a Phase III study of spasticity in multiple sclerosis patients.
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Good Results Seen with Intrabone Cord Blood Transplant for Leukemia
GENOA, Italy -- Leukemia patients who had umbilical cord blood cells from unrelated donors injected into their bone showed excellent levels of engraftment and low rates of graft-versus-host disease, researchers here said. full story

http://www.medpagetoday.com/HematologyOncology/Leukemia/tb/10495

ProteoTech's Exebryl-1 Enters Human Trials for Alzheimer's Disease
From PR Newswire Europe (inc. UK Disclose) - Aug 07, 2008
KIRKLAND, Washington, Aug. 7, 2008 /PRNewswire/ -- ProteoTech Inc. today announced that it has completed regulatory IND requirements and has been cleared by the FDA to initiate its Phase 1 human clinical trial on Exebryl-1, a novel small molecule drug targeting toxic beta-amyloid protein accumulation for the treatment of Alzheimer's disease. ProteoTech initiated its Phase 1 human trial on July 29, 2008.
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New Recommendations from the FDA Concerning the Monitoring of Cardiac Function in People Taking Mitoxantrone

Aug 11, 2008

http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=264

Is Pain All In the Mind?
New research shows why some people are better at coping with pain than others. Pioneering studies are providing insights into why some people experience debilitating chronic pain long after an injury has healed, as well as why some are more prone to pain than others.

Diabetes 'killing one in ten adults'
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More than one in ten adult deaths in England are caused by diabetes, new figures show. And in excess of half a million people are unaware they have the ...
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Diabetes cooking school planned
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Union Hospital and Purdue University Cooperative Extension Service are teaming up to offer Dining with Diabetes Cooking School. This program will be offered ...
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APF Board Members Speak About Pain on Health Radio Show
APF Board Members Maggie Buckley and Michael H. Moskowitz, M.D., M.P.H. talk about pain from a patient and provider perspective on Body Language. Body Language is a one-hour program bringing information and empowering consumers to expand the conversation about health and wellness. Click here to listen to the 14 minute audio segment with Maggie and Michael. Click on Body Language to hear the whole one hour show on pain.

Lack of Energy May Signal Health Problems in Older Patients
NEW YORK -- Although anergia is common in older patients, it may not be just a normal part of aging, but a sign of more serious health problems, researchers here said. full story

http://www.medpagetoday.com/Geriatrics/GeneralGeriatrics/tb/10481

Pleasure from Smoking -- and Addiction to It -- Is a Genetic Thing
ANN ARBOR, Mich. -- The nicotine "buzz" that leads to addiction in some people arises from a genetic mutation that enhances pleasurable responses, investigators here reported. full story

http://www.medpagetoday.com/PrimaryCare/Smoking/tb/10483

Gene Variant May Decide Who Smokes and for How Long

Teens See Abstinence as a Step to Sexual Activity
SEATTLE -- Teens don’t see "abstinence" and "having sex" as polar opposites, researchers here said. full story

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Pain & Policy Studies Group Updates Key Documents
The Pain & Policy Studies Group at the University of Wisconsin has just released their 2008 update of Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (5th Edition). This document examines U.S. federal and state policies relating to the use of controlled substances for the medical management of pain, and helps to provide a framework for deciding which policies should be removed, as well as recommended language to guide the development of new and more balanced policies. Also available is

Achieving Balance in State Pain Policy: A Progress Report Card, which quantifies state pain policies, and tracks their progress to promoting pain management and reducing policy barriers by comparing 2008 state policy grades with those from 2000, 2003, 2006, and 2007.
Common Fertility Treatments Little Use

McMaster Stem Cell and Cancer Research Institute

Stem cell news deluge
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Jon Draper, a scientist in the McMaster Stem Cell and Cancer Research Institute, focused on producing early endoderm cells from human embryonic stem cells. ... The researchers focused on generating stable progenitor cells capable of ...
Science and Reason - http://scienceandreason.blogspot.com/

A disease cell line library

Researchers have created 20 disease-specific pluripotent cell lines from skin and bone marrow cells of patients with genetic disorders

By Andrea Gawrylewski

Silencing HIV

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AVI BioPharma Announces Approval to Conduct Systemic Trial for ...
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Suven Presents Positive Preclinical Data for SUVN-502 at Alzheimer's Conference
From PharmaLive News Archive - Aug 04, 2008
HYDERABAD, India, Aug. 4, 2008 – Suven presented preclinical data for SUVN-502, its lead 5-HT6 antagonist drug candidate, at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease (ICAD-2008) in Chicago and Drug Discovery & Development of Innovative Therapeutics (DDT-2008) in Boston.
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Today's Top News

1. MA gov. signs pharma gift reporting law

By Anne Zieger
Comment | Forward

Massachusetts governor Deval Patrick (D) has signed legislation that, in addition to promoting electronic medical records and boosting primary care training, imposes one of the country's toughest limits on gifts to clinicians. The new measure, which not too surprisingly drew strong opposition from the pharmaceutical companies, bans certain types of gifts (such as sports tickets and free travel) while requiring pharmaceutical companies and medical devicemakers to publicly disclose any gifts worth over $50. As controversial as the gift restrictions and reporting were, they actually weren't tough enough for some critics, who had hoped to see drugmaker and devicemaker gifts banned entirely.

In addition to banning some gifts to clinicians, the new law directs the University of Massachusetts Medical School to grow its class size to allow for training of primary care doctors, as well as helping some PCPs repay med school loans. What's more, it allocates $25 million to help award grants to doctors and hospitals who want to boost their use of health IT, particularly electronic medical records. On top of all of this, the law gives the state greater power over health plan rates than regulators have had in more than a decade, observers say.

Despite the importance of these changes, the drug gift ban has gotten by far the most attention, according to Massachusetts pols. This is almost certainly because drugmakers, with their deep pockets, have stirred the pot vigorously on this issue, hoping not to see such a law enacted in other states.
To learn more about the new law:
- read this article from The Boston Globe

2. NJ law caps hospital prices for uninsured

By Anne Zieger
Comment | Forward

Following a trend emerging in recent years across the country, New Jersey has enacted a law capping hospital prices for low- and middle-income uninsured patients. The new law is one of four bills signed by the state's governor, including a measure expanding the state's power of oversight over troubled hospitals. Under the new pricing law, hospitals aren't allowed to charge more than 15 percent above

Medicare's rate for services to uninsured patients with incomes below 500 percent of the federal poverty level. (The poverty level is presently $21,200 for a family of four.) The monitoring law, meanwhile, allows the state's health commissioner to appoint an official for hospitals at risk of foreclosure, as measured by the guidelines for intervention created by the New Jersey Commission on Rationalizing Health Care Resources.

To find out more about these measures:
- read this Modern Healthcare article (reg. req.)
Related Articles:
NJ hospitals going under as state bailout cash ends
St. Louis hospitals give uninsured discounts
MN health systems pay back uninsured patients

3. CA providers, officials fight over balance billing

By Anne Zieger
Comment | Forward

The battle is on in California over the issue of when it's legal to balance-bill patients, with providers contending that they need to issue such bills when health plans underpay. The dispute comes because in that state, the law is apparently unclear on a key issue--whether providers who don't contract with a health plan can balance-bill patients who see them as out-of-network providers.

At present, the California Department of Managed Health Care is suing Prime Healthcare Services in an effort to stop the hospital network from billing patients for out-of-network emergency care fees. The DMHC contends that Prime illegally billed up to 6,000 Kaiser Permanente members for outstanding balances, as well as members of other health plans. (It doesn't help matters any, politically, that Prime has made a routine practice of dropping managed care contracts when it acquires a hospital, seemingly in an effort to get higher out-of-network reimbursement rates.) The DMHC argues that state law bans balance billing for emergency care because doctors and hospitals have an implied contract to treat patients in emergencies--as required by EMTALA--which gives insurers the obligation to pay for services.

Providers don't care for the DMHC's reasoning, according to AMA newspaper American Medical News. They say that under this interpretation of the law, health plans can unilaterally decide what they're going to pay, and are likely to pay unfair rates for emergency services. They note that balance billing for emergency services was found legal under a 2006 state appeals court ruling, which held that "contracting providers" who can't balance bill are only those with an actual contract.

Meanwhile, the DMHC continues to press forward with regs banning all balance billing, as mandated by Gov. Arnold Schwarzenegger (R) in 2006.

To learn more about this dispute:
- read this AMNews piece
Related Articles:
CA sues Prime Healthcare for balance-billing insured patients
CA law would ban balance billing for ED services
Schwarzenegger orders end to balance billing

4. LifePoint profits more than double

By Anne Zieger
Comment | Forward

Hospital operator LifePoint Hospitals has reported its second quarter profits, and they're looking good, particularly when compared with the company's rough first quarter. The company, which is based in Brentwood, TN, said profits more than doubled for the most recent quarter. It booked net income of $30.5 million for the quarter, compared with $13.4 million in the same quarter last year. Revenue was up 4.1 percent, to $680.8 million. The company, a 1999 spin-off of HCA, runs 48 acute-care hospitals in 17 states. It runs hospitals in non-urban communities and seeks to be the only hospital in many of these communities.

These profit increases came despite a 2.3 percent drop in inpatient admissions fueled by its ending two unprofitable obstetric programs, as well as the declining economy. On the other hand, though, the company saw higher-acuity patients, and also had less bad debt. More importantly, the company says, executives did an intensive review of its seven largest hospitals, which has helped it rethink its service lines and drop unprofitable services. Meanwhile, the company's been working on building its medical staff, which should increase 5 percent company wide this year, the company said.

To learn more about LifePoint:
- read this Modern Healthcare article (reg. req.)

5. Data on TX HIV/AIDS patients stolen

By Anne Zieger
Comment | Forward

Recently, a low-level administrator in Texas' Harris County Hospital District inappropriately downloaded medical and financial records for 1,200 patients with HIV, AIDS and other medical conditions onto a flash drive. The drive was then stolen. Now, as investigators look into the incident, it seems likely that the administrator violated HIPAA law when she downloaded the data, which includes total files on the patients. Under HIPAA, the District could face a $100 fine per violation (though a $25,000 per year cap applies).

In response to the theft, the District has announced that it will allow patients affected by the breach to enroll in credit protection programs at its expense. Meanwhile, it has tightened up policies and procedures regarding the use of transportable media devices like flash drives, a spokesperson said.

The question now is whether the District will face HIPAA repercussions. Generally speaking, the federal government has done little to impose HIPAA fines. However, HHS recently fined Seattle's Providence Health & Services $100,000 for allowing unencrypted electronic protected health information to be lost or stolen in 2005 and 2006. The backup tapes, optical disks and laptops in question contained data on more than 386,000 patients.

To learn more about this incident:
- read this Houston Chronicle article

Multiple Sclerosis News Blog

Monday, August 11, 2008

Pleasure from Smoking -- and Addiction to It -- Is a Genetic Thing

Pluristem's PLX-MS Shows Potential Benefit in the Prevention of Multiple Sclerosis | Reuters

Immunosuppressants for Chronic Progressive MS

New Recommendations from the FDA Concerning the Monitoring of Cardiac Function in People Taking Mitoxantrone

McMaster Stem Cell and Cancer Research Institute

Today's Top News

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