Celldex Therapeutics Receives Fast-Track Designation For CDX-110, A Novel EGFRvIII Vaccine For Glioblastoma

Celldex Therapeutics
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation to Celldex’s CDX-110 for the treatment of
EGFRvIII expressing Glioblastoma Multiforme (GBM). GBM is the most common
and aggressive form of primary brain cancer and carries a very poor
prognosis with current therapy. CDX-110 is an immunotherapy that targets
the tumor-specific growth promoter EGFRvIII that can be expressed by GBM.

In the ACTIVATE Phase 2a study, GBM patients treated with CDX-110
showed a median survival time of 30 months, more than a 100 percent
increase in survival, versus the historical control’s median of 14.5
months. The study has demonstrated a median time-to-progression of 13
months (p=0.0001) versus the historical control’s median of 6.4 months. GBM
that recurred after treatment with CDX-110 consistently lost EGFRvIII
expression with its aggressive growth signal. An extension study, ACT II,
which combines CDX-110 with chemotherapy in a similar patient population,
has not yet reached median time-to-progression or survival. Preliminary
progression free survival (PFS) and overall survival (OS) data in ACT II
look very similar to the ACTIVATE experience, and the data suggest that
chemotherapy and CDX-110 can be administered concurrently while still
maintaining strong immune responses.

In September, Celldex randomized its first patient into ACT III, a
definitive Phase 2/3 randomized study of CDX-110 with radiation and
temozolomide in patients with newly-diagnosed GBM. The clinical trial is
investigating the anticancer activity, impact on survival, and safety of
the addition of CDX-110 vaccine to standard of care, versus standard of
care alone. Celldex recently announced that CDX-110 has also been granted
Orphan Drug Status by the FDA. Celldex Therapeutics announced a definitive
merger agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) in
October 2007.

“Fast Track status acknowledges CDX-110′s potential to fill an unmet
need for glioblastoma patients and gives it priority within the FDA,” said
Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics.
“Confirmation of the promising results we’ve already observed is a high
priority at Celldex, as it is within the brain cancer community in

About CDX-110

CDX-110 is an investigational immunotherapy that targets the tumor
specific molecule EGFRvIII, a functional variant of the epidermal growth
factor receptor (EGFR), which is a protein that has been well validated as
a target for cancer therapy. This particular variant, EGFRvIII occurs in
about 40 percent of Glioblastoma Multiforme (GBM) patients. It was
discovered in a collaborative effort between Dr. Bert Vogelstein and Dr
Albert Wong at Johns Hopkins University and Dr. Darell Bigner at Duke
University. Unlike EGFR, EGFRvIII is not present in normal tissues,
suggesting this target will enable the development of a tumor-specific
therapy for cancer patients. Furthermore, EGFRvIII is a transforming
oncogene that can directly contribute to cancer cell growth. While
originally discovered in GBM, the most common and aggressive form of brain
cancer, the expression of EGFRvIII has also been observed in various other
cancers such as breast, ovarian, metastatic prostate, colorectal, and head
& neck cancers. Celldex has exclusive rights to EGFRvIII vaccines and is
pursuing the development of CDX-110 for GBM therapy, as well as in other
cancers through additional clinical studies.

About Fast Track Drug Designation

Under the FDA Modernization Act of 1997, designation as a Fast Track
product for a new drug or biological products means that FDA will take such
actions as are appropriate to expedite the development and review of the
application for approval of such product. FDA may also evaluate for filing
and commence review of portions of an application for approval of a Fast
Track product under certain conditions.

About Celldex Therapeutics, Inc.

Celldex Therapeutics, Inc. is a biotechnology company focused on
developing therapeutic vaccines that target and stimulate the body’s immune
system for the treatment of cancer, infectious and autoimmune diseases.
Celldex has three product candidates already in or about to enter clinical
development targeting multiple cancers and Hepatitis B. Four additional
product candidates are in preclinical development for cancer and autoimmune
disease. Celldex’s proprietary technology platform uses fully human
monoclonal antibodies administered directly to patients to target and
stimulate dendritic cells – key cells within the immune system. The Company
is headquartered in Phillipsburg, New Jersey. On October 22, 2007, Celldex
and AVANT Immunotherapeutics, Inc. announced that they had signed a
definitive merger agreement. The all-stock transaction, approved by both
companies’ Boards of Directors, will combine Celldex and AVANT. Closing of
the merger is contingent upon a vote of approval by the current
stockholders of AVANT at a special meeting expected to take place in the
first quarter 2008. For more information, please visit the website:

Additional Information about the Merger and Where to Find It This
communication contains “forward-looking” statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements are
typically preceded by words such as “believes,” “expects,” “anticipates,”
“intends,” “will,” “may,” “should,” or similar expressions. These forward-
looking statements are subject to risks and uncertainties that may cause
actual future experience and results to differ materially from those
discussed in these forward-looking statements. Important factors that might
cause such a difference include, but are not limited to, costs related to
the Merger, failure of AVANT’s stockholders to approve the Merger; AVANT’s
or Celldex’s inability to satisfy the conditions of the Merger; AVANT’s
inability to maintain its NASDAQ listing; the risk that AVANT’s and
Celldex’s businesses will not be integrated successfully; the combined
company’s inability to further identify, develop and achieve commercial
success for new products and technologies; the possibility of delays in the
research and development necessary to select drug development candidates
and delays in clinical trials; the risk that clinical trials may not result
in marketable products; the risk that the combined company may be unable to
successfully secure regulatory approval of and market its drug candidates;
the risks associated with reliance on outside financing to meet capital
requirements; risks associated with Celldex’s new and uncertain technology;
risks of the development of competing technologies; risks related to the
combined company’s ability to protect its proprietary technologies; risks
related to patent-infringement claims; risks of new, changing and
competitive technologies and regulations in the U.S. and internationally;
and other events and factors disclosed previously and from time to time in
AVANT’s filings with the Securities and Exchange Commission, including
AVANT’s Annual Report on Form 10-K for the year ended December 31, 2006.
The companies do not undertake any obligation to release publicly any
revisions to such forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.

This communication may be deemed to be solicitation material in respect
of the proposed merger of AVANT and Celldex. In connection with the
proposed merger, AVANT and Celldex intend to file relevant materials with
the SEC, including AVANT’s joint registration statement/proxy statement on
security holders will be able to obtain the documents free of charge at the
SEC’s web site, sec, and AVANT shareholders will receive
information at an appropriate time on how to obtain transaction-related
documents for free from AVANT. Such documents are not currently available.

Participants in the Solicitation

The directors and executive officers of AVANT and Celldex may be deemed
to be participants in the solicitation of proxies from the holders of AVANT
common stock in respect of the proposed transaction. Information about the
directors and executive officers of AVANT is set forth in the proxy
statement for AVANT’s most recent 10-K, which was filed with the SEC on
March 16, 2007. Investors may obtain additional information regarding the
interest of AVANT and its directors and executive officers, and Celldex and
its directors and executive officers in the proposed transaction by reading
the proxy statement regarding the acquisition when it becomes available.

Celldex Therapeutics, Inc.

A Prospective fMRI Study Of Dopamine-Related Activity Of Food Reward Circuits In The Brain And Weight Gain

Research to be presented at the Annual Meeting of the Society for the Study of Ingestive Behavior (SSIB), July 28 – August 1, 2009, the foremost society for research into all aspects of eating and drinking behavior, finds that women who possess genetic modifications associated with low activity of the reward neurotransmitter dopamine in the brain when they imagine eating appetizing foods are more prone to weight gain. Functional Magnetic Resonance Imaging (fMRI) scans of brain activity revealed that women who had lower activity in food reward regions of the brain and who had genetic modifications associated with lower dopamine activity showed the greatest weight gain after one year. Eric Stice from the Oregon Research Institute says, “These findings provide some of the first prospective evidence that people who experience blunted reward from food may compensate by overeating, increasing risk for unhealthy weight gain.” Overconsumption of appetizing foods may occur in an attempt to increase brain reward in less responsive systems. The results of this study highlight the need for further research into the role that neural reward systems play in the development of obesity. “It may be useful for individuals who show low food-related reward to increase their physical activity, which not only promotes activity the same reward circuitry but also reduces unhealthy weight gain from overeating” says Stice.

Lead author: Eric Stice, Oregon Research Institute, Eugene, OR, USA

Co-authors: S. Spoor and C. Bohon, Oregon Research Institute and University of Oregon, C.N. Marti, University of Texas at Austin, USA.

Jamie Price

Society for the Study of Ingestive Behavior

AdvaCAL Calcium Effective Against Bone Loss In Postmenopausal Women

With Osteoporosis an increasing concern among women of all ages, a recent report in the medical journal Osteoporosis International found that women taking the AAACa (AdvaCAL®) calcium supplements had the highest bone density increase among 32 different calcium studies conducted between 1977 and 2008. The 32 studies involved 3,169 postmenopausal women, 79 skeletal measures and 7 different types of calcium, including dairy.

The report entitled “The Effect of Calcium Supplementation on Bone Loss in 32 Controlled Trials in Postmenopausal Women” was authored by calcium researcher Christopher Nordin, M.D. of Australia. Nordin concluded that calcium intake prevented bone loss in postmenopausal women for at least four years. Results from the 32 studies showed a wide range of bone density changes from taking different types of calcium. Most changes were negative, meaning many women taking calcium still lost bone mass each year. However, AdvaCAL calcium users averaged a 1.5% bone density increase per year, the highest increase among all 79 skeletal measures. Research details are available at stoposteo.

These results dovetail with other published calcium research. A 2007 article in the journal The Lancet showed that AdvaCAL produced the most favorable change to fracture-risk among 17 different calcium studies between 1992 and 2006. The 17 fracture studies involved men and women aged 50+, taking 6 different calciums either alone or with vitamin D.


AdvaCAL is natural ionic calcium from Japan. Oyster shells are smelted at high temperatures, creating a bioavailable calcium ash. Smelting also removes lead and other impurities. Finally, the calcium is blended with HAI, an amino acid complex from seaweed. HAI has been scientifically shown to boost calcium absorption. Both the calcium and HAI in AdvaCAL have been awarded patents.

“We are pleased but not surprised by AdvaCAL’s top ranking in both reports” comments Andrew Lane, president of LaneLabs, the US supplier of AdvaCAL. “The FDA recommends adequate calcium intake with vitamin D, along with physical activity to reduce the risk of osteoporosis in later life. These two reports highlight some differences among calcium supplements. AdvaCAL is a unique Osteoporosis fighter.”


Brittle Table Salt Can Stretch Like Taffy In The Nanoworld – Nano Letters

Researchers in New Mexico are reporting the surprise discovery that common table salt – so brittle that it crushes easily between a thumb and forefinger – becomes a super plastic in the weird environs of the nanoworld. The super-elastic salt can stretch like taffy to twice its original length without breaking. The discovery could lead to new insights into the role of salt in a wide variety of situations ranging from helping clouds to form to triggering asthmatic attacks in people, they say. Their study is in the current issue of ACS’ Nano Letters, a monthly journal.

Nathan Moore and colleagues note in the new study that researchers have known for years that metals like gold, lead and aluminum can be pulled into nanowires 1/50,000th the width of a human hair. Like other materials of such tiny dimensions, their properties change. Materials that conduct electricity poorly, for instance, become good conductors and materials that break easily develop new strength. That’s why nanomaterials may form the basis of futuristic technologies that spawn new industries. But until now, no one expected to create nanowires from crystals of common table salt, or sodium chloride, which crumbles so easily.

The scientists made the unusual discovery while studying how water coats salt crystals using a microscope specially designed to observe mechanical and adhesive forces. They detected an unusual attractive force between the diamond tip of the microscope and the salt surface. After a series of tests, the researchers showed that the force encountered may have been caused by the presence of salt nanowires. In a similar test, they were able to capture images of salt nanowires being formed and stretched. The finding is “a striking and unexpected example of how material properties can change when viewed at the nanoscale,” the article states.

“Superplastic Nanowires Pulled from the Surface of Common Salt”

American Chemical Society

Chinese Women To Gain Management And Leadership Education Through Yale-Tsinghua Partnership

The Yale School of Public Health is partnering with Tsinghua University in Beijing to provide management and leadership education for 500 underserved women in China working in the healthcare field. The partnership, beginning in 2009, is part of the Goldman Sachs 10,000 Women initiative.

Together, Yale and Tsinghua will create a curriculum to build the business and management skills of mid- and senior-level managers in the health sector, particularly in the areas of quality improvement, human resources development, financial management and leadership.

The 10,000 Women initiative is a global effort to provide 10,000 underserved women, predominantly in developing and emerging markets, with business and management education. Goldman Sachs will commit $100 million over the next five years and has partnered with more than 50 universities and organizations in Africa, Asia, Europe, Latin America, the Middle East and United States to seek, create and develop programs to impact the quality and capacity of business education in developing regions around the world.

“The partnership between Tsinghua and Yale will help build strong, effective leaders in the healthcare sector,” said Dina Powell, Managing Director and Global Head of Corporate Engagement at Goldman Sachs. “We are honored to have such prestigious partners join us in the 10,000 Women initiative.”

Elizabeth Bradley, director of Global Health Initiatives at Yale said, “This is a transformational time for China’s health sector with an expanding economy and commitment to high quality health services for all. But policy reforms are less effective unless there is skilled management and strong leadership in health institutions. We hope this program will be a cornerstone in effecting the changes in health quality and equity that China envisions.”

A research report prepared by Goldman Sachs, “Women Hold up Half the Sky,” found that strengthening education for women is a critical and underutilized lever for economic growth in developing and emerging economies. The report concluded that per capita income in China could increase by almost 4 percent with greater labor force participation of women. In countries like India, Egypt, Iran and Turkey, the increase in income per capita could be in excess of 10 percent.

Yale University’s relationship with China is deeper and longer than that of any other university in the United States. Yung Wing, the first person from China to earn a degree from an American college or university graduated from Yale in 1854. Currently, there are 95 faculty-led research projects and other collaborations underway at Yale that are related to or take place in China.

Yale’s participation in the 10,000 Women initiative underscores the University’s long and distinguished commitment to educating leaders and public servants for all sectors of American society, and, increasingly, around the world. For select international partners, Yale offers customized senior leadership programs in the government, business and education sectors, including highly successful programs for presidents of leading universities and for senior government officials.

For further information on the 10,000 Women initiative, please visit www.10000women or contact Joe Snodgrass, Goldman Sachs, 212-902-5400.

Elizabeth Bradley


Community Nurses More Worried About Their Travel Costs Than Their Workload, UK

A survey carried out by the Community District Nursing Association (CDNA) has found that Nurses are being routinely left out of pocket when using their own cars to visit patients. Almost every Nurse questioned, 96.1%, expressed their concern about the cost of using their own vehicle for work and the short-fall between the cost of fuel and the amount they are reimbursed.

In the survey of members across England, Scotland, Wales and Northern Ireland, Nurses claimed to be more concerned about their car costs than their workload.

Fuel costs have increased by an average of 14% each year between January 2006 and January 2008, and this month saw petrol prices rise to 104p. The majority of CDNA members use their own cars to visit patients and have no realistic alternative open to them. Many are funding their employment out of their own pocket by hundreds of pounds each year and are effectively subsidising the running of the National Health Service.

The situation could be set to get even worse, when Chancellor Alastair Darling announces changes to the way in which any employee can claim back their expenses for running a car for work in his Budget on 12th March.

The HMRC’s Authorised Mileage Allowance Payments (AMAPs) are under review and may be reduced in a misguided effort to encourage staff to driver fewer miles. The CDNA is concerned that members will be penalised even further just because of where their patients live and that the AMAPs rates, set back in April 2002 when petrol was 75p a litre, are long overdue for an increase.

Chair of the CDNA, Rowena Smith, comments: “Our members have been concerned for some time that their motoring costs are not being met by their expenses. This survey shows just how bad the situation has become. While we support any reasonable effort to reduce carbon emissions, it must not be done at the expense of nurses or their patients. Nurses along with many other British workers cannot simply change the way they use their cars for work – it is built into their contract and penalising them for not having a company car is nothing short of a stealth tax on employment.”

- Approved Mileage Allowance Payments (AMAPs) allow employees to reclaim the costs of business travel in their own vehicles. The current rates were set in 2002 at 40 pence per mile for the first 10,000 business miles per year and 25 pence per mile thereafter. The AA estimates that between 3 and 5 million employees use their own cars for work.

- The 2007 Budget Report announced that ‘ahead of the Pre-Budget Report, the Government will consider the case for changing the structure of AMAPs to align the tax/NICs treatment and to ensure that rates and thresholds are set at an appropriate level to promote environmentally friendly business travel’. The October Pre-Budget Report however did not contain any changes to AMAPs, instead it announced ‘In advance of the Budget, the Government will continue to consider the representations received from industry’.

- The Community and District Nursing Association (CDNA) is a TUC & STUC affiliated union representing thousands of members, UK wide. The CDNA is the only specialised independent union and association that solely represents community and district nurses.

- Individual nurse case studies relating to personal car use for work are available from the CDNA.

Community & District Nursing Association

Brain Scans Can Give Early Diagnosis Of Different Forms Of Parkinsonism

An article Online First and in the February edition of The Lancet Neurology reports that brain scans using positron emission tomography (PET) can identify with high accuracy which form of Parkinsonism a patient has. Such early diagnosis is essential to make sure that patients receive the correct treatment and do not receive ineffective treatments due to misdiagnosis. The article is the work of Dr David Eidelberg, Center for Neurosciences,The Feinstein Institute for Medical Research, Manhasset, NY, USA, and colleagues.

Parkinson’s disease arising spontaneously can present with symptoms comparable to those of multiple system atrophy or progressive supranuclear palsy. The investigators aimed to assess in this study whether metabolic brain imaging combined with pattern analysis could accurately discriminate patients with different forms of Parkinsonism.

A total of 167 patients were assessed in this study. They were recruited from the New York area between 1998 and 2006. They all had parkinsonian features but uncertain clinical diagnosis. At the Feinstein Institute for Medical Research, all of the patients underwent a PET scan. The team of researchers developed an automated image-based classification procedure to tell apart individual patients with idiopathic Parkinson’s disease, multiple system atrophy, and progressive supranuclear palsy. The likelihood of having each of the three diseases was calculated for each patient. A classification was made according to probability measurements. After imaging, movement disorders specialists who were unaware of the PET results assessed the patients for an average of 2.6 years before a final clinical diagnosis was made. Then, the accuracy of the initial image-based classification was evaluated and compared with the final clinical diagnosis.

Results indicated that image-based classification for idiopathic Parkinson’s disease had 84 percent sensitivity. Sensitivity measures the proportion of actual positives which are correctly identified as such. For instance, it is the percentage of sick people who are identified as having the condition. They had 97 percent specificity which measures the proportion of negatives that are correctly identified. 98 percent had positive predictive value (PPV) which is the proportion of patients with positive test results who are correctly diagnosed. 82 percent had negative predictive value (NPV) which is the proportion of patients with negative test results who are correctly diagnosed. Imaging classifications were also accurate for multiple system atrophy (85 percent sensitivity, 96 percent specificity, 97 percent PPV, and 83 percent NPV) and progressive supranuclear palsy (88 percent sensitivity, 94 percent specificity, 91 percent PPV, and 92 percent NPV). Dr Eidelberg comments: “The excellent specificity and PPV of the imaging classification makes this test suitable for diagnostic use rather than as a screening tool.”

In addition to those findings, the authors indicate that early and correct diagnosis is crucial to make sure that patients with the proper diagnosis are enrolled in drug trials for potentially disease-modifying drugs for the various parkinsonian disorders. Also, the authors wish to expand their work to be able to differentiate other forms of parkinsonism.

They comment: “Automated image-based classification has high specificity in distinguishing between parkinsonian disorders and could help in selecting treatment for early stage patients and identifying participants for clinical trials.”

They note: “Blinded, prospective imaging studies – ideally involving multiple centres, a larger validation group, repeat imaging, and more extensive post-mortem confirmation – are needed to establish the accuracy of this pattern-based categorisation procedure.”

In an associated comment, Professor Angelo Antonini, IRCCS San Camillo, Venice and Parkinson Institute, Milan, Italy, remarks: “The clinical and research relevance of these findings should not be underestimated. Neuroprotective and disease-modifying drug research is intensifying and results mostly rely on accurate early diagnosis.”

He writes in conclusion: “Although imaging might be cost effective for early diagnosis, I expect that these procedures will find their natural application in the identification of suitable candidates for drug trials or complex surgical procedures (eg, deep brain stimulation, stem-cell transplantation, or foetal tissue transplantation). However, additional blinded, prospective, multicentre studies will first be needed to confirm the accuracy of this pattern-based categorisation procedure.”

“Differential diagnosis of parkinsonism: a metabolic imaging study using pattern analysis”
Chris C Tang, Kathleen L Poston, Thomas Eckert, Andrew Feigin, Steven Frucht, Mark Gudesblatt, Vijay Dhawan, Martin Lesser, Jean-Paul Vonsattel, Stanley Fahn, David Eidelberg
DOI: 10.1016/S1474-4422(10)70002-8
The Lancet Neurology

Stephanie Brunner (B.A.)

9,000 University of California Nurses to Strike July 21

In what is believed to be the
largest single strike by registered nurses ever in the United States, some
9,000 University of California RNs have called a one day strike Thursday, July
21 at several of the state’s best known medical institutions, the California
Nurses Association announced today.

In a series of large membership meetings held over the past two weeks, UC
RNs, Nurse Practitioners, and Nurse Anesthetists voted by an overwhelming 95%
to reject a contract proposal by University administrators and authorize the

The strike will affect large UC medical centers in Los Angeles, Santa
Monica, San Diego, San Francisco, Davis, and Irvine, and student health
centers in Riverside, Santa Barbara, Santa Cruz and Berkeley. CNA said that
the University has refused to bargain in good faith provoking the walkout.

At the center of the dispute, said CNA, is the University’s hard line
stance on two issues linked to the high profile attack by Gov. Arnold
Schwarzenegger on nurses in recent months — retirement security and safe

UC plans major cuts in nurses’ retirement plan matching Schwarzenegger’s

Following the governor’s program which attacks those who perform public
service, especially nurses, teachers and firefighters in favor of corporate
privatization, the UC is attempting to undermine retirement security of its
registered nurses. Not only is Schwarzenegger a Regent of the University, but
a UC vice president is also a member of the commission that works with the
governor’s staff on his pension plans.

UC officials have informed CNA that they intend to make substantial
changes in the system’s pension program. In a presentation to top UC managers
at a UC Leadership Institute in May, the system’s top pension and benefit
policy director repeatedly cited the governor’s plan to privatize public
employee pensions, and noted that “pension reform is still on the move.”

In that presentation, UC outlined plans to mandate employees divert 8% of
their pay into the pension system. The UC has failed to make any contributions
to the retirement program since 1990, which, says CNA, is the reason UC is
looking for excuses to penalize employees now.

Nurses note that the University has long cited its retirement program as
an excuse for offering substandard compensation, and warn that the sharp cuts
envisioned by the UC could drive RNs to other hospitals depriving UC patients
of many of its most experienced RNs.

“Historically, UCLA has justified their lack of pay competitiveness [as a
trade-off for the UC pension plan],” says Michael Kenny, an RN at the UCLA
Medical Center’s Neuropsychiatric Institute. “UCLA is no longer an employer of
choice for Los Angeles nurses. Nurses are ‘voting’ with their feet by
leaving. Other hospitals in the area now offer retirement plans that allow
the nurse to retire with dignity.”

CNA is proposing language to guarantee there will be no changes in the
nurses’ pension, retiree health, or other benefits for the life of the
contract, as all other large health systems have done in contracts with CNA.

UC officials want to continue to be able to make cuts in retirement and
benefits any time, and in addition to its pension changes has also indicated
plans to reduce retiree health benefits and make employees pay far more for
health benefits.

“Throughout bargaining and inside the UC hospitals and clinics, nurses are
feeling unheard,” said UCSF nurse negotiator Maureen Dugan, RN. “Failure to
listen to what nurses need to care for their patients and families will lead
to a revolving door of inadequate care at world famous UC medical centers.”

“Experienced nurses will leave the UC system if they cannot trust UC to
provide working conditions, pensions, healthcare, and safe staffing for
patients,” said UC Davis RN Suzanne DePalma. “Leaving inexperienced nurses and
doctors in UC hospitals without the needed support of expert RNs, would be
unsafe for the patients who are desperately ill, vulnerable, and trusting
nurses and doctors to take good care of them.”

Schwarzenegger re-files attack on RN ratios as UC refuses to bargain

Safe staffing is another key flashpoint. At the request of the California
Hospital Association, the lobbying arm of the hospital industry of which the
UC administration is a major part, Schwarzenegger issued an emergency order
last year to roll back key portions of the safe RN-to-patient staffing ratio

While a Sacramento Superior Court overturned the emergency order last
month, the Schwarzenegger administration filed an identical emergency order
last week as part of its plan to appeal the court decision.

CNA has introduced a comprehensive UC staffing proposal, emulating the
specific minimum ratios required by the law, which would be enforced through
the contract. UC management has refused to bargain on the issue.

UC facilities frequently fail to meet the staffing needed to handle the
especially ill patients commonly found in UC hospitals, and the UC
administration has conceded that its acuity systems, used for improving
staffing beyond the ratios for the sickest patients, are in many areas based
on budget priorities rather than patient need.

“Nurses are sending a strong message that UC should address the nursing
shortage by including in the CNA contract nurse-to-patient safe staffing
ratios, competitive wages, health insurance and pension protections because in
health or sickness, patients deserve the best qualified experienced RNs
around,” said UC Irvine RN Tam Nguyen, one of four UCI RN leaders who was
suspended by the University in retaliation after the strike vote was
announced, an illegal act, says CNA, that further inflamed tensions between
the University and the nurses.

The nurses and UC administration also remain divided on wages because UC
compensation is far below salaries at other hospitals, on a CNA proposal to
safeguard patients and RN practice when new technologies are introduced, and
on a UC demand that would force nurses to work when sick, endangering
patients, or lose vacation time.

“UCSD is a hospital which provides care to a large community which extends
far beyond San Diego. They provide many treatments that cannot be found
elsewhere. This requires very experienced RN staff. In order to retain
experienced staff, UCSD needs to provide competitive wages,” said Janice Webb,
a UC San Diego RN.

California Nurses Association

Bubble Wrap Saves Preterm Baby’s Life, UK

An extremely preterm baby girl survived against the odds after being kept warm in bubble wrap.

After cutting the umbilical cord, staff at Worcestershire Royal Hospital in the UK put the baby girl in a small plastic bag enclosed in bubble wrap and warned her
parents that her chances of survival were not good.

But Lexi Lacey, who weighed just 14 oz (397 gm) when she was born after only 26 weeks gestation, defied the odds, she is now a
healthy 11-week old baby, despite weighing just 5 lb 6 oz, two pounds lighter than the average full-term baby.

Dr Andrew Gallagher, A consultant paediatrician at the hospital told the Daily Mail that it was normal to wrap very small
newborns in plastic “to keep them warm they are placed in a plastic bag for about 30 minutes,” he said.

Parents Chelsea Rowberry, 17, and Lee Lacey, 24, said that when people see Lexi they can’t believe how premature she was.

Rowberry said she was staying at her brother’s when she started feeling contractions, late one Sunday in June. She said she rang
the maternity unit but they just told her to go to sleep.

So she rang her mother who immediately called an ambulance. She said she was frightened because she thought she was having a

When she got to the hospital they told her she was 3 cm dilated and she gave birth to Lexi.

Soon afterwards, the hospital staff put Lexi in the bubble wrap plastic bag.

Gallagher said they put the premature babies into the bag feet first leaving just the head outside. This stops water evaporating
easily off their bodies, which would cause them to lose heat quickly in those vital first minutes of life before they get to the incubator.

The babies are then transferred to the neonatal unit where they are placed in an incubator and taken out of the bag.

He said the bags are about the same size as a sandwich bag, and they “come from NHS supplies and are on a roll”.

Although her mother was able to go home on the same day she was born, little Lexi was transferred to
Birmingham’s Heartlands Hospital and then to Shrewsbury Royal Hospital to receive specialist care. She eventually returned to
Worcestershire Royal.

Lexi’s parents were very scared she would not survive. Rowberry said they would get calls from the hospital like Lexi “needed a
blood transfusion and she probably wouldn’t make it through the night”.

Although her baby has been given the all clear, Rowberry said she is still scared because Lexi is so tiny. She is the most
premature baby to survive at the hospital.

A premature baby is born before the 37th week of pregnancy. A baby born between 35 and 37 weeks is described as moderately
pre-term, between 29 and 34 weeks as very pre-term, and between 24 and 28 weeks, as extremely pre-term.

A low birthweight baby weighs less than 1.5 kg (5.5 lbs), while an extremely low birthweight baby weighs less than 1.0 kg (2.2
lbs). Lexi weighed less than half of this when she was born.

Because they are born too early, premature babies often have health problems because their organs are undeveloped. As a result
they can be at higher risk for a range of problems such as breathing difficulties and serious lung conditions like respiratory
distress syndrome, cerebral palsy, life-threatening infections, and learning and development disabilities.

In England and Wales nearly 8 per cent, that is 1 in 13 live births are pre-term, with 93 per cent of them occuring after 28 weeks
of pregnancy, 6 per cent between 22 and 27 weeks and just under 1 per cent before 22 weeks.

A study of babies born before 26 weeks in the UK and Ireland in the mid-1990s (the EPICure study) showed that 81 per cent of
those born at 24 weeks survived, whereas only half of those born at 22 weeks survived.

The study also found, when it re-examined the children at age 11, that those born earlier than 26 weeks of pregnancy had lower
scores for cognitive ability, reading and mathematics.

In the US, the incidence of pre-term live births appears to have increased: it was nearly 13 per cent in 2005, which is significantly
higher than the 5 to 10 per cent of other resource-rich countries.

Sources: Daily Mail, Tommy’s, Medline Plus.

: Catharine Paddock, PhD

Augurex Reports Positive Data For RA Blood Test And Drug Target At The Annual European Congress Of Rheumatology (EULAR)

Augurex Life Sciences Corp. reported that in London at the European League Against Rheumatism (EULAR) Conference, leading arthritis researchers presented important data on Augurex’s rheumatoid arthritis (RA) biomarker blood test and novel drug target.

RA is a disease that affects approximately 10 million people worldwide; however, it can be difficult for a primary care physician to diagnose because the joint pain symptoms are common to other conditions. This often delays RA patient referral to an arthritis specialist where they could otherwise receive therapies to treat or possibly halt the disease. RA is a particularly debilitative form of arthritis that, if left untreated, results in 70% of patients developing irreversible joint damage within 2 years of symptom onset.

This blood test measures 14-3-3, a protein that is elevated in the blood of patients with RA while it is relatively absent in healthy people and those with other types of auto-immune conditions. The 14-3-3 protein was evaluated in 135 RA patients and 130 controls showing that if patients were positive for the protein, they had a 5 to 50 times greater likelihood of having RA and that its levels were independent of another commonly used blood test called Rheumatoid Factor or RF. What this means is that 14-3-3 may be combined with other blood tests to accurately capture at least 87% of patients with RA.

“The real focus in RA these days is to ensure that patients are identified, ideally early in the course of disease, so that they can get on appropriate treatments that may significantly improve their short and long-term outcome. What we are seeing in the data is that a blood test like this one, could assist in identifying more patients that may have gone longer before being diagnosed”, says Dr. Walter Maksymowych who is the lead investigator on this study, co-discoverer of 14-3-3 in arthritis and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada.

Other data presented by Dr. Maksymowych at EULAR, described what 14-3-3′s biological role could be in the development of inflammatory arthritis. Although the protein normally exists inside of healthy cells, in RA it is externalized and acts back on cells activating key intracellular pathways causing harmful substances such as, TNF-О±, IL-6, RANKL and MMP-9 to be produced which in turn cause inflammation and joint damage. Antibody compounds targeted at the 14-3-3 protein were shown to block its disease-related effects in cells. The uniqueness of the 14-3-3 protein is that it’s not only measurable in blood to help identify patients with RA but it seems that if you reduce its harmful biological effects with antibodies or other drugs that could inactivate this protein you may be able to treat the disease.

In RA, not unlike cancer, the development of the disease includes multiple factors that act to varying degrees in different patients. Therefore, in multi-factorial diseases like RA, targeted therapies are highly desirable that focus on the most prominent disease contributors in individual patients. “If you have a direct companion diagnostic blood test that can specifically identify patients who most need the therapy and that also gives you an indication of how well the drug is working, that’s the ideal therapeutic management scenario”, states Dr. Maksymowych.

If the continued development efforts of the drug are successful then this protein may represent the first “personalized medicine” target in rheumatology. The way this would work is that, in patients who have very little, or no 14-3-3 you would not treat them with the drug that targets the protein, while in those who have higher levels, you can dose them with the appropriate amount of anti-14-3-3 drug to remove it from the body and use the blood test to monitor their response over time.

Source: Augurex Life Sciences Corp.