Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that an independent data
monitoring committee (DMC) has completed a second planned interim analysis
of data from the Company's pivotal Phase 3 ENRICH trial of EFAPROXYN(TM)
(efaproxiral) plus whole brain radiation therapy (WBRT) in women with brain
metastases originating from breast cancer, and has recommended that the
trial continue to the final efficacy analysis. The interim analysis was
triggered by the occurrence of 188 patient deaths and was based upon an
evaluation of patients randomized through July 31, 2006. In order to
protect the integrity of the trial, the results of the efficacy analysis
will not be made available to the Company until the study is completed. No
major patient safety concerns were identified by the DMC.



"This recommendation represents continued progress toward the
completion of the ENRICH trial and further confirmation of EFAPROXYN's
favorable safety profile," said Paul Berns, Allos' President and Chief
Executive Officer. "We are grateful for the support received from our
investigators, patients and employees who enabled us to reach this
milestone, and look forward to conducting the final efficacy analysis
following the occurrence of 282 patient deaths, which we currently expect
to occur in mid-2007."



The Phase 3 ENRICH trial (ENhancing whole brain Radiation therapy In
patients with breast Cancer and Hypoxic brain metastases) is a randomized,
open-label, multi-center study designed to evaluate the safety and efficacy
of WBRT with supplemental oxygen with or without EFAPROXYN in women with
brain metastases originating from breast cancer. Patient enrollment in the
trial was completed in August 2006, with a total of 368 patients enrolled
at 78 medical centers in the United States, Canada, Europe and South
America. The primary endpoint of the trial is survival. Secondary endpoints
include response rate in the brain at three months, Karnofsky Performance
Status, and neurologic signs and symptoms assessment. The trial is being
conducted under a Special Protocol Assessment, which is an agreement
between the Company and the U.S. Food and Drug Administration (FDA) that
the design and planned analyses of the study, as reflected in the trial
protocol, adequately address the objectives of the study in support of a
new drug application.



Next Milestones



The Company will conduct the final analysis of safety and efficacy data
from the ENRICH trial following the occurrence of 282 patient deaths, which
is currently expected to occur in mid-2007. If the trial is deemed to be
positive at the final analysis, the Company intends to submit an amendment
to its previously filed new drug application (NDA) to the FDA to seek
marketing approval for EFAPROXYN for use as an adjunct to radiation therapy
for the treatment of brain metastases originating from breast cancer.
















About the Data Monitoring Committee



The DMC is comprised of independent medical experts and statisticians
and was established by Allos as part of the Company's compliance with good
clinical practice guidelines. The DMC is responsible for monitoring the
safety of patients participating in the ENRICH trial and for conducting
interim analyses of trial results to assess the safety and efficacy of
EFAPROXYN.



About Brain Metastases Originating from Breast Cancer



According to the American Cancer Society, brain metastases occur in
approximately 175,000 patients per year in the United States. WBRT is the
current standard of care for the treatment of brain metastases, and is
administered to approximately 125,000 patients per year in the United
States as a means to prevent or reduce complications and extend survival.
Cancers that metastasize to the brain most often originate in the breast,
lungs, kidneys or melanoma in the skin. Breast cancer is the second most
common cause of brain metastases, accounting for 15% to 20% of the total
incidence of brain metastases. The median survival of women with brain
metastases originating from breast cancer who receive WBRT is approximately
4.6 months.



About EFAPROXYN



EFAPROXYN is the first synthetic small molecule designed to sensitize
hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by
facilitating the release of oxygen from hemoglobin, the oxygen-carrying
protein contained within red blood cells, and increasing the level of
oxygen in tumors. The presence of oxygen in tumors is an essential element
for the effectiveness of radiation therapy. By increasing tumor
oxygenation, EFAPROXYN has the potential to enhance the efficacy of
standard radiation therapy.



Based on the findings from a prior Phase 3 trial of EFAPROXYN in
patients with brain metastases, in December 2003 the Company submitted an
NDA to the FDA to seek approval to market EFAPROXYN in the United States as
an adjunct to WBRT for the treatment of patients with brain metastases from
breast cancer. In June 2004, the FDA issued an "approvable letter" in which
it indicated that the NDA may be approved if the Company successfully
completes the ENRICH trial and submits the results as an NDA amendment for
the FDA's review.



EFAPROXYN Safety Profile



EFAPROXYN has a well established safety profile. To date, approximately
900 patients have been treated with EFAPROXYN in conjunction with radiation
therapy in 12 clinical trials, including ENRICH. The results have shown
that EFAPROXYN is generally well tolerated and has an acceptable safety
profile for use in cancer patients. Adverse events observed to date in the
ENRICH study appear to be similar to those observed in previous clinical
trials with EFAPROXYN.



About Allos Therapeutics, Inc.



Allos Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused
on the development and commercialization of small molecule therapeutics for
the treatment of cancer. The Company has two product candidates in
late-stage clinical development: EFAPROXYN (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in women
with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel, next generation antifolate currently under
evaluation in a pivotal Phase 2 trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The Company is also evaluating RH1,
a targeted chemotherapeutic agent, in a Phase 1 trial in patients with
advanced solid tumors. For additional information, please visit the
Company's website at allos/.



Safe Harbor Statement



This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include statements
concerning the Company's projected timeline for conducting the final
analysis of safety and efficacy data from the ENRICH trial, the Company's
intent to submit an amendment to its previously filed NDA if the ENRICH
trial is deemed to be positive at the final analysis, the potential safety
and efficacy of EFAPROXYN for the treatment of patients with brain
metastases originating from breast cancer, and other statements which are
other than statements of historical facts. In some cases, you can identify
forward-looking statements by terminology such as "may," "will," "should,"
"expects," "intends," "plans," anticipates," "believes," "estimates,"
"predicts," "projects," "potential," "continue," and other similar
terminology or the negative of these terms, but their absence does not mean
that a particular statement is not forward- looking. Such forward-looking
statements are not guarantees of future performance and are subject to
risks and uncertainties that may cause actual results to differ materially
from those anticipated by the forward-looking statements. These risks and
uncertainties include, among others: that the Company may experience
difficulties or delays in the ENRICH trial, whether caused by adverse
events, regulatory issues or other factors; and that the ENRICH trial may
not demonstrate the safety and efficacy of EFAPROXYN for the treatment of
brain metastases from breast cancer. Even if the ENRICH trial demonstrates
the safety and efficacy of EFAPROXYN, regulatory authorities may not
approve EFAPROXYN for the treatment of patients with brain metastases
originating from breast cancer, the Company may not be able to successfully
market EFAPROXYN, or the Company may face post-approval problems that
require the withdrawal of EFAPROXYN from the market. Additional information
concerning these and other factors that may cause actual results to differ
materially from those anticipated in the forward-looking statements is
contained in the "Risk Factors" section of the Company's Annual Report on
Form 10-K for the year ended December 31, 2005, and in the Company's other
periodic reports and filings with the Securities and Exchange Commission.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. All
forward-looking statements are based on information currently available to
the Company on the date hereof, and the Company undertakes no obligation to
revise or update these forward-looking statements to reflect events or
circumstances after the date of this presentation, except as required by
law.


Allos Therapeutics, Inc.

allos/

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Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the
European Commission has approved TORISEL(TM) (temsirolimus) for the
first-line treatment of patients with advanced renal cell carcinoma (RCC)
who have at least three of six prognostic risk factors. TORISEL is the only
approved cancer therapy that specifically inhibits the mTOR (mammalian
target of rapamycin) kinase, an important regulator of cell proliferation,
cell growth and cell survival. TORISEL was approved in the United States in
May 2007 for the treatment of advanced RCC.


Renal cell carcinoma accounts for approximately 85 percent of the
estimated 85,000 new cases of kidney cancer diagnosed in Europe annually.
TORISEL is the only renal cancer therapy proved to extend median overall
survival compared with interferon-alpha in patients with advanced RCC.



"Temsirolimus was studied in the most difficult-to-treat patients with
advanced renal cell carcinoma: those who have multiple risk factors that
have been associated with shortened survival," says Bernard Escudier, M.D.,
Head of the Immunotherapy Unit, Department of Medical Oncology, Institut
Gustave Roussy, Villejuif, France, and an investigator in the TORISEL phase
3 study. "The ability of temsirolimus to provide an increase in overall
survival in these patients provides us with a much-needed new option for
the treatment of advanced kidney cancer."



TORISEL was studied in a three-arm, phase 3 clinical trial of 626
patients with advanced RCC and three or more of six preselected prognostic
risk factors who had received no prior systemic therapy. In the study,
TORISEL significantly increased median overall survival by 49 percent
compared with interferon-alpha (10.9 months vs. 7.3 months, P=0.0078).
TORISEL also was associated with a statistically significant improvement
over interferon-alpha in the secondary endpoint of progression-free
survival (when the disease does not worsen; 5.6 months vs. 3.2 months,
P=0.0042). The combination of TORISEL and interferon-alpha did not result
in a significant increase in overall survival when compared with
interferon-alpha alone.



"The European Commission's approval of TORISEL underscores the
importance of this therapy for patients with advanced kidney cancer and
reinforces the potential of this mechanism of action as a new approach in
oncology," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research,
and Senior Vice President, Wyeth.



About TORISEL



TORISEL is an mTOR inhibitor indicated in the European Union for the
first-line treatment of patients with advanced RCC who have at least three
of six prognostic risk factors. These risk factors include less than one
year from time of initial RCC diagnosis to randomization, Karnofsky
performance status of 60 or 70, hemoglobin less than the lower limit of
normal, corrected calcium of greater than 10 mg/dL, lactate dehydrogenase >
1.5 times the upper limit of normal, and more than one metastatic organ
site. In the United States, TORISEL is indicated for the treatment of
advanced RCC.
















Inhibition of mTOR in treated cancer cells blocked the translation of
genes that regulate the cell cycle. In in vitro studies using renal cancer
cell lines, TORISEL inhibited the activity of mTOR and resulted in reduced
levels of certain cell growth factors involved in the development of new
blood vessels, such as vascular endothelial growth factor.



In March 2007, the European Association of Urology published guidelines
recommending that TORISEL be considered as first-line treatment in patients
with advanced RCC with poor-risk features. In August 2007, the National
Comprehensive Cancer Network (NCCN) in the United States added TORISEL to
the NCCN Kidney Cancer Guidelines as an option in first-line therapy for
both predominant clear cell histology and non-clear cell histology and as a
subsequent therapy option for patients with predominant clear cell
histology.



TORISEL U.S. Important Safety Information



Hypersensitivity reactions manifested by symptoms, including, but not
limited to anaphylaxis, dyspnea, flushing, and chest pain have been
observed with TORISEL.



Serum glucose, serum cholesterol, and triglycerides should be tested
before and during treatment with TORISEL.



The use of TORISEL is likely to result in hyperglycemia and
hyperlipemia. This may result in the need for an increase in the dose of,
lipid-lowering agents, respectively.



The use of TORISEL may result in immunosuppression. Patients should be
carefully observed for the occurrence of infections, including
opportunistic infections.



Cases of interstitial lung disease, some resulting in death, have
occurred. Some patients were asymptomatic and others presented with
symptoms. Some patients required discontinuation of TORISEL and/or
treatment with corticosteroids and/or antibiotics.



Cases of fatal bowel perforation occurred with TORISEL. These patients
presented with fever, abdominal pain, metabolic acidosis, bloody stools,
diarrhea, and/or acute abdomen.



Cases of rapidly progressive and sometimes fatal acute renal failure
not clearly related to disease progression occurred in patients who
received TORISEL.



Due to abnormal wound healing, use TORISEL with caution in the
perioperative period.



Patients with central nervous system tumors (primary CNS tumor or
metastases) and/or receiving anticoagulation therapy may be at an increased
risk of developing intracerebral bleeding (including fatal outcomes) while
receiving TORISEL.



Live vaccinations and close contact with those who received live
vaccines should be avoided.



Patients and their partners should be advised to avoid pregnancy
throughout treatment and for 3 months after TORISEL therapy has stopped.



The most common (incidence greater than or equal to 30%) adverse
reactions observed with TORISEL are: rash (47%), asthenia (51%), mucositis
(41%), nausea (37%), edema (35%), and anorexia (32%). The most common
laboratory abnormalities (incidence greater than or equal to 30%) are
anemia (94%), hyperglycemia (89%), hyperlipemia (87%), hypertriglyceridemia
(83%), elevated alkaline phosphatase (68%), elevated serum creatinine
(57%), lymphopenia (53%), hypophosphatemia (49%), thrombocytopenia (40%),
elevated AST (38%), and leukopenia (32%).



Most common grades 3/4 adverse events included asthenia (11%), dyspnea
(9%), hemoglobin decreased (20%), lymphocytes decreased (16%), glucose
increased (16%), phosphorus decreased (18%), and triglycerides increased
(44%).



Strong inducers of CYP3A4/5 (eg, dexamethasone, rifampin) and strong
inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may decrease and
increase concentrations of the major metabolite of TORISEL, respectively.
If alternatives cannot be used, dose modifications of TORISEL are
recommended.



St. John's Wort may decrease TORISEL plasma concentrations, and
grapefruit juice may increase plasma concentrations of the major metabolite
of TORISEL, and therefore both should be avoided.



The combination of TORISEL and sunitinib resulted in dose-limiting
toxicity (Grade 3/4 erythematous maculopapular rash, and gout/cellulitis
requiring hospitalization).



Please see TORISEL full U.S. Prescribing Information at
TORISEL.



Wyeth Pharmaceuticals



Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products.



Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceutical, vaccines,
biotechnology products and non-prescription medicines that improve the
quality of life for people worldwide. The Company's major divisions include
Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.



The statements in this press release that are not historical facts are
forward-looking statements based on current expectations of future events
and are subject to risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such statements.
These risks and uncertainties include the inherent uncertainty of the
timing and success of, and expense associated with, research, development,
regulatory approval and commercialization of our products, including with
respect to our pipeline products; government cost-containment initiatives;
restrictions on third-party payments for our products; substantial
competition in our industry, including from branded and generic products;
data generated on our products; the importance of strong performance from
our principal products and our anticipated new product introductions; the
highly regulated nature of our business; product liability, intellectual
property and other litigation risks and environmental liabilities;
uncertainty regarding our intellectual property rights and those of others;
difficulties associated with, and regulatory compliance with respect to,
manufacturing of our products; risks associated with our strategic
relationships; economic conditions including interest and currency exchange
rate fluctuations; changes in generally accepted accounting principles;
trade buying patterns; the impact of legislation and regulatory compliance;
risks and uncertainties associated with global operations and sales; and
other risks and uncertainties, including those detailed from time to time
in our periodic reports filed with the Securities and Exchange Commission,
including our current reports on Form 8-K, quarterly reports on Form 10-Q
and annual report on Form 10-K, particularly the discussion under the
caption "Item 1A, RISK FACTORS." The forward-looking statements in this
press release are qualified by these risk factors. We assume no obligation
to publicly update any forward-looking statements, whether as a result of
new information, future developments or otherwise.


Wyeth Pharmaceuticals

wyeth


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Cygenics (ASX: CYN) announce the first cystic fibrosis cord blood collection. Clinical history was made at The Mercy Hospital in Werribee on Easter Saturday, when baby Aiden Brundell donated his cord blood in the hope that his precious stem cells could one day rejuvenate sister Mikaela's lungs, which are failing from cystic fibrosis (CF), and save her life.


This first collection of cord blood from the sibling of a child with CF is a major step towards treating the deadly effects of Australia's most common severe genetic condition among children, for which there is no cure.


Aiden's cord blood collection and storage was free of charge, thanks to a generous donation by private cord blood bank, Biocell Pty Ltd and its parent company CyGenics Ltd.


Professor Bob Williamson, spokesperson for Cystic Fibrosis Victoria, said the fantastic generosity of Biocell and CyGenics to Cystic Fibrosis Australia could extend to collecting as many as 36 cord bloods over three years for families with cystic fibrosis in Australia and New Zealand. This represents a commitment valued at more than A$100,000 (approximately US$75,000) over the three years.


Professor Williamson said, "Everyone agrees that the use of cells from cord blood poses no ethical problems. They are adult stem cells, but because they are taken at birth they are far more flexible and grow more easily than most such cells."


He added "Cord blood stem cells represent a real glimmer of hope for cystic fibrosis sufferers, with their potential to physically rebuild lungs previously considered damaged beyond repair."


"The latest research in Australia, Germany and the United States shows that stem cells from cord blood can give cells that are very similar to lung cells. In a mouse model for cystic fibrosis, the cells help to cure the disease. And here in Melbourne, at The Alfred Hospital, it has been shown that when lungs are transplanted into patients, they appear to take up stem cells from the recipient and integrate them into the airways."


Mr Ian Brown, Managing Director of BioCell and Chief Operating Officer of CyGenics said, "This is an exciting initiative for BioCell to be involved in. The therapeutic potential for stem cells, in not only cystic fibrosis applications, are looking very promising."


Professor Williamson concluded, "There are about one million Australians who are healthy carriers of the cystic fibrosis gene. Carriers are completely healthy, but if two carriers have a child, there is a one in four chance that the baby will be affected by cystic fibrosis. Despite a baby being born with CF in Australia every four days, over 90% of parents are unaware they are healthy carriers of the deadly gene."


"Medical researchers, with the support of the Australian Cystic Fibrosis Research Trust, are working tirelessly to find a cure for cystic fibrosis. The collection and storage of cord blood stem cells represents a real investment in hope for cystic fibrosis sufferers like Mikaela Brundell. The research is under way to use these stem cells in the future in an ethical way, to improve the quality and longevity of Mikaela's life."















About Cystic Fibrosis


Cystic fibrosis (CF) is Australia's most common life shortening genetic condition. Sadly there is no cure. Many children with CF used to die in early childhood, but recent advances in treatment have extended life expectancy to 30 years and more.


CF primarily affects the lungs and digestive system, and causes a build up of thick sticky mucus in the body resulting in repeated lung infections and poor digestion. To keep healthy, people with CF must receive chest physiotherapy several times a day to keep their lungs free of mucus and consume enzyme tablets with each meal to help them digest their food. Regular antibiotic treatment and periods of hospitalisation are often required.


Approximately 3000 Australians have CF and a further one million others are healthy carriers of the defective cystic fibrosis gene. If two carriers met and have a child there is a one in four chance for each pregnancy that the child will be affected by cystic fibrosis. In Australia, 1 in every 2500 births results in a child with CF.


For further information about CF please visit: cfv.au or cysticfibrosis.au


CytoVations (new product development) based in New Jersey, USA. CyGenics is listed on the Australian Stock Exchange, under the symbol CYN. For more information, please visit cygenics.


About CYGENICS LIMITED


CyGenics is a cell therapy company focused on the development and commercialisation of adult stem cell-related products, services, applications and technologies.


From its headquarters in Australia, CyGenics operates four subsidiaries:

Singapore-based CordLife (tissue banking services, in particular, cord blood banking) and Cell Sciences (consumable cell culture products), and Cytomatrix (cell therapeutics and technology development) based in Boston, USA, and CytoVations (new product development) based in New Jersey, USA. CyGenics is listed on the Australian Stock Exchange, under the symbol CYN.
For more information, please visit cygenics.


Copyright © 2006 ACN Network. A division of Asia Corporate News Network. All rights reserve asiacorpnet

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Results of an expanded, bold clinical trial that treats heart attack patients with a reduced-dose, clot buster in the back of an ambulance en route to a hospital has led to a new discovery by researchers at The University of Texas Health Science Center at Houston (UTHealth): giving the drug can lessen the time the heart suffers damage to under two hours, significantly improving outcome.


"We've known for a while that after the first three hours of a heart attack, much of the damage is already done. But more recent data is making it clearer that it's really the first two-hour period that is most critical ," said James J. McCarthy, M.D., assistant professor of emergency medicine at the UTHealth Medical School and director of the Emergency Center at Memorial Hermann-Texas Medical Center. "In this study, we compared how many patients we could treat in the first two hours compared to conventional strategies. What we found is that very few patients could be treated in the first two hours without initiating treatment before they arrived in the hospital, and by doing so we could decrease the amount of heart damage that occurs."


McCarthy presented the latest results of the study, "A Coordinated Pre-Hospital Initiated Thrombolytic Strategy Coupled with Urgent PCI Dramatically Reduces Time to Treatment for STEMI Patients," on Nov. 13, 2010 during the 2010 American Heart Association's (AHA) Scientific Sessions Conference in Chicago. This research, a collaboration of UTHealth, Memorial Hermann Heart & Vascular Institute-Texas Medical Center and the Houston Fire Department, builds on a previous smaller study.


"If they wait an hour to call 911 the national average is two hours and it takes another hour for them to get to the hospital, they are already outside that two-hour mark," McCarthy said. "Even at top performing hospitals, it can take 50 minutes to get treated. The AHA standard is 90 minutes. We are discovering more and more that time is heart."


During a heart attack, an artery to the heart is blocked. The heart muscle does not die immediately, but the likelihood of debilitating damage and death goes up the longer the artery stays blocked. Physicians including cardiology pioneers at UTHealth discovered 30 years ago that the artery could be opened quickly by delivering a clot-buster (a thrombolytic medicine) into the affected artery via a catheter.


The UTHealth study, called Pre-Hospital Administration of Thrombolytic Therapy with Urgent Culprit Artery Revascularization (PATCAR), takes treatment a step further by giving the patient a lower dose of a clot-busting drug intravenously (IV) before they arrive at the hospital. Early results published in 2008 showed that in 82 percent of patients who received the IV drug in the ambulance, the artery was already partially re-opened. In addition, the size of the heart attack was reduced by 50 percent and there was a 50 percent reduction on mortality. That study included 73 patients.


The most recent results included a total of 314 patients. Of those, 278 were treated with pre-hospital, clot-busting medication. The remaining 36 were ineligible for the medication and became the control group. The time to treatment initiation within two hours was 74 percent of the pre-hospital medication group versus just 17 percent of the non-pre-hospital medication group.


"Results from this larger group of patients also relieved worries about complications of giving the clot-buster, such as strokes and bleeding, which were not more likely to occur," McCarthy said. "We are hopeful that further randomized testing will reveal that this could result in a new standard of care for heart attack patients."

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An inhaled immune system stimulant protects mice against lethal pneumococcal pneumonia and other deadly bacterial, viral and fungal infections of the lungs, a research team led by scientists at The University of Texas M. D. Anderson Cancer Center reports at a major scientific meeting.


Their findings have implications for protecting immuno-compromised patients against infection and the general public against respiratory epidemics and biological weapons. The research is a featured presentation at the annual meeting of the American Society for Cell Biology Dec. 3 in Washington, D.C.


"This aerosol stimulates an innate immune system response in the lung lining fluid that kills the invading pathogens virtually on contact," says Brenton Scott, Ph.D., post-doctoral fellow in M. D. Anderson's Department of Pulmonary Medicine, and first author of the abstract presented at ASCB. "It also works in mice with suppressed immune systems."


The innate immune system is the body's inflammatory first response to infection or injury. It produces proteins and peptides that act as natural antibiotics to broadly kill invading bacteria, viruses or fungi.


"Pneumonia is a leading cause of death from infection in the United States and a major cause of death among cancer patients and others with suppressed immune systems," says Burton Dickey, M.D., professor and chair of pulmonary medicine and senior author of the research.


Untreated mice exposed to S. pneumoniae, the most common form of bacterial pneumonia, died within days. Mice treated with the Aerosolized Lung Innate Immune Stimulant (ALIIS), developed by the researchers, two hours before exposure had an 83 percent survival rate. All of the mice treated between 4 and 24 hours before exposure survived.


The effect slowly declines over five days, Scott says. Giving the stimulant after infection also provides some protection.


The team got similar results testing ALIIS as a protectant against lethal doses of several other types of pneumonia, as well as influenza virus, the mold aspergillus, and the Class A bioterror agents anthrax, bubonic plague, and tularemia.


ALIIS consists of a purified extract of a common bacterium, Haemophilus influenzae, that causes ear and sinus infections in children. The bacterium is essentially broken open, purified and administered as an aerosol.


Preclinical research continues, with early clinical trials most likely to test a protective role in cancer patients - at least a year away.


The innate immune system indiscriminately targets invading pathogens and also recruits the adaptive immune system to launch a more targeted, pathogen-specific response. The adaptive immune system takes a few days to respond, Dickey says.















"Here the innate immune system is so effective, infections are cleared before the adaptive response even gears up," Dickey says.


The battle also is over before white blood cells called neutrophils, part of the innate immune system, can be called in to help. That's potentially important, Dickey says, because chemotherapy, particularly for leukemia, often wipes out a patient's neutrophils.


Dickey and Scott believe the entire defense against invaders is accomplished by local cells in the lung's lining, called the epithelium. Their research shows the epithelium floods its lining fluid with anti-microbial polypeptides in response to ALIIS inhalation. These natural antibiotics are virtually lying in wait for microbes to kill.


The team is now trying to understand exactly which of these polypeptides kills the pathogens.


Lungs are exposed to infectious agents with every breath, Scott notes, and the innate immune system plays an important role in routinely keeping the lungs healthy.


"We study airway inflammation, and mostly we think about that in a negative context - how to stop inflammation, as in the allergic inflammation that causes asthma," says Dickey. "But surely the ability of airways to become inflamed is there for a good reason. So we asked can we set off a type of inflammation that strengthens protection against infection. The answer is yes."


Research is funded by the George and Barbara Bush Endowment for Innovative Cancer Research, M. D. Anderson's Odyssey Fellowship program, and grants from the National Institutes of Health, National Heart, Lung and Blood Institute.


Dickey and others involved in the research have a patent on ALIIS. Dickey, Scott and co-author Michael Tuvim, Ph.D., associate professor in the Department of Pulmonary Medicine, own stock in Pulmotect, LLC, which has licensed the ALIIS technology from M. D. Anderson. These arrangements are managed in accordance with M. D. Anderson's conflict of interest policies.


Co-authors with Scott, Dickey and Tuvim are Cecilia Clement, M.D., and Scott Evans, M.D., both of M. D. Anderson's Department of Pulmonary Medicine; Bryan E. Gilbert, Ph.D. of Baylor College of Medicine's Department of Molecular Virology and Microbiology; and Johnny Peterson, Ph.D., The University of Texas Medical Branch at Galveston Department of Microbiology and Immunology.


University of Texas M. D. Anderson Cancer Center

1515 Holcombe Blvd., Box 229

Houston, TX 77030

United States

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While Ginseng has been a busy little herb these last few thousand years, cinnamon has recently been found to pack a powerful medicinal punch. A tasty addition to hot chocolate and apple pie, nutritionists agree this popular spice offers surprising benefits for those suffering from diabetes.


"Good medicine doesn't always take the form of a pill. Sometimes the answer, or part of the answer, can be found in your kitchen cabinet," says Dr. Richard Goldfarb, the medical director for the Bucks County Clinical Research Center. Dr. Goldfarb is working with eFoodSafety, a biotech company based in Arizona that develops nutraceuticals and whole food products. The company's Cinnergen®, a concentrated liquid extract of cinnamon and other natural synergistic ingredients, is used for promoting healthy blood sugar levels in diabetics and prediabetics.


The strongest evidence yet in favor of cinnamon being used as an all-natural diabetes supplement comes from a recent study conducted in Pakistan. Participants took between one and six grams of cinnamon each day for forty days, while others took equivalent amounts of a placebo. Those taking cinnamon saw significant improvements in their blood sugar, cholesterol, and triglyceride levels, even after discontinuing treatment.


The survey, which asked participants to describe what they had eaten in the last twenty-four hours, found more than 40% had not eaten a single piece of fruit, 20% had not eaten one vegetable, 55% had eaten red meat, and more than 44% had eaten at least one serving of luncheon meat or bacon that day. Results such as these suggest that while the message of good nutrition is omnipresent, people aren't practicing what they preach.


"When we strip away all the research, studies, clinical experiences, and case histories, we are left with one fundamental, inescapable fact: we are what we eat," says Dr. Goldfarb. A recent survey conducted by the National Cancer Institute, however, revealed that a majority of Americans continues to practice poor eating habits, despite evidence that a more healthy diet can reverse the course of many life-threatening illnesses.


"It is our hope that better eating habits and simple, everyday herbs like cinnamon can become allies in people's journey toward disease-free living through proper nutrition," says Dr. Goldfarb. So, while a spoonful of sugar helps the medicine go down, a spoonful of cinnamon offers much, much more.


cinnergen

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People who drink moderate amounts of alcohol and are physically active have a lower risk of death from heart disease and other causes than people who don't drink at all, according to new research. People who neither drink alcohol nor exercise have a 30-49 per cent higher risk of heart disease than those who either drink, exercise or both.


The research, which was published in the European Heart Journal [1] today (Wednesday 9 January), is the first to look at the combined influence of leisure-time physical activity and weekly alcohol intake on the risk of fatal ischaemic heart disease (a form of heart disease characterised by a reduced blood supply to the heart) and deaths from all causes.


Between 1981-1983 Danish researchers obtained information on various health-related issues (including exercise and alcohol intake) from 11,914 Danish men and women aged 20 or older, who were taking part in the larger, Copenhagen City Heart Study.


During approximately 20 years of follow-up there were 1,242 cases of fatal ischaemic heart disease (IHD) and 5,901 deaths from all causes among the study participants.


Professor Morten Gr??nb?¦k, Director of Research of the National Institute of Public Health at the University of Southern Denmark in Copenhagen, and Professor Berit Heitmann, Director for Research of the Institute of Preventive Medicine at Copenhagen University Hospitals, supervised the research. Prof Gr??nb?¦k said: "Our study shows that being both physically active and drinking a moderate amount of alcohol is important for lowering the risk of both fatal IHD and death from all causes. For both men and women, being physically active was associated with a significantly lower risk for both fatal IHD and all-cause mortality than being physically inactive; and drinking alcohol was associated with a lower risk of fatal IHD than abstaining. A weekly moderate alcohol intake reduced the risk of all-cause mortality among both men and women, whereas the risk among heavy drinkers was similar to non-drinkers."


The lead author of the study, Jane ??stergaard Pedersen, a research assistant at the National Institute of Public Health, said: "An important finding from our research for people who have reasons for alcohol abstention such as religious beliefs, previous alcoholism or pregnancy, is that physical activity can reverse some of the adverse health effects associated with alcohol abstention. People who did not drink but whose physical activity was moderate or high, had a lower risk of IHD than the inactive non-drinkers."


Physical activity was divided into three categories:


1. Physically inactive (less than two hours of light physical activity a week such as reading, watching television, going to the cinema);


2. Low level of activity - light physical activity for two to four hours a week (walking, cycling, light gardening, light physical exercise);















3. Moderate to high level of physical activity - light physical activity for more than four hours a week or more vigorous activity for two to four hours a week (brisk walking, fast cycling, heavy gardening, sports that cause perspiration or exhaustion), or vigorous physical activity for more than four hours a week, regular heavy exercise, or competitive sports several times a week.


Alcohol intake was classified according to people's reported total weekly intake, with one drink corresponding to one bottle of beer, one glass of wine and one unit of spirits. Non-drinkers consumed less than one drink a week, moderate drinkers had between 1-14 drinks a week, and heavy drinkers drank 15 or more a week.


Within each level of physical activity, non-drinkers had a 30-31 per cent higher risk of IHD compared to moderate drinkers. However, non-drinkers who had a moderate or high level of physical activity had a reduced risk of IHD of 31 and 33 per cent respectively compared to physically inactive non-drinkers. People who drank at least one drink a week and were physically active had a 44-50 per cent lower risk of IHD compared to physically inactive non-drinkers.


When looking at deaths from all causes (including IHD) the researchers found that within each category of weekly alcohol intake, the physically inactive had the highest risk of death and within each level of physical activity the moderate drinkers had the lowest risk of death from all causes. Compared with physically inactive non-drinkers, being physically active was associated with a 23 per lower risk of deaths from all causes, and being physically active and drinking at least one drink a week was associated with 12-33 per cent lower risk of death.


Ms ??stergaard Pedersen said: "The lowest risk of death from all causes was observed among the physically active moderate drinkers and the highest risk among the physically inactive non- and heavy drinkers."


She concluded: "Neither physical activity alone nor alcohol intake can completely reverse the increased risk associated with alcohol abstention and lack of physical activity. Thus, both moderate to high levels of physical activity and a moderate alcohol intake are important for lowering the risk of fatal IHD and deaths from all causes."


Notes:


[1] The combined influence of leisure-time physical activity and weekly alcohol intake on fatal ischaemic heart disease and all-cause mortality. European Heart Journal, doi:10.1093/eurheartj/ehm574


A PDF of the full report is available on request from Emma Mason or is available from 10.00 hrs London time on Monday, 7 January, here.


The European Heart Journal is the flagship journal of the European Society of Cardiology. Please acknowledge the journal as a source in any articles.

European Society of Cardiology

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Type 2 diabetics
treated with low-dose aspirin did not have a significantly lower incidence
of atherosclerotic events than those who received placebo in this primary
prevention trial of low-dose aspirin, according to research presented at
the American Heart Association's Scientific Sessions 2008. However,
sub-group analyses showed a significant reduction with aspirin in both
atherosclerotic events in those over 65 years of age, and a reduction in
cerebrocardiovascular deaths. Results from The Japanese Primary Prevention
of Atherosclerosis with Aspirin for Diabetes (JPAD) trial were presented as
a late-breaking clinical trial. The study was simultaneously published in
the Journal of the American Medical Association.



"Our results indicate that aspirin is effective and safe for primary
prevention of cardiac and cerebrocardiovascular death in diabetics," said
Hisao Ogawa, M.D, Ph.D., lead investigator of the study and a professor of
cardiovascular medicine at Kumamoto University, Kumamoto, Japan, and chief
of the division of cardiology at the Kumamoto University Hospital. "In
addition, it offers a low-cost approach."



The randomized trial included 2,539 type 2 diabetics at 163 Japanese
medical centers.



Researchers observed a positive trend for a reduction in all
atherosclerotic events in the aspirin group (20 percent relative risk
reduction) for the entire population, but it did not reach statistical
significance. Atherosclerotic events include coronary heart disease death,
fatal stroke, non-fatal myocardial infarction, unstable angina, exertional
angina, non-fatal stroke including transient ischemic attack, and
peripheral arterial disease.



In a subgroup analysis, the researchers found an association between
daily low-dose aspirin use and a 32 percent reduced relative risk for all
atherosclerotic events, both fatal and non-fatal, but only for diabetics
over age 65. In other words, individuals over age 65 who took aspirin had a
hazard ratio of 0.68 compared to those who did not take aspirin.



During an average of 4.4 years of follow-up, 154 atherosclerotic events
occurred, both fatal and non-fatal (68 in the aspirin group, 86 in the
non-aspirin group.) Those events included one fatal cardiovascular event (a
hemorrhagic stroke) in the aspirin group and 10 fatal strokes or heart
attacks in the non-aspirin group, Ogawa said.
















Researchers found a large, statistically significant risk reduction for
fatal coronary and cerebrovascular events in the aspirin group vs. the
non-aspirin group (hazard ratio of 0.10.) But the confidence interval on
that finding was wide (CI=0.01 to 0.8), indicating a need for further
study, he said.



Diabetes is considered one of the strongest risk factors for
cardiovascular events. Aspirin therapy is commonly used for primary
prevention in diabetic patients in the United States and Canada, but not in
Japan, Ogawa said.



Several earlier studies have established the benefits of aspirin
therapy in preventing second cardiac events. However, its use for primary
prevention in diabetics, i.e., prevention in patients without a history of
cardiovascular disease, has been controversial because of the lack of data
indicating benefits and because aspirin carries a risk of gastric bleeding,
Ogawa said.



He said aspirin was well tolerated as demonstrated by the comparable
number of the combined endpoint of serious hemorrhagic events (hemorrhagic
strokes and major gastrointestinal bleeds).



In comparing bleeding events, the researchers reported 13 hemorrhagic
strokes, with no statistically significant difference between aspirin
takers and non-takers (six such strokes in the aspirin group; seven in the
non-aspirin group).



On the other hand, the total number of all hemorrhagic events was
greater in the aspirin group compared to the non-aspirin group (34 vs. 10
such events). Four patients in the aspirin group had bleeding events that
required transfusion. Furthermore, those in the aspirin group had more
gastrointestinal symptoms (55 cases vs. eight cases), but all cases were
resolved without surgery and no fatalities occurred, he said.



"Our findings need to be interpreted in the context of the low
incidence of atherosclerotic disease in Japan," Ogawa said. "We conclude
that aspirin as primary prevention is beneficial at least for fatal heart
attack and fatal stroke in our entire study group and for all
atherosclerotic disease among those age 65 or over."



Co-authors are: Masafumi Nakayama, M.D., Ph.D.; Takeshi Morimoto, M.D.,
Ph.D.; Shiro Uemura, M.D., Ph.D.; Masao Kanauchi, M.D., Ph.D.; Naofumi Doi,
M.D., Ph.D.; Seigo Sugiyama, M.D., Ph.D.; and Yoshihiko Saito, M.D., Ph.D.
Individual author disclosures are available on the abstract.



The study was funded by Japan's Ministry of Health, Labour and Welfare.



Statements and conclusions of study authors that are presented at
American Heart Association scientific meetings are solely those of the
study authors and do not necessarily reflect association policy or
position. The association makes no representation or warranty as to their
accuracy or reliability. The association receives funding primarily from
individuals; foundations and corporations (including pharmaceutical, device
manufacturers and other companies) also make donations and fund specific
association programs and events. The association has strict policies to
prevent these relationships from influencing science content. Revenues from
pharmaceutical and device corporations are available at
americanheart/corporatefunding.


American Heart Association

americanheart

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Treatments modelled on the cancer drug Gleevec could potentially prevent the formation of amyloid plaques - one of the major hallmarks of Alzheimer's disease according to a study.


Treatments modelled on the cancer drug Gleevec could potentially prevent the formation of amyloid plaques - one of the major hallmarks of Alzheimer's disease according to a study published in the journal Nature.


Researchers at the Laboratory of Molecular and Cellular Neuroscience in the U.S. tested the drug on mice and found that Gleevec has the ability to attach itself to a protein (GSAP). GSAP promotes the production of plaques in the brain and is therefore a potential target for anti-amyloid treatments.


Alzheimer's Society comment:


'This study provides us with exciting new information about a protein that has been found to promote the production of amyloid plaques - a major hallmark of Alzheimer's disease. Although the drug highlighted in the report targets this protein and is available and safety tested, this research is in the early stages and we are some way from this being a viable treatment for Alzheimer's.


'A million people will develop dementia in the next ten years yet dementia research receives eight times less investment than cancer research. We must invest now if we are to move forward in the development of effective Alzheimer's treatments.'


Dr Susanne Sorensen

Head of Research


Ref: Gen He et al., 'Gamma-secretase activating protein is a therapeutic target for Alzheimer's disease', Nature, 2 September 2010

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RockHard Laboratories has announced that it is conducting a voluntary nationwide recall of the company's dietary supplements sold under the brand names RockHard Weekend and Pandora specific to the following Lot Numbers:



RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3ct bottles and 8ct bottles.

Pandora Lot Numbers: 100378 sold as blister packs.


RockHard Laboratories is conducting a voluntary recall after its independent testing found the RockHard Weekend and Pandora products, specific to the above lot numbers, contain an analogue of Sildenafil. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.



Use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.



RockHard Laboratories advises any customers in possession of the RockHard Weekend and/or Pandora products matching the lot numbers above to return any unused product for a full refund to the company directly. Customers can call 1.877.576.9363 for instructions on the return and refund process.



RockHard Laboratories is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. RockHard Laboratories promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.



Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Online: fda/MedWatch/report.htm


Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: fda/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178


This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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The investigational chemotherapeutic agent eribulin mesylate (E7389) demonstrated activity in a heavily pretreated population of women with locally advanced or metastatic breast cancer, according to results of a multi-center Phase II clinical trial. The study also suggests that eribulin mesylate has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling or life-threatening) neuropathy. These data (abstract #1084) will be presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) on Monday, June 2 from 2 to 6 p.m. at S Hall A1 of McCormick Place.



"The anti-tumor activity of eribulin mesylate, as observed in this study, is encouraging, given the limited treatment options for women with advanced breast cancer who have previously received multiple lines of therapy," said lead investigator Linda T. Vahdat, MD, of Weill Cornell Medical College in New York. ??"The subjects in this trial had received a median of four prior chemotherapy regimens that included an anthracycline, a taxane and capecitabine."



About Study 211 Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of eribulin mesylate in patients with locally advanced or metastatic breast cancer who had received an anthracycline, a taxane and capecitabine as prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy.



Of 299 patients enrolled in the study, 291 were treated with eribulin mesylate. The median age of those patients was 56 years (range: 26-80 years). Eribulin mesylate was administered at a dose of 1.4mg/m2 as a 2- to 5-minute intravenous infusion on Days 1 and 8 of a 21-day cycle. Patients received a median of four cycles of eribulin mesylate (range 1-27). No premedication to prevent hypersensitivity was required.



Two-hundred sixty-nine patients met the key inclusion criteria. In patients who received a median of four cycles of eribulin mesylate, Overall Response Rate (ORR) by Independent Review (IR) was 9.3% (all Partial Responses (PR); 95% confidence interval [CI]: 6.1%-13.4%). Investigator-assessed ORR was 14.1% (1 CR; 95% CI: 10.2%-18.9%). Nearly half (46.5%) the patients had stable disease (SD) after treatment with eribulin mesylate. The clinical benefit rate (CBR, defined as CR+PR+SD ????6 months) was 17.1% (95% CI: 12.8%-22.1%).



The median duration of response was 4.2 months (126 days, range: 42 -258 days; 95% CI: 86-147). Median progression-free survival (PFS) was 2.6 months (79 days, range: 1*-397 days), and the median overall survival (OS) rate was 10.3 months (315 days, range: 19-604 days; 95% CI: 279-350). The six-month PFS and OS rates were 16.0% (95% CI: 8.6-17.0) and 72.3%, respectively (95% CI: 66.9-77.6).
















The safety analysis included all 291 patients who received treatment with eribulin mesylate. Patients with up to Grade 2 peripheral neuropathy were included in the study. The most frequently reported Grade 3 (severe) or Grade 4 (disabling or life- threatening) adverse events were neutropenia (a decrease in the number of granular white blood cells, 54%); febrile neutropenia, 5.5%, leukopenia (low white blood cell count, 14%), and weakness/fatigue (10%; no Grade 4 events). Grade 3 peripheral neuropathy (a functional disturbance or damage to nerves outside the brain and spinal cord) was reported in 5.5% of patients. No Grade 4 peripheral neuropathy events were reported. No correlation was seen between Grade 2 peripheral neuropathy and deterioration.



"In this study, eribulin mesylate appeared to have an acceptable tolerability profile, particularly with regard to the low incidence of peripheral neuropathy," noted Vahdat. "None of the reported cases of neuropathy were disabling, suggesting that eribulin mesylate, if approved, may be a useful addition to the treatment armamentarium for advanced breast cancer."







About Eribulin Mesylate



Eribulin mesylate is being developed by Eisai as a potential new chemotherapeutic agent. It suppresses the growth of microtubules, which are involved in various cellular processes in the body, such as cell division. Eribulin mesylate is a synthetic analog of halichondrin B, a naturally occurring compound which was first isolated from a marine sponge Halichondria okadai in 1992.



About Eisai Corporation of North America



Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.



Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.

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