Despite decades of advances in diabetes care, African Americans and Latinos are still far less likely than whites to have their blood sugar under control, even with the help of medications, a new nationally representative study finds. That puts them at a much higher risk of blindness, heart attack, kidney failure, foot amputation and other long term diabetes complications.

The comprehensive new national study of middle-aged and older adults, published in the Sept. 24 issue of the Archives of Internal Medicine, was performed by a team from the University of Michigan and the VA Ann Arbor Healthcare System.

The study documents the persistence of strong racial and ethnic disparities in diabetes control, which have been observed for decades and contribute to the much greater impact of diabetes on those two ethnic groups. The results suggest that diabetes will continue to kill and disable black and Latino adults disproportionately for decades to come.

But the study delves deeper into the reasons behind this difference in blood sugar levels, using complex statistical analysis to find factors that do — and don’t — play a role. For instance, diabetes control was worse among black and Latinos under age 65.

Most notably, two factors were found to account for a sizable portion of the racial and ethnic difference in glucose control: how well patients persist in taking their diabetes medicines regularly, and how they respond emotionally to having diabetes. Fortunately, these factors are likely to change in response to specific outreach efforts including some now underway by the U-M researchers. The study also hints that more factors are at work.

“While we were taken aback to see that diabetes control still varies so much by race and ethnicity, we’re encouraged that two of the crucial factors are modifiable,” says Michele Heisler, M.D., MPA, an assistant professor of Internal Medicine at the U-M Medical School and a research scientist at the VA Ann Arbor’s Center for Clinical Practice Management Research. “To improve diabetes outcomes, we must do better at supporting all patients in managing their disease through treatment and lifestyle change. But we need to tailor specific interventions to address the barriers to achieving good diabetes control that African American and Latino adults with diabetes disproportionately face.”

The study is based on very recent data from the Health and Retirement Study, a decades-long national effort to assess the health of adults over age 50 through regular completion of intensive questionnaires and health examinations.

Funded by the National Institute on Aging, and based at the U-M Institute for Social Research, the HRS began assessing the blood sugar levels of participants in 2003. In the older age groups where Type II diabetes is mostly found, the new study is larger than the other major source of population-wide data on this issue, the National Health and Nutrition Examination Survey (NHANES) run by the Centers for Disease Control and Prevention.

In all, 1,199 people over age 55 with diabetes were included in the new study. Their blood sugar was measured using the A1C test, which gives an average blood glucose level over the last three months and is considered a more accurate gauge of glycemic control than a simple glucose test.

“The ability to obtain such an important clinical marker on a large national sample is a major step forward in using population surveys to understand health disparities in the older population,” said David Weir, Ph.D., director of the Health and Retirement Study and a research professor at ISR.

Current guidelines call for people with diabetes to maintain an A1C level of under 7 percentage points, to slow the rate of damage to nerves, blood vessels and organs that can lead to deadly and debilitating diabetes complications. People without diabetes typically have an A1C under 6 points.

But when the researchers analyzed data from study participants who were taking medications to control their blood sugar, the difference between the mean A1C for whites and the means for the other ethnic groups was large. White people had a mean A1C of 7.22 points, while the levels for blacks and Latinos were 8.07 and 8.14, respectively. People with diabetes are typically prescribed medications for glucose control only when diet and exercise no longer keep their levels in check.

An even bigger difference was seen when the researchers looked at the 286 participants on medications who were between ages 55 and 64 too young for Medicare coverage. Whites had an average A1C of 7.46, but blacks were at 8.96 and Latinos were at 8.91. By contrast, there was a much smaller difference in average A1C among members of the three groups over age 65.

The researchers then performed a statistical analysis that took into account all of the available information about all the participants who were taking medication everything from their education level and annual household income to their mental health, insurance coverage status, quality of health care, medication regimens, exercise, diet, as well as their attitudes and behaviors about taking medications, monitoring blood sugar levels, and other key diabetes self-care tasks. The data also included participants’ answers to a questionnaire that assesses a person’s emotional response to living with diabetes, and a questionnaire about how they were managing their disease including how well they adhered to the diabetes medications prescribed by their doctors.

A multvariate statistical analysis then allowed the researchers to separate out factors associated with higher A1C levels, and to assess how those factors in turn were associated with ethnicity. It also allowed them to adjust for differences in income, education, and all the other factors.

In the end, the factors that showed the strongest influence on racial and ethnic differences in A1C levels were medication adherence (especially among African Americans) and emotional distress related to diabetes (especially among Latinos). African Americans reported more barriers to taking their medications, and less adherence to their medication, than the other groups. Meanwhile, Latinos reported much higher levels of distress related to their diabetes than other groups.

Even so, all the factors examined in the analyses that might account for the observed racial and ethnic disparities in glycemic control accounted for only 14 percent of the African American-white disparity, and 19 percent of the Latino-white disparity, in blood sugar control. Meanwhile, differences in income and education level two factors long hypothesized to be key determinants of worse diabetes outcomes did not explain the glucose control differences, once the other factors were included in the analyses.

The authors conclude that additional factors not assessed in the study, such as genetics, stress levels and other environmental factors, intensity of medication regimens, and the generosity of patients’ prescription drug insurance coverage must account for a large part of the picture.

“Medication adherence was one of the strongest predictors of glucose control across the board,” says Heisler. “This reinforces that by targeting barriers to medication adherence such as patient-doctor communication about medications, patient trust in health systems, patient confidence that medication actually helps, cost barriers, and other barriers that African Americans disproportionately face we can make a difference.”

“Diabetes is one of the most important health challenges faced by Americans and American society today,” notes Richard Suzman, Ph.D., director of behavioral and social research at the National Institute on Aging. “These results illuminate some of the behavioral and other issues associated with glycemic control that can be useful in designing strategies and interventions to reach diverse populations.”

Heisler and her colleagues are currently conducting two randomized controlled trials of such interventions in people with diabetes who have high A1C levels, blood pressures, and lipid (cholesterol) levels. One, supported by the National Institutes of Health and the VA, includes nurse-led group sessions where patients can break their longer-term diabetes self-care goals into short-term specific steps, and chance for patients to link up with a diabetes peer “buddy” who faces similar self-care challenges, to provide mutual coaching and support during weekly telephone calls.

The other, funded by the National Institute for Diabetes and Digestive and Kidney Diseases and VA, is training VA pharmacists to reach out to diabetes patients with poor risk factor control and pharmacy data that shows difficulties refilling medications. The clinical pharmacists will provide “motivational-interviewing-based” adherence assessment and counseling. This proactive outreach will specifically target blood pressure, which like glucose is a crucial factor in the development and progression of diabetes complications. The pharmacists will also have the ability to increase patients’ dosages of blood pressure medications, within a framework pre-approved by physicians.

In addition to Heisler and Weir, the newly published study is co-authored by U-M and VA researchers Jessica Faul, MPH, Rodney Hayward, M.D., Kenneth Langa, M.D., Ph.D., and Caroline Blaum, M.D. It was supported by NIA, VA, and the Michigan Diabetes Research and Training Center. Reference: Archives of Internal Medicine, Vol. 167 No. 17, Sept. 24, 2007.

University of Michigan Health System
2901 Hubbard St., Ste. 2400
Ann Arbor, MI 48109-2435
United States
med.umich Continue reading →

Manhattan Pharmaceuticals, Inc. (Amex: MHA) today reported receipt of Swiss regulatory approval to commence its Phase IIa study with oral Oleoyl-estrone (OE), the company’s drug candidate for the treatment of obesity.

The single center, Phase IIa study is a randomized, double-blind,
placebo-controlled, parallel group study designed to evaluate the safety,
preliminary efficacy, and pharmacokinetics of two 14-day dosing cycles in
obese adult subjects. 100 subjects will be randomly enrolled in one of four
treatment groups. Dose levels of OE will be placebo, 5, 10, or 20 mg taken once daily. Each 14-day dosing cycle will be followed by a 28-day treatment free evaluation period.

“This approval marks a significant achievement in the clinical
development program with oral Oleoyl-estrone,” said Douglas Abel,
Manhattan’s CEO. “Given the encouraging early trial results and the large
unmet medical need in obesity, we are very pleased to be able to proceed
toward patient recruitment and enrollment.”

“Oleoyl-estrone is a promising drug candidate and is thought to work
both centrally and peripherally,” said Alan G. Harris, MD, PhD, Manhattan’s chief medical officer. “Centrally, it appears to reset the body’s ponderostat, the ‘food control center’ located in the hypothalamus of the brain that detects and integrates signals controlling appetite and
metabolic behavior. Peripherally, OE appears to cause reduced storage of fat in ‘white fat’ tissue and allows skeletal muscle to use fat as an
alternate energy source.”

OE is an orally administered, synthetic form of Oleoyl-estrone, a
molecule that exists naturally in the body. Results of the Phase I clinical
trials with OE, reported in October 2005, showed the compound was well
tolerated. Subjects in the Phase Ib study experienced weight loss as well
as beneficial changes in blood glucose and cholesterol levels. There was
also evidence of OE offering the potential for sustained weight loss after
dosing with OE stopped. Clinical laboratory findings included reversible,
dose-dependent elevations in estrone and estradiol levels, as well as
reductions in testosterone levels.

Obesity is rapidly becoming a global epidemic. The US Centers for
Disease Control reports that 65 percent of Americans are overweight and 30 percent are obese. The number of clinically obese Americans is expected to grow from 73 million to 94 million during the next 5-6 years.

Currently marketed obesity treatments have not been shown to be
particularly effective in accomplishing sustained weight loss. Even if
weight loss is achieved, current obesity treatments do not reduce the
likelihood of regain of lost weight once treatment has stopped. Most
marketed weight loss therapeutics also cause unwanted side effects.

About Manhattan Pharmaceuticals, Inc.

Manhattan Pharmaceuticals, Inc., a development-stage pharmaceutical
company, acquires and develops proprietary prescription drugs for large,
underserved patient populations. In view of the worldwide obesity epidemic, the company is developing OE, an orally administered novel therapeutic for the treatment of obesity. To meet the needs of other major, underserved medical markets while lowering development risks, Manhattan Pharmaceuticals is also developing PTH (1-34), a peptide believed to be a regulator of epidermal cell growth, for psoriasis, and Propofol Lingual Spray, a convenient, proprietary lingual spray formulation of propofol, the world’s best-selling general anesthetic, as a sedative-hypnotic for use during diagnostic and therapeutic procedures. (manhattanpharma)

Note Regarding Forward-Looking Statements

This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
statements are valid only as of today, and we disclaim any obligation to
update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion and results of clinical trials, including clinical trials involving oleoyl-estrone, the FDA review process and other governmental regulation, our pharmaceutical collaborator’s ability to successfully develop and commercialize drug candidates, issues relating to drug formulation and manufacturing, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors described in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-KSB for the year ended December 31, 2005. The Company assumes no obligation to update these statements, except as required by law.

Manhattan Pharmaceuticals, Inc.
manhattanpharma

View drug information on Estradiol Transdermal System. Continue reading →

Administering Human Papillomavirus Vaccine (HPV) to both sexually active women and those who have never had sex could substantially reduce the incidence of HPV related cervical cancer and precancers, conclude authors of an Article published in this week’s edition of the Lancet.

Cervical cancer is the second leading cause of death from cancer in women worldwide, and is caused by infection with oncogenic (cancer causing) types of human papillomavirus. Around 500,000 new cases are diagnosed each year, 80% in developing countries, resulting in 250,000 deaths.

Dr Kevin Ault, Emory University School of Medicine, Atlanta, Georgia, USA and colleagues from around the world formed the Future II Study Group to investigate the efficacy of the vaccine.

For women who have never had sex, the vaccine was 99% effective in stopping cervical cancer (adenocarcinoma in situ), and pre-cancerous lesions.

When data from women who could have been exposed was included, the vaccine efficacy was 44%.

The researchers enrolled over 20,000 women aged 15-26 from the Americas, Europe and Asia-Pacific in the study. Some 9,000 of these were given the full vaccine; around 1,200 were given a component of the vaccine and the rest a placebo.

The women involved were recruited at university student health centres, urban clinics, advertisements and by word of mouth. Healthy women who were not pregnant, had no report of a previous abnormal pap smear, and had a lifetime history of less than four to five sex partners were eligible.

The authors say that further follow-up of large trials will be needed to establish how long the vaccine remains effective.

They conclude: “The results of this quadrivalent HPV vaccine programme provide strong evidence that implementation of HPV vaccination campaigns in pre-adolescent girls and young adult women will reduce rates of cervical cancer worldwide.”

In an accompanying comment, Dr Maurie Markman, University of Texas M.D. Anderson Cancer Centre, Houston, Texas, USA, says a number of questions remain around HPV vaccination, including how long the vaccine will work, the best age at which to administer it, its cost and whether men and boys should also be vaccinated.

He concludes: “Other important hurdles need to be overcome, including: the absence of health-delivery infrastructure in many countries to permit comprehensive vaccination programmes, the politically-charged debate surrounding the issue of voluntary versus mandatory vaccination, the existence of unsubstantiated claims that HPV vaccination will encourage promiscuity, and the belief by some that vaccination is unnecessary in the developed world due to the effectiveness of cervical cancer screening strategies.”

Contact: Juliette Merchant

Lancet Continue reading →

Euthymics Bioscience, Inc. announced the initiation of an advanced clinical study of its lead product candidate EB-1010 for the treatment of major depressive disorder (MDD). The TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects) trial is a phase 2b/3a clinical trial designed to assess the safety and efficacy of EB-1010, a novel serotonin-preferring triple reuptake inhibitor. The trial will be conducted at 25 centers throughout the U.S., and Euthymics plans to enroll approximately 300 individuals. Patient recruitment is now underway and top-line results are expected in mid-2012.

Euthymics’ EB-1010 acts on three neurotransmitters-serotonin, norepinephrine and dopamine-in a ratio of 1 to 2 to 8. EB-1010 is intended for patients with major depressive disorder who do not respond adequately to a single course of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), the most common medications in the $20 billion global antidepressant market. However, a large subset of patients with major depressive disorder, about 66%, do not experience remission after initial treatment with SSRIs, according to the STAR*D study, a large seven-year study sponsored by the National Institute of Mental Health. Even substituting an SNRI did not improve outcomes. However, STAR*D also showed that outcomes improved when patients were treated with multiple medications to modulate serotonin, norepinephrine and dopamine. EB-1010 recapitulates this triple profile in a single molecule.

“There is great need for an effective medication with a favorable side effect profile for the millions of patients who do not respond fully to or are not compliant with current antidepressant treatments, such as SSRIs or SNRIs,” said the principal investigator of the TRIADE study Maurizio Fava, M.D., Professor of Psychiatry at Harvard Medical School and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital. “It is exciting to be involved in the study of this novel serotonin-preferring triple reuptake inhibitor.”

The TRIADE trial (also known under the protocol number EB-1010-301) is a phase 2b/3a trial testing both the efficacy and safety of EB-1010 and comparing to it to placebo and a standard treatment. TRIADE is a 12-week double-blind, placebo-controlled trial intended to measure changes in the Montgomery-?…sberg Depression Rating Scale (MADRS), a standard measure of depression. Secondary measures include sexual function, weight gain and cognition. The trial will use an advanced study design called Sequential Parallel Comparison Design (SPCD), a clinical trial methodology co-invented by Dr. Fava, to increase efficiency and reduce confounding placebo responses, a major issue in clinical trials for depression. The trial will have four arms: two doses of EB-1010 (standard dose 100 mg and half dose 50 mg), a placebo arm, and-under SPCD protocol-there will be an active comparator arm with subjects receiving paroxetine (Paxil®).

Results of a previous phase 2 trial presented at the 2010 annual meeting of the American College of Neuropsychopharmacology (ACNP) showed that EB-1010 was effective in treating MDD based on multiple standard measures of outcome. The trial also showed that EB-1010 improved measures of anhedonia and was well tolerated, without the weight gain or sexual dysfunction associated with the most common pharmacological treatments for depression.

Anthony A. McKinney, President and CEO of Euthymics, said, “The promising results we reported previously at ACNP provided important validation for the potential of EB-1010′s unique profile to treat a large segment of the patient population with major depression. We believe EB-1010 has the potential to become the first triple reuptake inhibitor to achieve the efficacy of multiple neurotransmitter reuptake inhibitors in a single medication, and we are eager to further evaluate its potential with the TRIADE clinical trial.”

As a serotonin-preferring triple reuptake inhibitor, EB-1010 demonstrates greatest affinity for the transporters for serotonin reuptake; it is half as potent for norepinephrine and has one-eighth the potency for dopamine, resulting in a ratio of 1:2:8. This is in contrast to balanced triple reuptake inhibitors which have equal affinity for the three monoamines, and have not demonstrated efficacy in depression. EB-1010 is delivered as monotherapy without the cost or complexity of multiple prescriptions.

Continue reading →

Sunesis
Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced that the company will
present data from clinical and preclinical studies of SNS-595 in advanced
leukemias at the upcoming American Society for Hematology (ASH) Annual
Meeting being held December 9-12, 2006 in Orlando, FL. SNS-595 is a
first-in-class cell-cycle modulator that is believed to act by targeting
proliferating cancer cells and inducing apoptosis, or programmed cell
death, during the S phase of the cell cycle.

Sunesis is conducting a Phase 1 clinical trial to examine the safety,
tolerability and pharmacokinetics of SNS-595 among patients with refractory
acute leukemia (primarily AML). Preliminary results from the Phase 1
clinical trial and from preclinical studies of SNS-595 will be presented in
two poster sessions on Sunday, December 10, 2006 starting at 9:00 a.m.
Eastern Time in Hall E1 of the West Building at the Orange County
Convention Center.

Session: Acute Myeloid Leukemia: Novel Therapies

A Phase 1 Dose-Escalation Study of the Novel Cell Cycle Active Agen SNS-595 in Advanced Leukemias

Session: Leukemias: Biology, Cytogenetics, and Molecular Markers in
Diagnosis and Prognosis: AML

SNS-595 a Novel S Phase Active Cytotoxic Acts Synergistically with Cytarabine To Reduce Bone Marrow Cellularity and Circulating Neutrophils

About Sunesis’ Oncology Programs

Sunesis has built a portfolio of preclinical- and development-stage
product candidates in oncology focused on novel pathways and targets,
including inhibition of the cell-cycle and survival signaling. Sunesis is
currently conducting Phase 2 and Phase 1 clinical trials in lung cancer and
acute myeloid leukemia for its lead compound, SNS-595. A second compound,
SNS-032, is in a Phase 1/2 clinical trial to examine the safety and
preliminary anti-tumor activity among patients with lung cancer, breast
cancer or melanoma. Sunesis is also conducting GLP toxicology studies of a
third drug candidate, an Aurora kinase inhibitor known as SNS-314. In
addition, in cooperation with Biogen Idec, Sunesis is developing novel
small molecule inhibitors of Raf kinase and other oncology kinases.

About Sunesis Pharmaceuticals

Sunesis is a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of novel small molecule
therapeutics for oncology and other serious diseases. Sunesis has built a
broad product candidate portfolio through internal discovery and
in-licensing of novel cancer therapeutics. Sunesis is advancing its product
candidates through in-house research and development efforts and strategic
collaborations with leading pharmaceutical and biopharmaceutical companies.
For additional information on Sunesis Pharmaceuticals, please visit
sunesis.

Forward-Looking Statements

This press release may contain forward-looking statements that involve
substantial risks and uncertainties. Sunesis may not actually achieve the
plans, intentions or expectations contained in such forward-looking
statements. Actual results or events could differ materially from the
plans, intentions and expectations contained in such forward-looking
statements. Sunesis does not assume any obligation to update any such
forward-looking statements. For further information on Sunesis
Pharmaceuticals, please visit sunesis.

Sunesis Pharmaceuticals, Inc.
sunesis Continue reading →

Sciona, Inc., a leader in the
science of nutrigenetics, announced the results of a pivotal study
published by Nutrition Journal, which demonstrates substantial advances in
long term weight management and blood glucose levels as a result of
personalizing patients’ diets based on their genetic information
(nutrigenetics). In the first study to demonstrate the efficacy of applying
nutrigenetics to long term weight management, researchers found significant
improvement in long term (more than 300 days) weight management for
individuals whose nutrient requirements were tailored to individual
variations in the genes known to affect nutrient metabolism and transport.
Each subject’s genetic profile was developed by the use of Sciona’s Mycellf
Kit.

The comprehensive 3 year study examined 93 individuals with a history
of weight loss failures. In an effort to answer whether the application of
genetic information could improve sustained weight management, one test
group was genetically screened for (24) separate variants in (19)
individual genes specifically know to be related to metabolism. A second
control group did not receive the genetic screening. The groups were
matched on characteristics such as age, gender, frequency of clinical
visits and Body Mass Index (BMI), during their initial clinical visit.
After monitoring patients between the fixed ranges of 100 – 300 days, the
BMI and the fasting blood glucose levels were compared and contrasted
within the test population.

Results conclusively showed that after 300 days, individuals in the
genetic testing group were more likely to have maintained weight reduction
and reduced glucose levels than those of the control group, which had not
been genetically screened. In the final analysis, 73% of those in the
nutrigenetic group maintained weight reduction compared to only 32% of
those in the control group. Among patients with a fasting blood glucose of
greater than 100 mg/dl, 57% of the nutrigenetic group, compared to only 25%
of the control group had levels reduced to less that 100 mg/dl after more
than 90 days of weight management therapy. These results reflected a return
to normal blood glucose levels from pre-diabetic levels in the nutrigenetic
group, based on a genetically tailored diet and exercise program.

Sciona’s Chief Science Officer, Dr. Rosalynn Gill stated, “We are
delighted with the results of this study given the global health problems
associated with clinical obesity and diabetes.” Dr. Gill went on to note
that according to the US Department of Health and Human Services, the total
cost of obesity, including those illnesses associated with obesity such as
type II diabetes, coronary heart disease, and hypertension in the year 2000
was approximately $117 billion dollars. Sciona’s CEO, Peter Vitulli,
stated, “Sciona’s Mycellf genetic testing kit allows an individual to learn
how to personalize their nutrition and lifestyle to match their genes,
which gives them a revolutionary gene-based road map to better health and a
longer life.” Study coordinator, Dr. Ioannis Arkadianos, stated, “The
results of this clinical study featuring the application of nutrigenetics
clearly demonstrates that using genetic information is critical in helping
people optimize their health. As a clinician, it is gratifying to be able
to apply the information regarding an individual’s inherited genetic code
to help us to understand how each person’s body works. We finally have the
tools that enable health care professionals such as myself to determine
which nutrition and exercise protocols will get results and what
nutrigenetic interventions will promote longevity. Just like fingerprints,
no two individuals are the same and so we are now able to personalize your
health based on your DNA.”

Summary: Tailoring a weight loss program to individuals’ unique genetic
profiles, even in a group with a history of prior weight loss failures,
resulted in significant improvements in better compliance, greater
motivation, and improved effectiveness when measured by weight reduction,
BMI, and glucose levels, in a long term study, over 300 days.

About The Study

Patients with a history of unsuccessful attempts at weight loss
attending a weight management clinic in Athens, Greece were offered a
nutrigenetic test screening 24 variations in 19 genes involved in
metabolism. The case histories of 50 “nutrigenetic” patients were compared
to those of 43 patients in the non-tested group attending the same clinic.
All patients followed a traditional weight management program involving a
low glycemic index Mediterranean diet, recommended exercise routines and
regular follow-up visits in the clinic. The dietary program of the patients
in the nutrigenetic group was modified from the standard diet based on the
genetic results of each patient. The patients participating in the study
were blinded to the clinicians. After 300 days, the patients following the
nutrigenetically tailored diet and exercise programs demonstrated better
long-term BMI reduction and improvements in blood fasting glucose. Key
contributors to the study included the Twin Research Unit, King’s College
London, UK and the Biomedical Engineering Laboratory, National Technical
University of Athens, Greece.

About Sciona, Inc.

Sciona, an international company founded in 2000 to provide
personalized health and nutrition recommendations based on an individual’s
diet, lifestyle and unique genetic profile, has created a powerful set of
tools utilizing their proprietary Rules Engine which allows consumers to
harness the scientific information uncovered in the landmark Human Genome
Project. For more information, visit Sciona, Inc. at Sciona,
or the Mycellf product website at Mycellf.

Sciona, Inc.
Sciona Continue reading →

Now that everyone is in New Year’s Resolution mode, one more challenge to staying in control of getting in tip-top shape is the tough economy.

While you can’t control the economy, you can control your risk of developing one of the growing health problems in America… diabetes.

This Video News Release educates viewers on the importance of diabetes awareness and how simple lifestyle changes — combined with regular screening — can help keep you on top of this all-too-common disease.

Viewers will also learn about a free website, MyHealthTestReminder

– that helps remind you to schedule regular screenings. In less than a minute, visitors to the site — which is offered by the College of American Pathologists, can select the day they would like to receive a free reminder to schedule a blood sugar test, as well as other important health screening tests.
See just how simple it is for you to stay in control of your health.
Expert and Patient interviewed:
– Patricia A. Thomas, MD, FCAP, pathologist
– Robin Wilburn, diabetes patient

The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective medical care.

MyHealthTestReminder Continue reading →

GlaxoSmithKline (GSK) today announced results from a U.S. phase III vaccine clinical study presented this week at the Pediatric Academic Societies’ (PAS) Annual Meeting in Toronto, Canada. The study evaluated the immune response and safety profile of the investigational combination DTaP-IPV (diphtheria, tetanus, acellular pertussis – inactivated poliovirus) vaccine in children ages 4 to 6 years-old as compared to separately administered DTaP (INFANRIX®) and IPV (IPOL®) vaccines, when co-administered with measles, mumps and rubella (MMR) vaccine (M-M-RII®) at a separate site. Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines.

The investigational DTaP-IPV vaccine has not been approved for use in the United States.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that children receive booster shots to protect against diphtheria, tetanus and pertussis (DTaP) and polio (IPV) at the 4 to 6 year-old doctor visit. Most states in the U.S. require either a fifth dose of DTaP vaccine and/or a fourth dose of IPV vaccine for kindergarten school entry. Separately administered DTaP and IPV vaccines are currently used to complete these recommended immunizations.

“An increasing number of vaccines are being recommended to prevent childhood diseases, including additional vaccines at the 4 to 6 year-old doctor’s visit,” said Barbara Howe, MD, Vice President, North American Vaccine Development, GlaxoSmithKline. “We are pleased to be developing a new combination vaccine that if approved, could offer one potential solution to the problem of increased number of injections during single doctor visits.”

DTaP-IPV Study Results

Study participants were distributed into two groups. The combination group (N=3,156 consisting of three groups who received three different lots of DTaP-IPV pooled together) was made up of those children who received the DTaP-IPV plus MMR vaccines. The component group (N=1,053) was made up of those infants who received separately administered DTaP and IPV vaccines plus MMR vaccine. A subset of the children (N=1,331) had serological testing to evaluate the immunogenicity of DTaP-IPV vaccine.

Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines. More specifically:

– Booster response was seen in at least 92.2 percent and 92.6 percent of children in the DTaP-IPV and INFANRIX plus IPOL groups, respectively, for each DTaP antigen.

– All subjects in both treatment groups had seroprotective levels of anti-D, anti-T, and anti-poliovirus types 2 and 3 antibodies; all but 1 subject (in the DTaP-IPV group) had seroprotective anti-poliovirus type 1 levels. At least 99.8 percent of subjects in both groups were seropositive for antibodies to pertussis agents.

– All pre-specified immunogenicity and safety non-inferiority criteria were achieved.

– Overall reported adverse events including swelling at the DTaP-based injection site were comparable in both study groups.

The most commonly reported solicited adverse event (AE) was pain at the DTaP-based injection site: reported by 57 percent of the children who received the investigational DTaP-IPV vaccine and 53 percent of the children who received the separately administered DTaP vaccine. This difference was statistically significant. Redness at the DTaP-based injection site was reported by 37 percent of the children who received the investigational DTaP-IPV vaccine and 37 percent of the children who received the separately administered DTaP vaccine; and swelling at the DTaP-based injection site was reported by 26 percent of the children who received the investigational DTaP-IPV vaccine and 27 percent of the children who received the separately administered DTaP vaccine.

The most commonly reported solicited general AE was drowsiness reported by 19 percent of the children who received the investigational DTaP-IPV vaccine and 18 percent of the children who received the separately administered DTaP and IPV vaccines. In addition, incidence of swelling with increased upper arm circumference at the DTaP-based injection site was 0.6 percent in the investigational DTaP-IPV vaccine group and one percent in the separately administered DTaP and IPV vaccines group.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world’s children, from up to six diseases in one vaccine.

IPOL® is a registered trademark of Sanofi Pasteur, the vaccines business of sanofi-aventis Group.

M-M-RII® is a registered trademark of Merck & Co., Inc.

GlaxoSmithKline
gsk

View drug information on INFANRIX. Continue reading →

Gilead Sciences, Inc. (Nasdaq:GILD) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of aztreonam lysine for inhalation (75 mg three times daily), an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. The NDA is supported by data from two Phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2. Aztreonam lysine for inhalation is delivered by the eFlow® Electronic Nebulizer (PARI GmbH).

“Chronic pseudomonal airway infection represents the single greatest cause of morbidity and mortality for people with cystic fibrosis, and with a limited number of inhaled antibiotics, there remains a significant unmet medical need,” said A. Bruce Montgomery, MD, Senior Vice President, Head of Respiratory Therapeutics, Gilead Sciences. “The completion of this new drug application is reflective of Gilead’s commitment to developing novel therapies for people with this life-threatening disease.”

Data from AIR-CF1 demonstrated improvement in respiratory symptoms for people with cystic fibrosis as measured by the Respiratory Symptoms scale of the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool used to measure health-related quality of life for people with cystic fibrosis. AIR-CF2 data demonstrated that aztreonam lysine for inhalation significantly delayed the time to need for inhaled or intravenous (IV) antibiotics following a course of inhaled tobramycin. Both studies also demonstrated improvements from baseline in respiratory function, as measured by relative improvement of forced expiratory volume in one second (FEV1) compared to placebo.

The most common treatment-emergent adverse events in the AIR-CF studies were cough, productive cough, nasal congestion, wheezing and sore throat. The incidences of these events were not significantly different between the placebo and the aztreonam lysine for inhalation groups.

In August 2007, Gilead initiated an expanded access program (EAP) to provide aztreonam lysine for inhalation to people with cystic fibrosis and P. aeruginosa who have limited treatment options and are at risk for disease progression.

Aztreonam lysine for inhalation is an investigational therapy and has not yet been determined safe or efficacious in humans.

About the Expanded Access Program

The EAP is open to treatment centers in the United States for people with cystic fibrosis who are six years or older and have P. aeruginosa present in expectorated sputum or throat swab culture within two months prior to consent. The Cystic Fibrosis Foundation, through its affiliate pharmacy, Cystic Fibrosis Services, Inc. is assisting in drug distribution to treatment centers.

People with cystic fibrosis in the U.S. with severe lung function impairment as defined as having an FEV1 of less than 50 percent predicted or who have completed participation in the open-label AIR-CF3 trial are eligible to participate.

Participating patients are evaluated at screening, at baseline, at Day 28 and at Day 56 visits, and then every two months thereafter. In this program, patients will receive aztreonam lysine for inhalation, administered via the PARI eFlow Electronic Nebulizer, 75 mg three times daily, in 56-day cycles of therapy (28 days on drug followed by 28 days off) as provided by their physician until patients or physicians withdraw from participation in the study or the program is terminated by Gilead.

For more information regarding the expanded access program or to request registration materials, physicians log on to EAPforCF.

About the AIR-CF Phase III Program

The Phase III AIR-CF clinical program was designed to determine the safety and efficacy of aztreonam lysine for inhalation for use in people with cystic fibrosis who have pulmonary P. aeruginosa. In each of these studies, aztreonam lysine for inhalation was administered by the PARI eFlow Electronic Nebulizer.

AIR-CF1 was a double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course of aztreonam lysine for inhalation in people with cystic fibrosis who have pulmonary P. aeruginosa. The primary endpoint was the change at day 28 from baseline in respiratory symptoms as assessed by the CFQ-R. This study enrolled 164 patients who were randomized to receive 28 days of treatment with aztreonam lysine for inhalation or volume-matched placebo administered three times daily.

AIR-CF2 was a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine for inhalation following a 28-day treatment course of tobramycin inhalation solution in people with cystic fibrosis who have pulmonary P. aeruginosa. Patients were randomized to receive 28 days of treatment with 75 mg of aztreonam lysine for inhalation or volume-matched placebo each administered two times or three times daily. Patients were followed for an overall study period of 126 days, with 56 days of observation after receiving aztreonam lysine for inhalation therapy or placebo.

AIR-CF3 is an open-label, multi-center study of patients who participated in the AIR-CF1 or AIR-CF2 studies. The primary objective of the study is to evaluate the safety of repeated exposure to aztreonam lysine for inhalation in people with cystic fibrosis. Patients will receive treatment with aztreonam lysine for inhalation with the same dosing regimen they received in AIR-CF1 or AIR-CF2. This trial is ongoing.

About Aztreonam Lysine for Inhalation

Aztreonam lysine for inhalation is an antibiotic candidate currently being studied in an ongoing Phase III open label trial for people with cystic fibrosis who have pulmonary P. aeruginosa. Aztreonam has potent activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is a FDA-approved agent for intravenous administration. Aztreonam lysine for inhalation is a proprietary formulation of aztreonam developed specifically for inhalation and has been designated with orphan drug status in the United States and Europe.

About PARI Pharma and the eFlow Electronic Nebulizer

Aztreonam lysine for inhalation is delivered by a novel inhalation device, the eFlow Electronic Nebulizer, developed by PARI Pharma GmbH. eFlow is a quiet, portable nebulizer that enables efficient aerosolization of liquid medications via a vibrating, perforated membrane. PARI Pharma also contributed to the development and optimization of the drug formulation (aztreonam lysine for inhalation) for delivery via eFlow. Based on PARI’s 100-year history working with aerosols, PARI Pharma is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.

About Cystic Fibrosis

Today, more than 30,000 people in the United States have CF. CF is a chronic, debilitating genetic disease. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs that traps bacteria and predisposes patients to lung infections, which damage their lungs. Pulmonary infection with Gram-negative bacteria, particularly pulmonary P. aeruginosa, represents the single greatest cause of morbidity and mortality among CF patients. Currently there is no known cure for CF, and the goal of CF therapy is to control symptoms and prevent further lung damage.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that the FDA may not approve aztreonam lysine for inhalation for treatment of people with cystic fibrosis (CF) who have pulmonary P. aeruginosa infection. In addition, marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2006 and Quarterly Reports on Form 10-Q for the first, second and third quarters of 2007, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

gilead Continue reading →

New research describes a molecular tool that shows great promise as a therapeutic for human acute myeloid leukemia (AML), a notoriously treatment-resistant blood cancer. The study, published by Cell Press in the July 2nd issue of the journal Cell Stem Cell, describes exciting preclinical studies in which a new therapeutic approach selectively attacks human cancer cells grown in the lab and in animal models of leukemia.

AML is a cancer of the white blood cells that has an extremely poor prognosis and does not respond well to conventional chemotherapy. “The cellular and molecular basis for this dismal picture is unclear,” offers senior study author Associate Professor Richard Lock from the Children’s Cancer Institute Australia and the University of New South Wales. “However, previous research has suggested that leukemia stem cells (LSCs) may lie at the heart of post-treatment relapse and chemoresistance.” LSCs are cells that can initiate AML and are critical for its long-term growth.

Associate Professor Lock and colleagues exploited the fact that the molecule CD123 is expressed at very high levels on LSCs but not on normal blood cells. CD123 is part of the interleukin-3 receptor, a protein that interacts with a growth factor (called a cytokine) that influences cell survival and proliferation. The researchers created a therapeutic antibody that recognized and bound to CD123 with the hope that this antibody would selectively interfere with AML-LSC survival.

When AML-LSCs from human patients were transplanted into mice treated with the antibody, called 7G3, cytokine signaling in the tumor cells was blocked. Further, 7G3 impaired migration of the AML-LSCs to bone marrow and activated the innate immune system of the host mouse to destroy the AML-LSCs. Overall, treatment with 7G3 substantially improved mouse survival when compared with control groups. The researchers go on to report that a CD123-targeting antibody is currently being used in phase 1 clinical trials of advanced AML and that there are no signs of treatment-related toxicity.

These results hold substantial promise for future cancer therapeutics. “The recent characterization of defined populations of cancer stem cells in a range of human malignancies, as well as their relative resistance to conventional chemotherapy and radiotherapy, supports the broad applicability of our approach and provides rationale for the progression of AML-LSC-targeted therapeutics from preclinical evaluation to clinical trials,” concludes Associate Professor Lock.

The researchers include Liqing Jin, University Health Network, Toronto, Canada; Erwin M. Lee, University of New South Wales, Sydney, Australia; Hayley S. Ramshaw, Centre for Cancer Biology, Adelaide, Australia; Samantha J. Busfield, CSL Limited, Melbourne, Australia; Armando G. Peoppl, University Health Network, Toronto, Canada; Lucy Wilkinson, Queensland Institute of Medical Research, Brisbane, Australia; Mark A. Guthridge, Centre for Cancer Biology, Adelaide, Australia; Daniel Thomas, Centre for Cancer Biology, Adelaide, Australia; Emma F. Barry, Centre for Cancer Biology, Adelaide, Australia; Andrew Boyd, Queensland Institute of Medical Research, Brisbane, Australia; David P. Gearing, CSL Limited, Melbourne, Australia; Gino Vairo, CSL Limited, Melbourne, Australia; Angel F. Lopez, Centre for Cancer Biology, Adelaide, Australia; John E. Dick, University Health Network, Toronto, Canada; and Richard B. Lock, University of New South Wales, Sydney, Australia.

Continue reading →