By combining three previously unrelated imaging tools into one new device, a team of researchers from the University of Connecticut and the University of Southern California has proposed a new way to diagnose early-stage ovarian cancer in high-risk women through minimally invasive surgery. The new technique may be better than the current standard procedure of preemptively removing the ovaries.

Ovarian cancer has a low survival rate because a lack of reliable screening techniques usually means the disease remains hidden until the later stages. Now researchers have drawn on the unique advantages of multiple imaging tools to test a new way of spotting early-on the tissue irregularities that signal cancer.

For their diagnostic device, the researchers combined the contrast provided by photoacoustic imaging, the high-resolution subsurface imaging provided by optical coherence tomography, and the deeper tissue imaging provided by pulse-echo ultrasound. They tested their device, described by the team in the September issue of the Optical Society’s (OSA) open-access journal Biomedical Optics Express, by imaging both pig and human ovarian tissue, and correctly identified malignant tumors that were later confirmed by staining the tissue and examining it under a microscope. These initial tests were performed on tissue that had been surgically removed, but the diameter of the device – at only 5 mm – is small enough that it could potentially be inserted through a small slit to image tissue in live patients. Continue reading →

Wine drinkers in England are consuming about 2,000 calories just from booze each month, according to a new study. A significantly large proportion of these people are not aware of the calories that pile up when consuming wine. They are the equivalent to consuming an extra 38 roast beef dinners or 184 bags of crisps.
Implications for women

42% of women do not know that a glass of white wine has the same number of calories as a bag of crisps, according to the Government’s Know Your Limits campaign.
Two large glasses of white wine represent more than the daily recommended alcohol limit for women.
At 370 calories, two large glasses of wine make up nearly one fifth of an average woman’s daily calorie allowance.

Implications for men

40% of men not know that a pint of lager has the same number of calories as a sausage roll.
A man who consumes five pints of lager a week is consuming an extra 44,200 calories per year.
5 pints of lager a week are equivalent to the calories of 221 doughnuts in one year.

Alcohol makes people hungry, adding even more calories

37% of drinkers say that alcohol triggers them to eat more.
Over a third of drinkers say that on a day they drink over the daily recommended limit they are much more likely to ditch a healthy diet.
29% of drinkers order nuts, pork scratching, or crisps when they are having an alcoholic drink.
19% of drinkers will regularly grab a takeaway (takeout) pizza, burger, kebab or bag of chips (French fries) when they consume over two glasses of wine or two pints of beer.

More calories the morning after
According to the new Know Your Limits figures, people tend to consume more calories the following morning.

62% of people who usually have muesli or a bowl of cereal for breakfast will go for less healthy options to help them through a hangover. 28% say they turn to a fry-up, bacon or sausage sandwich, or takeaway breakfast from a fast-food chain. Swapping a bowl of cereal for a fry-up can add an extra 450 calories, on top of the alcohol calories consumed the night before.

Health Minister, Phil Hope said “Regularly drinking more than our recommended daily limits can have a knock on effect on our health – including an expanding waistline. It’s not only the calories in the drinks themselves that can help to pile on the pounds, we’re also more likely to eat fatty foods when we’ve had one too many. To avoid piling on the pounds we should try to drink within the recommended limits, eat a healthy diet and exercise regularly.”

Heather Caswell, spokesperson for the British Nutrition Foundation said “Many women don’t know that two large glasses of white wine not only puts them over the recommended daily limit for alcohol consumption, but also provides them with nearly 20 per cent of their daily calorie allowance, at approximately 370kcals in total. Most people would baulk at consuming a full glass of single cream, but wouldn’t think twice about a couple of pints. But the calorie content is similar and, over time, excess alcohol intake is likely to lead to weight gain. Sticking to sensible drinking habits and keeping to the recommended units will not only help keep off those extra pounds but will also help decrease your risk of serious health problems, such as some types of cancer and liver disease.”
Here are some tips from the British Nutrition Foundation:

Adhere to the maximum daily recommended units for alcohol consumption – 3 to 4 units per day for men and 2 to 3 units per day for women. A 250ml glass of wine with an alcohol content of 12% contains 3 units of alcohol, while a pint of beer with an alcohol content of 5.2% contains 3 units.
To prevent you becoming dehydrated, alternate between an alcoholic drink and a glass of water.
Try not to drink on an empty stomach. However, try to pick foods that are good for you.
Drink at your own pace rather than in rounds – you most likely consume more if you drink in rounds.
If you are trying to cut down your alcohol consumption, you are more likely to succeed long-term if you do so with a friend.
Have a healthy meal before you start drinking. You are less likely then to grab calorie filled snacks later on.
Take small sips rather than large gulps.
Do not save your units for the end of the week. If you do you are binge drinking – this is very bad for you.
Mix non-alcoholic liquids in with your drink. If you are having a glass of white wine add some soda water.

Know Your Limits is a joint Department of Health and Home Office initiative, launched in October 2006

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A vaccine for treating a recurrent cancer of the central nervous system that occurs primarily in the brain, known as glioma, has shown promising results in preliminary data from a clinical trial at UCSF Medical Center.

Findings from the first group of six patients in the study, being conducted at the UCSF Brain Tumor Research Center, showed that vitespen (trademarked as Oncophage), a vaccine made from the patient’s own tumor, was associated with tumor-specific immune response in patients with recurrent, high-grade glioma.

Glioma is a type of primary tumor that arises from the glial cells, the connective tissue cells that surround and support nerve cells. The most common site of involvement of a glioma is the brain. Malignant glioma is currently a fatal disease.

The trial results were presented at the Immunotherapy Task Force Meeting, sponsored by the Society of Neuro-Oncology and the Joint Section of Tumors, during the Society’s 11th annual scientific meeting in Orlando, Fla., on November 16, 2006.

“This is the first documentation of a glioma-specific immune response after vaccination with vitespen,” said Andrew T. Parsa, MD, PhD, assistant professor in the UCSF Department of Neurological Surgery and principal investigator of the trial.

“Based on preliminary observation of patients in the first cohort, the tumor-specific immune response evoked by vitespen vaccination may be associated with clinical benefit in these patients with recurrent glioma, including improved progression-free survival and overall survival compared with historical controls. Further studies are certainly warranted to definitively determine the benefit of vitespen in this patient population,” he said.

Derived from each individual’s tumor, vitespen contains the “fingerprint” of the patient’s particular cancer and is designed to reprogram the body’s immune system to target only cancer cells bearing this fingerprint. The vaccine is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Vitespen has been granted fast track and orphan drug designations from the Food and Drug Administration in both metastatic melanoma (skin cancer) and renal cell carcinoma (kidney cancer).

The UCSF clinical trial is a phase1/2 study designed to establish the feasibility, safety and preliminary efficacy of vaccination in patients with recurrent, high-grade glioma. The trial involves two groups of six patients, both of which receive a minimum of four injections: the first group receives biweekly vaccinations and the second receives weekly vaccinations. Patients are monitored for immune response before, during and after treatment.

In the first group, study results showed tumor-specific immune response was detected after vaccination in all six patients. Researchers observed that patients whose disease was stable after surgical resection and before vaccination were more likely to respond clinically. Of the first six patients treated, five have exceeded the historical median benchmark of 6.5 months survival from time of recurrence. All six have exceeded the overall survival historical benchmark of 14.6 months from time of diagnosis.

The UCSF investigators will continue to follow patients for progression-free survival and overall survival. According to investigators, no adverse events or toxicity identified were considered attributable to the vaccine. Based on these preliminary findings, a larger phase 2 study is planned for 2007.

Rosalind Hekkala, a 66-year-old woman from Reno, Nev., who was enrolled in the first study group, was originally diagnosed with a brain tumor in July 2005. She had surgery to remove it, but the tumor returned in November. Her daughter learned of the trial at UCSF and Hekkala enrolled. In January 2006 she had another surgery, and this time, the removed tissue was sent to Antigenics, the Massachusetts biotech company that produces the vaccine from the patient’s tumor tissue. Because of the size of the tumor, Hekkala will receive injections every other week until mid-February. So far, results are promising with no sign of tumor regrowth, according to the Parsa.

“Every day I feel better,” Hekkala said on a recent visit to UCSF to receive her injection. “I set small goals for myself and I keep meeting them. I am very hopeful that this vaccine is the answer.”

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The clinical trial was funded the American Brain Tumor Association and the National Cancer Institute’s Specialized Program of Research Excellence.

UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.

Contact: Carol Hyman

University of California – San Francisco Continue reading →

About 1000 Australian males and females of all ages were tested for their ability to detect or identify a range of different odours at different concentrations, and then given an overall score for their sense of smell, or olfactory function.

The results showed that olfactory function deteriorates relatively slowly with age in those who do not smoke, take medications or have a history of nasal problems such as sinusitis.

However the ability to smell drops off much quicker in older people who were taking medications – also an indicator of underlying health problems.

Researcher Dr Amy Johnston, from Griffith University’s School of Nursing and Midwifery and the Eskitis Institute of Cell and Molecular Biology, said the study suggested that aging alone had a small detrimental effect on smell.

“However our sense of smell is vulnerable to both the direct effects of some medications and changes associated with a number of neurodegenerative illnesses. Exposure to these factors typically increases with age.”

Anticholesterol and blood pressure lowering medications were amongst the common drugs known to interfere with smell. Conditions such as Parkinson’s disease and Alzheimer’s disease were also associated with impairment in the sense of smell, she said.

Dr Johnston said the ability to smell was an important factor in the enjoyment of food flavours.

“People who lose their sense of smell, particularly the elderly, are at risk of poor appetite and subsequent poor nutrition. Smell is also an important warning sense – telling people when food is not fit for consumption.”

Healthy women were shown to have a more sensitive sense of smell than healthy men but the gender effect was not apparent in smokers, people on medications or with a history of nasal problems.

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The study was published in the journal Chemical Senses. Dr Johnston and other members of the Clinical Neurology group continue their research focusing on the impact of common medications on the sense of smell.

Contact: Dr. Amy Johnston
Research Australia Continue reading →

Eric Shaqfeh studies blood at Stanford University, using computer models that simulate how the fluid and the cells it contains move around. On November 11 at a meeting of the scientific society AVS, he will present his latest unpublished findings from two studies. One shows how components in blood line up to prepare for healing; the other demonstrates the best shape to use for man-made nanoparticles that target cancers — a surfboard.

The different components that move through our blood stream are not evenly distributed. For years, scientists have known that platelets — which help blood to clot — stay close to the walls of blood vessels as they circulate.

“When somebody cuts himself, the fact that the platelets are sitting seven times more frequently at the edges of the little blood vessels is critical,” says Shaqfeh.

His models suggest that when a new platelet is made, it takes longer than expected to migrate to and line up at the edge — as much as ten or fifteen minutes to establish “hemostatis,” in which blood cells are properly distributed in the body. The research, funded by the Army, suggests that current techniques for blood transfusions may not be ideal. Freezing platelets, which is common practice, may change their shape and disrupt their movements, and there may be better ways to give transfusions that establish the proper blood arrangement faster, says Shaqfeh.

In related work, Shaqfeh added tiny nanoparticles of various sizes and shapes into his blood models. Such particles are of interest to the cancer researchers, who hope to use nanoparticles to target the walls of blood vessels that feed tumors. Shaqfeh found that surfboard-shaped particles stayed closest to the walls of blood vessels. He will soon be working with another group to test fluorescent surfboard-shaped particles in actual blood vessels to see how they behave.

The talk “The Microfluidics of NonSpherical Colloidal Particles and Vesicles with Application to Blood Additives” is at 11:20 a.m. on Wednesday, November 11, 2009. Abstract

Full meeting program

Main meeting page

Source: Jason Bardi

American Institute of Physics Continue reading →

When forming myelin, oligodendrocytes have a big job in creating all that membrane. Specialized proteolipid protein (PLP) components of myelin membranes are expressed in the absence of neurons, but an unknown diffusible neuronal factor triggers a switch in PLP trafficking.

This week, Kippert et al. investigated the trafficking of PLP from late endosomes/lysosomes (LEs/Ls) to the plasma membrane. The authors used Oli-neu cells, an oligodendroglial line stably expressing fluorescently labeled PLP (PLP-EGFP). Conditioned media from primary neuronal cultures triggered cell differentiation and PLP-EGFP redistribution. Inhibition of tyrosine kinases or Rho GTPase also triggered PLP-EGFP movement, and the addition of neuronal-conditioned medium reduced RhoA activity.

In immature oligodendrocytes, Rho mediated clathrinin-independent endocytosis, but upon differentiation, Rho activity and the endocytotic pathway were downregulated in favor of LE/L vesicle mobilization. The authors propose that endocytosis is a control point for the massive requirement for membrane in myelin.

###

Angelika Kippert, Katarina Trajkovic, Lawrence Rajendran, Jonas Ries, and Mikael Simons

Source: News tips from the Journal of Neuroscience

Contact: Sara Harris
Society for Neuroscience Continue reading →

If you are going on a long plane trip you could benefit from wearing sunglasses as they can reduce the effects of jet-lag, say researchers from the Edinburgh Sleep Centre, Scotland. It seems that by altering your light patterns you can tweak your body-clock to adjust to new time zones more easily.

Researchers examined one thousand passengers on long-haul flights. They found that for every hour difference when you travel westwards it takes a day to recover from the effects of jet-lag (without sunglasses).

Dr. Chris Idzikowski, study leader, said that jet lag is a physical thing – not something made up. He said the biological clock is 20,000 nerve cells in the brain.

The researchers found that travellers recovered faster if they wore sunglasses during some their trip.

When you travel westwards your day is much longer. If you fly from London to New York, your 24 hour day becomes a 29 hour day. When you travel east the day becomes shorter. Travelling eastwards is harder to recover from.

The researchers have devised a chart which tells passengers how long they should wear their sunglasses for, depending on their trip.

Dr Idzikowski said “The internal body clock steps up at dawn which is when we can manipulate exposure to light, it’s a way of fooling the biological clock.”

He added that immigration officials often ask you to take your sunglasses off – this can weaken the benefits.

This study was carried out by the Edinburgh Sleep Centre on behalf of British Airways.

edinburghsleepcentre

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GE Healthcare along with Olympic medical leaders announced at the Beijing 2008 Olympic Games, initial findings that recognize risks for sudden cardiac death and musculoskeletal injuries before they happen. The findings come from two Olympic athlete research studies conducted since the Torino 2006 Olympic Winter Games aimed at demonstrating that health monitoring and early intervention may lead to injury prevention and enhanced health.

Athlete Heart Research Provides Insight into Sudden Cardiac Death

Dr. Malissa Wood, cardiologist, Massachusetts General Hospital in Boston announced that their work with Olympic athletes have allowed them to identify healthy patterns of heart enlargement that can differentiate it from hypertrophic cardiomyopathy. Previously, it was believed that heart size is indicative of risk of Sudden Cardiac Death (SCD); however, Dr Wood’s research with the USA Weightlifting and U.S. Men’s Rowing teams has shown that it is the health of the systolic or blood-pumping action – not the heart size – that is the distinguishing factor of a healthy heart. This study is being conducted using GE Healthcare’s Vivid i cardiac compact ultrasound technology.

“As a result of these findings, we are in the process of developing a cardiac fitness index to be released later this year that will help trainers and coaches understand how cardiac conditions impact performance of high-endurance athletes,” said Dr. Wood. “Our work also will provide healthcare professionals with insight into new, more effective ways of assessing and treating heart disease for the general public.”

Based on Dr. Wood’s findings, Dr. Patrick Schamasch, medical director of the International Olympic Committee (IOC), has recommended routine cardiac monitoring of Olympic athletes. “I fully support the action to have preparticipation cardiovascular screening mandatory for elite athletes. This will evaluate athletes before participating in sports for the purpose of identifying (or raising suspicion of) abnormalities that could provoke disease progression or sudden cardiac death. Ensuring the well-being of all athletes is the IOC’s priority, and we feel that the identification of the relevant diseases will allow clinicians to make decisions earlier on, of whether a player can stay in the game or not, but above all tailor their training programs to best meet their needs and ensure athlete safety.” Dr. Schamasch, Medical and Scientific Director, International Olympic Committee (IOC).

Asymptomatic Injury Detection Key for Increasing Athlete Performance

Since 2005, Dr. Marnix van Holsbeeck from the Henry Ford Health System in Detroit has been studying how ultrasound scans can identify weaknesses in an athlete’s musculoskeletal structure before an injury occurs. Initial results from this research has demonstrated an incidence of asymptomatic injuries in several of the athletes; in a higher than expected incidence in female athletes. This study is being conducted with athletes from the USA Weightlifting, USA Boxing, and the U.S. Women’s National Soccer teams using GE Healthcare’s LOGIQ i ultrasound technology.

“We were surprised to find that athletes who trained at the highest level with no sign of pain showed early signs of potential injury during routine scanning,” said van Holsbeeck. “We’ve found that ultrasound technology can highlight problems with structure and with mobility of tissues that no other examination technique can show.”

“We train so hard as athletes that little injuries can lead to further injuries,” said Heather Mitts, defender on the U.S. Women’s National Soccer Team, who participated in Dr. van Holsbeeck’s research study. “Through these routine scans, we can know if we should sit out, but if we know that we can keep going, we can train at the highest level.”

In line with GE Healthcare’s ‘Early Health’ vision and its commitment to sports medicine, these imaging technologies can assist clinicians to better understand the human body of elite athletes and the general public.

“If we can move toward predictive healthcare and early detection of disease, we have the potential to dramatically reduce the risks of late-stage disease treatment,” said Omar Ishrak, President & CEO Clinical Systems, GE Healthcare. “Shifting resources to develop technologies that allow healthcare providers to diagnose disease at the earliest possible stage, when there can be many treatment options, is better medicine,” added Ishrak.

About GE and the Olympic Games

GE is the exclusive provider of a wide range of innovative products and services that are integral to staging a successful Olympic Games. GE works closely with host countries, cities and organizing committees to provide infrastructure solutions for Olympic venues including power, lighting, water treatment, transportation and security, and to supply hospitals with ultrasound and MRI equipment to help doctors treat athletes. In addition, NBC Universal, a division of GE, is the exclusive U.S. media partner of the Olympic Games, with its partnership also extending through 2012. For more information, visit www.ge/olympicgames.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics and patient monitoring systems is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare’s broad range of products and services enables healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE:GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

GE Healthcare
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Doctors mostly agree that there is something inequitable about Medicare’s current reimbursement system – the consensus goes across the whole country – however, their opinions on how it should be reformed vary considerably and the likelihood of any agreement at this moment appears distant, researchers wrote in the peer-reviewed journal Archives of Internal Medicine.

The authors explain as background information:

Across the political spectrum, there is general agreement that the cost of health care has risen to untenable levels and is threatening the future of Medicare and the economic well-being of the United States.

Approximately one-fifth of health care costs go towards doctors. However, because of the nature of their work, they trigger other expenses. Hence, a considerable number of reform suggestions are aimed at clinician reimbursement as a way of saving money and improving care.

Some reformers have proposed financial bonuses for attaining quality standards, as well a system of fines for providing poor quality care, grouping episodes of care into fixed payments, and making care organizations more accountable.

Alex D. Federman, M.D., M.P.H., of Mount Sinai School of Medicine, New York, and team carried out a survey of doctors nationwide between June 25 and October 31 2009 – the physicians were randomly selected. They were asked:

Under Medicare’s current reimbursement system are some procedures reimbursed too highly?
Under the current system, are some reimbursements for procedures too low to cover costs?
They were also offered various reform proposals and asked to rate them

1,222 (48.5%) out of 2,518 doctors responded to the survey. 78.4% of them agreed that Medicare’s current reimbursement system did not fairly represent costs of procedures. Regarding reform proposals, however, the authors wrote that “there was little unity regarding support for physician payment reform proposals.”

49.1% of doctors agreed there should be financial incentives for quality care – the proposed reform with greatest consensus.

The researchers wrote:

Actual experience with financial incentives to improve quality could have directly informed physicians’ generally more positive views of these types of reimbursement mechanisms.

41.6% agreed that payments should be moved from procedures to management and counseling services, but agreement varied widely between surgeons (16.6%) and generalists (66.5%).

The authors added:

As expected, those who conduct procedures were against it, and those who do more management and counseling were for it.

Highlighted below are some details on doctors’ opinions regarding reforms:

69% opposed bundling
15.2% of surgeons supported bundling
79.8% supported more pay for generalists
Only 39.1% agreed to make up for this increase in pay for generalists with a 3% drop in specialist reimbursement

The authors concluded:

Overall, physicians seem to be opposed to reforms that risk lowering their incomes. Thus, finding common ground among different specialties to reform physician reimbursement, reduce health care spending and improve health care quality will be difficult. Research that clarifies the tradeoffs physicians would be willing to accept in payment reform, and other concerns, may help refine the design of payment reforms and improve acceptance among physicians.

“Physicians’ Opinions About Reforming Reimbursement – Results of a National Survey”

Alex D. Federman, MD, MPH; Mark Woodward, PhD; Salomeh Keyhani, MD, MPH
Arch Intern Med. 2010;170(19):1735-1742. doi:10.1001/archinternmed.2010.369

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Synta Pharmaceuticals Corp.,
a biopharmaceutical company focused on discovering, developing, and
commercializing small-molecule drugs to treat severe medical conditions,
today announced positive data from a Phase 2b study in metastatic melanoma
for STA-4783, a first-in-class heat shock protein 70 (Hsp70) inducer that
activates natural killer (NK) cell-mediated tumor killing. In the
double-blind, randomized, controlled trial in patients with Stage IV
disease, STA-4783 plus paclitaxel doubled progression-free survival (PFS),
the prospectively defined primary study endpoint, compared to paclitaxel
alone.

“These positive Phase 2b results in metastatic melanoma, a devastating
cancer with an extremely poor prognosis and limited treatment options, are
very encouraging,” said Steven O’Day, MD, Chief of Research and Director of
Melanoma at The Angeles Clinic and Research Institute in Los Angeles and
Principal Investigator for the study. “Metastatic melanoma has proven
resistant to many therapeutic approaches and pharmaceutical agents. To my
knowledge, this study is the first in metastatic melanoma to demonstrate
increased progression-free survival by a small molecule in a double-blind,
randomized, controlled trial.”

The Phase 2b study of STA-4783 was conducted at 21 U.S. clinical sites
and enrolled 81 patients with Stage IV metastatic melanoma. Study
participants were randomized in a 2:1 ratio to receive STA-4783 plus
paclitaxel or paclitaxel alone, respectively. Patients were dosed
intravenously once-a-week for three weeks followed by one week off therapy,
until disease progression. The prospectively-defined primary efficacy
endpoint was PFS. Based on the intent-to-treat (ITT) analysis, median PFS
for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days
for those receiving paclitaxel alone, a statistically significant
difference (p=0.035) that met the primary endpoint. STA-4783 was
well-tolerated in the study, with adverse events typical of those expected
for paclitaxel alone.

“We are encouraged that our first-in-class anticancer compound,
STA-4783, has demonstrated clinical benefit in a robust, well-controlled
study,” said Safi Bahcall, Ph.D., President and CEO of Synta. “The
possibility that this drug could make a difference for metastatic melanoma
patients, who have very limited treatment options today, is exciting to all
of us involved with the program. We look forward to collaborating closely
with regulatory agencies and our medical advisors to advance development of
this drug candidate expeditiously.”

Full trial results will be presented by Dr. O’Day at the joint
Perspectives in Melanoma X and the Third International Melanoma Research
Congress, Noordwijk, The Netherlands on September 16, 2006. For more
information on the Congress, visit imedex/announcements/251.asp.

Melanoma Clinical Trial Results

In a double-blind, randomized, controlled Phase 2b trial conducted at
21 study sites in the U.S., 81 patients were randomly assigned in a 2:1
ratio to receive STA-4783 in combination with paclitaxel versus paclitaxel
alone. The randomized patient populations were well balanced with respect
to demographic characteristics. Presence or absence of elevated lactate
dehydrogenase (LDH), a known poor prognostic factor, was balanced between
groups (elevated LDH for STA-4783 plus paclitaxel: 43%; paclitaxel alone:
44%). In addition, the timing of tumor progression assessments between the
two groups was equivalent.

The study demonstrated that the combination of STA-4783 with paclitaxel
reduced the risk of disease progression by approximately 50% based on the
ITT analysis (or 58% based on the PP analysis).

The secondary endpoint of objective response rate was more than three
times higher in the STA-4783 plus paclitaxel group (15.1%, ITT; 16.0%, PP)
than in the paclitaxel alone group (3.6%, ITT; 3.7%, PP), and trended
towards but did not reach statistical significance. The PFS results
observed in the paclitaxel alone arm were consistent with published
efficacy results in this disease for single-agent chemotherapy, including
dacarbazine (DTIC).

STA-4783 was well tolerated in this study; adverse events were typical
of those expected for paclitaxel alone. The most common adverse events in
the STA-4783 plus paclitaxel group included fatigue, alopecia,
constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea, and
anaemia. Certain adverse events including hypoaesthesia, neutropenia,
stomatitis, arthralgia, and fatigue — all expected from paclitaxel
treatment alone — occurred with higher incidence in the STA-4783 plus
paclitaxel group, which may be partially attributable to the longer
duration of paclitaxel treatment in this study group due to longer PFS. The
incidences of adverse events (including Grade 3 and above) were generally
comparable between the two groups.

About STA-4783

STA-4783 is an investigational, first-in-class new chemical entity that
induces the expression of heat shock protein 70 (Hsp70) on the surface of
tumor cells, which attracts natural killer (NK) immune cells and activates
NK-mediated tumor cell killing. STA-4783 acts synergistically with taxanes,
a commonly used chemotherapeutic class. In preclinical studies, STA-4783
combined with taxanes has shown activity against a range of cancers,
including breast, lung, colon, lymphoma, and melanoma. To date, STA-4783
has been administered to a total of approximately 300 patients across
multiple studies and has demonstrated an acceptable safety profile.
Additional trials in melanoma and other cancers are being planned.

About Metastatic Melanoma

Melanoma, the most deadly form of skin cancer, arises from melanocytes,
the pigment producing cells of the skin. According to the American Cancer
Society, melanoma accounts for approximately five percent of all skin
cancers but causes about 75% of all skin cancer-related deaths. An
estimated 60,000 people will be diagnosed and nearly 8,000 people will die
from melanoma this year in the U.S. alone. If diagnosed and surgically
removed while localized in the outermost skin layer, melanoma is
potentially curable; however, for patients with deeper lesions or
metastatic disease, the prognosis is poor, with limited available
treatments and an expected survival of only six to nine months. The
incidence of melanoma has increased more rapidly than any other cancer
during the past ten years. The last novel, small-molecule drug to treat
patients with this disease was approved by the FDA over 30 years ago.

About Synta Pharmaceuticals

Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on
discovering, developing, and commercializing small molecule drugs to extend
and enhance the lives of patients with severe medical conditions, including
cancer and chronic inflammatory diseases. Synta has a unique chemical
compound library, an integrated discovery engine, and a diverse pipeline of
internally-developed drug candidates targeting large therapeutic markets in
clinical and preclinical development. For more information, please see
syntapharma

Synta Pharmaceuticals Corp.
syntapharma
imedex/announcements/251.asp Continue reading →