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ScienceDaily (Nov. 30, 2007) — A new test could give doctors a head start in diagnosing those patients most likely to suffer a heart attack.
The test, developed at the University of Leeds, could result in fewer patients needlessly admitted to hospital — enabling medics to concentrate on those most needing their help.
Alistair Hall, Professor of Clinical Cardiology at Leeds, explained: “Casualty departments regularly see patients presenting with chest pains. The highest-risk patients are easy to diagnose and are admitted straight away. Those with no risk of having a heart attack are also easy to spot. It’s the group in between which is hardest to correctly diagnose. Typically patients are admitted for 24 hours while the hospital figures out the cause.”
The most commonly-used diagnostic tool is the troponin test which can detect and evaluate heart injury and separate it from chest pain due to other causes. Essentially if troponin proteins are found in the patient’s blood, then it indicates a heart problem. But Prof Hall explained that the troponin test can give both false negative and false positive results, meaning some patients are unnecessarily admitted, and others wrongly discharged.
A new test, developed at Leeds through research funded by the British Heart Foundation, searches for a heart-type fatty acid-binding protein (H-FABP) which is released into the circulation following heart injury (myocardial ischemia). Prof Hall said: “The H-FABP test is a major advance on what we had before. It appears to be able to detect milder and earlier degrees of heart injury than do current tests which detect heart cell death.”
The team’s findings are published in the American Journal of Cardiology: “Our paper shows that it is possible to be more effective in matching life-saving treatments to the patients with heart attacks who most likely to benefit from them,” said Prof Hall.
The test also enables medics to identify patients whose chest pains are an indication that they are susceptible to heart attack in the weeks and months ahead. “If you can pick these problems up in advance you could have a three-month head start in putting prevention in place,” he added.
“The study was conducted in UK in the context of a national health care system that forces hard decisions to be made regard the best use of limited resources. This blood test, which will cost about £10, could be used by ambulance crews to test people on the way to hospital. This test will enable us to send the right people home earlier and make sure we aren’t admitting people who don’t need to be admitted.
“We are excited about these findings as we believe that they will help us to provide very real benefits for patients and those who care for them.”
Professor Peter Weissberg, Medical Director at the British Heart Foundation (BHF), said: “Currently doctors rely on tests such as an electrocardiogram (ECG) and blood tests to know if a patient with chest pain has suffered any heart damage.
“This new blood test would appear to be able to more accurately identify patients with heart damage at an earlier course of their illness. If further research confirms its superiority over current tests, it has the potential to improve diagnosis and identify those people who require intensive investigation and treatment to prevent further problems.”
Heart-Type Fatty Acid-Binding Protein Predicts Long-Term Mortality After Acute Coronary Syndrome and Identifies High-Risk Patients Across the Range of Troponin Values by Niamh Kilcullen, Karthik Viswanathan, Rajiv Das, Christine Morrell, Amanda Farrin, Julian H. Barth, Alistair S. Hall is published in the American Journal of the American College of Cardiology.
Adapted from materials provided by University of Leeds.

Fausto Intilla
www.oloscience.com

The results of the study conducted in the USA. to determine the efficacy and tolerability of Relieva® in adult patients with Atopic Dermatitis (eczema) were just published in the September issue of the American Journal of Therapeutics (14:442-446, 2007).

Previous laboratory studies showed that Psorberine®, the active ingredient of Relieva®, a non-corticoid, non- immunosuppressant but potent anti-inflammatory compound might be effective in atopic dermatitis. A clinical trial was conducted to determine if indeed Relieva® is efficacious in these patients.

Patients enrolled in this 12 week trial carried out by Global Clinicals Inc. were treated with Relieva®, a topical preparation containing Psorberine in Novasome®, a proprietary liposome formulation. Efficacy and safety was assessed using EASI (Eczema Area and Severity Index), an established index used for evaluating the severity of the signs of atopic dermatitis and a Subject Reported Evaluation of Treatment. Study results showed significant improvements in Erythema, Infiltration, Excoriation and Lichenification scores. In addition, subjects responding to a post treatment evaluation questionnaire indicated a substantial benefit when rating effectiveness, itching and appearance.

This study indicates that Relieva® is useful in adult patients with atopic dermatitis.

Apollo Pharmaceuticals continuous research in dermatology offers another option for the treatment of adult patients with Atopic Dermatitis (eczema).

About Eczema

“Eczema is a cruel disease that is often mistaken as just a rash but can have a profound impact on patients’ quality-of-life and emotional well-being, particularly in children. It not only afflicts the patients, their friends and family are also affected by the emotional impact”`.

Eczema affects approximately 17% of the U.S. population and is often a distressing condition characterized by itchy, scaly, dry, inflamed skin. It is estimated that 90% of eczema patients experience symptoms before the age of 5. Many patients, especially children, experience a significant emotional impact, feeling ‘different’and/or left out. Feelings of social isolation and lack of sleep due to night-time itching demonstrate of how eczema impacts a patient’s daily live.

A global study comprised of interviews with 2,002 patients from eight countries over the age of 13, and caregivers of children between the ages of 2-13, with moderate to severe eczema showed that on average, 86% of patients avoid at least one type of everyday activity during a flare-up and 74% of patients and caregivers state that their physicians have never discussed the emotional impact that eczema has had on their lives. (http://www.nationaleczema.org)

http://www.relievaforpsoriasis.com

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It’s not a cure, but this may be some of the best news patients infected with the hepatitis C virus (HCV) have heard in a long time: A new drug, eltrombopag, appears to be effective in boosting low platelet counts, one of the major reasons why patients can’t endure antiviral treatments.

Other drugs that can restore normal platelet functions are infusions or injections; eltrombopag is a pill taken just once a day.

<span idResearchers at Duke University Medical Center and other centers world-wide studied eltrombopag (marketed as Promacta in the U.S. and Revolade in Europe by GlaxoSmithKline) in 74 patients with low platelet counts and cirrhosis of the liver due to HCV infection. They found that it boosted platelet counts in a majority of patients at each of three dosage levels, enabling most of them to continue or start conventional antiviral treatment.

The findings appear in the current issue of the New England Journal of Medicine.

“We feel this is an important development for many people infected with the hepatitis C virus world-wide,” says Dr. John McHutchison, professor of medicine and associate director of the Duke Clinical Research Institute. “A significant number of patients with HCV infection will at some point develop platelet problems that will compromise their getting the best treatments we have. Anything we can do to prevent that from happening would improve their care.”

It’s estimated that 4 million people in the U.S. and 170 million world-wide carry the hepatitis C virus. The virus causes inflammation and scarring in the liver, and while it is curable in about half of those who have it, it can lead to significant liver damage, liver cancer and death in others. HCV infection is a common cause of cirrhosis and the most common reason for a liver transplant.

Platelets are cells made in the bone marrow that are important in clot formation, and serious bleeding can occur if platelet levels fall too low. Some diseases, like HCV infection, can cripple the body’s ability to manufacture platelets, but so can some medical treatments. Cancer patients, for example, can experience plummeting platelet levels when undergoing chemotherapy.

In the phase II, multi-center trial, participants were randomized to a control group or to receive 30, 50, or 75 milligrams of eltrombopag daily. The patients had platelet levels ranging from 20,000 to 70,000 (145,000 to 450,000 is normal).

A phase II trial is designed to test the safety and efficacy of a drug at different doses, and the Duke study found that eltrombopag worked in a dose-dependent manner, meaning that patients got a better response with increasing amounts of the drug. Seventy-four percent of those in the trial who took the lowest dose saw their platelet counts go up significantly, while 79 percent and 95 percent of the participants saw increases with the higher doses.

Eltrombopag does cause side effects. Some of the patients complained of headaches, dry mouth, abdominal pain and nausea.

“We are encouraged by these results and are already working on another multi-center, international, phase III trial where we hope these results will be confirmed,” says McHutchison.

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Immutep S.A announced positive interim results from a Phase I/II study of its lead product, ImmuFact(R) IMP321 in patients with metastatic breast cancer (MBC). The data were presented at the 22nd annual meeting of the International Society for Biological Therapy of Cancer (iSBTc) in Boston.

ImmuFact(R) IMP321 is a potent natural human immunostimulatory factor designed to amplify the T cell immune response. It can be used either as an immunopotentiator in therapeutic vaccines or alone at higher doses as a monotherapy or in chemo-immunotherapy. Six clinical trials have been initiated with ImmuFact IMP321 in the last 30 months.

The clinical trial is an open-label dose-escalation study of IMP321 given the day after paclitaxel (chemo-immunotherapy). In the first cohort of eight patients, the study showed strong increases in the number of monocytes and CD8+ T cells and associated clinical responses.

This trial highlights the potential of IMP321 as a complementary immunotherapy to chemotherapy. The rationale for chemo-immunotherapy is that the chemotherapy causes apoptosis of tumour cells which releases antigens for several days. These antigens are taken up by the dendritic cell/monocyte network, the so-called antigen-presenting cells (APCs), leading to an immune response against them. By injecting an immunostimulant, especially an APC activator like IMP321, one can boost the network in order to increase the numbers of activated monocytes and CD8 T cells, both of which are endowed with anti-tumour activity.

The clinical trial is being conducted at the René Huguenin Cancer Centre, Saint Cloud, near Paris. The Principal Investigator is Dr Maya Gutierrez. It is an open-label fixed dose-escalation Phase I/II study, performed in an ambulatory setting in patients receiving as a first-line chemotherapy for MBC the standard six cycles of weekly paclitaxel (80 mg/m2 at D1, D8 and D15 of a 4-week cycle). Two IMP321 doses, 0.25 and 1.25 mg given subcutaneously, are being tested, given at D2 and D16 of this 4-week cycle, for six courses.

“Concurrent chemo-immunotherapy is a promising cancer treatment. Some preclinical and also clinical studies have shown that immunotherapy can enhance anti tumour activity of chemotherapy,” said Dr Gutierrez. “In metastatic breast cancer, taxane-based chemotherapy is considered as the gold standard first line in patients previously treated with anthracyclines in an adjuvant setting. Weekly paclitaxel is generally well tolerated and is considered to have a better therapeutic index than 3 weeks administration. Mechanisms of action combine mitotic arrest, anti-angiogenic and pro-apoptotic effects.”

The first cohort of eight patients (0.25 mg) showed that IMP321 was very well tolerated with a good efficacy profile. The clinical responses were six tumour regressions and one disease stabilization out of eight patients, to be compared to a 35 per cent response rate with chemotherapy alone. A three-fold increase in activated MHC class II+ monocyte blood counts and a two-fold increase in activated CD8+ circulating T cells were observed two weeks after the last injection in patients. Both these effects obtained in vivo mimic the in vitro effect of IMP321 on human peripheral blood mononuclear cells (see press release September 17, 2007).

“I am encouraged that such important systemic effects on both the innate (monocytes) and the adaptive (CD8 T cells) arms of the immune response could be obtained with a dose as low as a quarter of a mg,” said Frédéric Triebel, Immutep’s Scientific and Medical Director. “This is probably related to the longer protocol we are using now, incorporating 12 injections administered over six months. In fact, similar effects were previously seen in metastatic renal cell carcinoma patients (results also reported at the iSBTc meeting) with a higher dose of the product (6.25 mg) but given only six times over three months. Building-up a strong and multi-faceted anti-tumour response safely over six months or even longer in patients receiving first-line chemotherapy is the ultimate goal for IMP321. It has repeatedly been shown that cellular immunity of this type is an essential component for long-term survival.”

For further information please visit the web-site www.immutep.com.

Notes:

Metastatic Breast Cancer and Chemo-immunotherapy

Metastatic breast cancer remains incurable. The failure of current approaches is generally attributed to the outgrowth of breast tumour cells that are inherently resistant to standard treatments. Manipulating the immune system to recognize and eradicate breast tumour cells is a highly attractive alternative approach to disease management and could be associated with chemotherapy (chemo-immunotherapy) to increase response rates and survival.

The objective of the immunotherapy is to amplify natural pre-existing APCs and T cell responses specific for any known or unknown tumour antigens and also to recruit and amplify new tumour-specific T cell responses occurring during a chemotherapy cycle. The direct cytolytic effect of some cytotoxic drugs, such as paclitaxel, can enhance antigen availability by inducing tumour cell apoptosis. Until 5 years ago, it was thought that the T cell depletion caused by chemotherapy would make immunotherapy ineffective. However it has now been shown that, on the contrary, the vigorous T cell repopulation following depletion can be directed against the tumour, the so-called “rebound” effect.

Centre René Huguenin de Lutte contre le Cancer

The René Huguenin Centre for the Fight against Cancer is a comprehensive cancer centre that treats more than 3,000 new cases of cancer each year, including more than 2,000 new cases of breast cancer. It has a medical staff of 66 practitioners. Besides participating in therapeutic trials, the Centre has developed special expertise in the field of tumorigenesis and pharmacogenetics of breast cancers. Professor Jean-Nicolas Munck is the Directeur-Général of the Centre.

The LAG-3 immune control mechanism

The lymphocyte activation gene-3 (LAG-3 or CD223) protein binds to the MHC class II molecule which is at the centre of immune response induction. The LAG-3 immune control mechanism plays a role in the upregulation of the immune system through the activation of MHC class II+ antigen presenting cells like dendritic cells and monocytes (the primary target cells for IMP321) leading to the expansion of activated CD8 T cells (the secondary target cells).

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Yesterday at the 19th Annual Piper Jaffray Health Care Conference, Dr. Dennis I. Goldberg, President and Chief Executive Officer of Transport Pharmaceuticals, Inc., presented compelling clinical results of a Phase 2 study designed to evaluate the safety and efficacy of the company’s lead drug/device product, the SoloVir™ Electrokinetic Transdermal System (SoloVir™ ETS) for recurrent herpes labialis (cold sores). SoloVir™ ETS uses single-use drug cartridges containing Transport’s novel, five-percent acyclovir gel.

This unique study was designed to determine the optimum treatment protocol based upon the immediate delivery of a large bolus of acyclovir into the skin during a herpetic episode, i.e. whether treatment at either the prodrome or erythema stage on day one of the herpetic episode was significantly better than placebo. TPI-H-221 was a multi center, randomized, double blind, placebo-controlled study that enrolled approximately 260 subjects.

Dennis I. Goldberg, President and CEO, commented on the clinical results, “The TPI-H-221 study has demonstrated that treatment at the erythema or papule/edema stages, the first visible signs of a cold sore, decreased the number of patients who progressed to classical lesions, and resulted in a dramatic decrease in healing times. Patients who treated earlier, at the prodrome stage, did not see a statistically significance benefit. Our Phase 2 study provides valuable insights into the treatment of herpes labialis. SoloVir™ ETS is the only one time treatment to achieve a statistically significant and clinically meaningful decrease in herpetic lesions. This study provides a number of important findings that provide a clear path for completing the development of this novel combination drug/device product.”

Spotswood Spruance, MD, a noted expert on herpes labialis and a member of Transport’s Scientific Advisory Board, commented, “Based on two well controlled Phase 2 clinical studies, Transport may offer the clinical community a new paradigm for treating herpes more efficaciously by administering treatment to the site of viral replication at the first visible evidence of a lesion.”

Dr. Spruance continued, “There has been some controversy in the medical community about treating this patient population during the prodrome stage because as many as one third will have aborted lesions without receiving any treatment. SoloVir™ ETS may mitigate that controversy by allowing patients to wait for the first visual signs before initiating treatment, thereby treating patients with a higher probability of progression to classical lesion.”

TPI-H-221 Study Results

Data from this Phase 2 clinical study indicate that treatment at the erythema or papule/edema stages resulted in a statistically significant effect on the herpetic episode. In particular, the study demonstrated a 79 percent increase in aborted lesions (43% active; 24% placebo; p= 0.03; active n= 61; placebo n= 72) in SoloVir™ ETS treated subjects versus placebo. These subjects also experienced a 3.5 day reduction in time to complete healing (p= 0.015). Furthermore, this study demonstrated a statistically significant and clinically meaningful reduction in pain. SoloVir™ ETS was shown to be well tolerated with a compliance rate greater than 98 percent, with no serious adverse events reported related to study drug in all groups.

Based on the strong clinical results from TPI-H-221, Transport will advance SoloVir™ ETS into its next clinical stage of development in 2008. Transport has retained worldwide rights to SoloVir™ ETS for the treatment of herpes labialis.

TPI-H-221 Study Design

Patients were randomized in a 1:1:1 ratio into one of three iontophoretic treatment groups, two active arms and one placebo arm.

Primary efficacy in this patient initiated study of approximately 260 subjects was measured by duration of the herpetic episode. Prevention of progression to classical lesion, time to complete healing, and duration of pain were key secondary endpoints. Treatment phase ended after at least 80 patients in each treatment group had experienced a herpetic episode and received either drug or placebo treatment. The small size and portability of SoloVir™ ETS allowed patients to treat themselves immediately at the first signs and symptoms of a herpetic lesion with a single, ten- minute iontophoretic application of either active acyclovir gel or placebo gel. A second, investigator-supervised treatment followed 6 - 18 hours later in the clinic.

About SoloVir™ ETS

Transport’s lead product, SoloVir&trade ETS, utilizes the company’s proprietary five-percent acyclovir gel formulation to treat herpes labialis, or cold sores. SoloVir™ ETS consists of a reusable control unit and a disposable, unit-dose, single-use medicated cartridge. The small, wireless control unit uses a low voltage which is varied in response to patient skin impedance to provide constant current and control of drug delivery. The drug cartridge contains a unit dose of the drug formulation as well as the drug delivery electrode. Portability of the battery-powered device allows patients to easily self-administer topical drugs for a variety of indications. Both product and technology were developed by Transport’s scientists and engineers and are protected by a broad patent portfolio.

Pharmacokinetic data from a Phase I study (TPI-H-111) indicate that a single ten minute treatment with SoloVir™ ETS delivered more than 100 times the published peak tissue levels (2 ug/ml) of acyclovir achieved with a 1 gram dose of Valtrex®, a leading oral-antiviral drug marketed for the treatment of herpes labialis. In addition, the peak tissue levels are achieved at the time of administration with SoloVir™ ETS, while orally administered Valtrex, requires more than two hours to reach peak acyclovir levels in the skin. Results of an earlier reported, clinic-initiated proof-of-concept study with a prototype device and 5 percent acyclovir cream demonstrated a three day (or 71 hours; 49 hours versus 120 hours; p= .03) reduction in healing time among a subgroup of patients that were treated at the first visible stage of infection or erythema stage. {Clinical Infectious Diseases, August 15, 2006}.

About Herpes Labialis

Herpes labialis, also called cold sores, is caused by the herpes simplex virus, most commonly type I (HSV-1). Up to 90 percent of the U.S. population is infected with HSV-1, and approximately 30 percent suffer from recurring outbreaks. On average, a patient has four cold sore outbreaks per year. As a result, there are an estimated 360 million recurrent herpetic episodes in the U.S. per year. It is second only to the common cold in prevalence. Currently approved treatments for herpes labialis, including acyclovir cream, penciclovir cream, n-docosonal 10 percent cream, valacyclovir, the oral prodrug of acyclovir, and famciclovir, the oral prodrug of penciclovir, are all labeled to treat at the prodromal stage. None of these treatments are proven to increase the frequency of aborted lesions (aborted lesions are those that do not progress to vesicle, or ulcer stages of classical lesions).

About Transport

Transport is bringing together cutting-edge medical electronics with drug formulation and material sciences to develop drug/device combination products that enhance movement of drugs across the stratum corneum (the skin’s outer layer) by means of electric current. In addition to the lead drug/device product, SoloVir™ ETS, Transport has a pipeline of earlier stage dermatological products based on its electrokinesis platform including onychomycosis, acne, actinic keratosis, keloids, warts, psoriasis, skin cancer and medical aesthetic applications.

Transport is a Massachusetts-based, privately held specialty pharmaceutical company. Current venture investors include Quaker BioVentures, The Carlyle Group, The Hillman Company and The Halleran Company.

http://www.transportpharma.com

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Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced positive results from its Phase II octreotide implant trial in patients with acromegaly, a disorder characterized by excessive blood levels of growth hormone (GH) and insulin- like growth factor 1 (IGF-1). The implant utilizes the Company’s patented Hydron technology to deliver effective levels of octreotide for six months. Octreotide is a synthetic peptide that mimics the natural hormone somatostatin to block release of GH. In the recently completed six-month trial, the octreotide implant effectively suppressed levels of GH and IGF-1 at rates similar to those seen with current FDA approved injectable formulations of octreotide. In addition, the drug was well tolerated.

“I am extremely pleased to report the successful completion of our octreotide implant trial and we are looking forward to the initiation of our Phase III program in the first half of 2008,” stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. “The market opportunity for a six-month octreotide implant for the treatment of acromegaly is substantial. The results of the trial demonstrate the potential of our octreotide implant, the only once every six month treatment, to improve the treatment options for people who suffer from this life-long debilitating condition. In addition, based on the successful results of this trial, we are exploring opportunities to expand our octreotide development program to address other indications where injectable formulations of octreotide are currently utilized, including carcinoid tumors.”

The trial was an open-label study designed to evaluate the pharmacokinetic and pharmacodynamic response of octreotide implants in patients with acromegaly. The trial evaluated the release effectiveness of both pre- hydrated and non-hydrated (dry) implants and evaluated the suppression of growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The trial enrolled and evaluated a total of 34 patients who had previously demonstrated a full or partial GH and IGF-1 response to octreotide. Approximately half of the patients had a baseline growth hormone of <5 ng/mL on entry into the study, indicating that the prior octreotide injections were providing adequate control. In these patients, the octreotide implant successfully maintained GH at this level in 94% of patients. This response rate is similar to the rate seen with Sandostatin(R) LAR(R) (83 to 97%). Approximately 60% of these implant trial patients achieved a normal age-adjusted IGF-1 concentration. Sandostatin LAR produces a similar age-adjusted normalization of IGF-1 concentrations (51 to 67%).

The remaining patients had entered the trial with baseline GH levels >5 ng/mL, and 59% achieved GH suppression to <5 ng/mL and 35% achieved suppression to <2.5 ng/mL. This response rate is similar to the rate seen from partial responders when treated with Sandostatin LAR (32% and 4% respectively).

All enrolled patients completed the six-month trial and there were no serious or severe adverse events reported.

The trial also confirmed by pharmacokinetic analysis that there was no difference in the predictable, steady release of octreotide from either the pre-hydrated or non-hydrated octreotide implants. The Company intends to utilize the non-hydrated (dry) octreotide implant in its Phase III program. The octreotide implant employs the same patented Hydron technology utilized in the Company’s currently approved and marketed products SUPPRELIN(R) LA and VANTAS(R).

About Acromegaly

Acromegaly is a chronic hormonal disorder that occurs when a pituitary tumor produces excess growth hormone, or GH. It most commonly affect middle- aged adults, and if untreated, causes enlargement of certain bones, cartilage, muscles, organs and other tissues, leading to serious illness and potential premature death. There are approximately 1,000 new acromegaly patients diagnosed per year and 18,000 total patients in the United States.

About Octreotide Implant

The Indevus octreotide implant is a proprietary formulation of octreotide in a six-month implant utilizing the Company’s patented Hydron technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release of octreotide, a long-acting octapeptide that mimics the natural hormone somatostatin to block release of growth hormone (GH), over a six month period.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company’s approved products include SANCTURA(R) XR and SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company’s core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, octreotide for acromegaly, and pagoclone for stuttering.

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MetaCure Limited, announced that it began patient enrollment in a national diabetes clinical trial of its TANTALUS(R) System, an investigational device being tested in patients with type 2 diabetes who are overweight. The study is being conducted in up to 30 sites in the United States

The 300-patient trial will evaluate the TANTALUS, an implantable device that delivers electrical pulses to the stomach when a person eats. The primary objective of the randomized, double-blind controlled study is to evaluate the TANTALUS System in treating patients who have type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood pressure and other clinical and metabolic parameters will be studied. To be considered for the trial, patients must meet certain inclusion criteria, including a diagnosis of type 2 diabetes with a body mass index (BMI) between 28 and 45 kg/m2 and ages 18 to 70.

“Even with current medications and lifestyle changes, controlling blood glucose levels in type 2 diabetes patients who are overweight can be difficult,” said Naji N. Abumrad, MD, MetaCure’s Medical Director and John L. Sawyers Professor of Surgery and Chairman, Department of Surgery at Vanderbilt University Medical Center, Nashville, TN. “We are excited to have this trial underway as a potential alternative treatment for patients where we have been unsuccessful in managing their type 2 diabetes and weight.”

Glandular Diseases Center of San Antonio, Texas, is the first trial site to enroll patients. “We are delighted to be participating in this trial and to be the initial center to implant the TANTALUS System in study patients,” said Mark Kipnes, MD, of the Glandular Diseases Center.

“The TANTALUS System is currently CE marked and available to patients in Europe for the indication to treat type 2 diabetes with obesity. It has been clinically evaluated in more than 100 patients world wide,” explained Dr. Irit Yaniv, MetaCure’s Chief Operating Officer. “We look forward to potentially being able to make it accessible in the future to U.S. patients as well.”

For more information about the study, please go to http://www.metacure.com.

More About the TANTALUS System

The TANTALUS System includes a pulse generator and leads that are implanted through a minimally invasive laparoscopic procedure that can be performed in an outpatient setting. The leads are implanted in the gastric muscle and the device is implanted in a subcutaneous pocket.

The system is based on new technology called Gastric Contractility Modulation (GCM) that is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation treatment during meal times.

About MetaCure

MetaCure Limited was founded in 2003 and is developing minimally invasive solutions for today’s most pressing global epidemic, type 2 diabetes. Its flagship product, the TANTALUS System, has already been granted the CE mark in Europe. The company’s corporate U.S. offices are based in Orangeburg, New York, and Mt. Laurel, New Jersey. For more information, visit http://www.metacure.com.

MetaCure Limited
http://www.metacure.com

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ScienceDaily (Nov. 28, 2007) — Radiologists are investigating the use of computed tomography (CT) as a tool for civilian medical examiners’ autopsies in the United States. According to findings presented November 27 at the annual meeting of the Radiological Society of North America, CT autopsy has the potential to replace conventional autopsy in determining the cause of certain accidental deaths.
“CT is a sensitive imaging tool for detecting injuries and cause of death in victims of blunt trauma,” said Barry Daly, M.D., professor of radiology at the University of Maryland School of Medicine in Baltimore. “When there are major injuries, such as those resulting from a motor vehicle accident, CT may provide enough information to enable a conventional autopsy to be avoided altogether.”
All states are required by law to perform an autopsy in cases of sudden and unexplained deaths. Of the 8,000 such deaths referred to the chief medical examiner of the state of Maryland last year, approximately one-half required full autopsy.
CT autopsy compares favorably to conventional autopsy in several ways. In cases of suspicious death, the noninvasive procedure does not damage or destroy key forensic evidence, as can happen during a conventional autopsy. In addition, CT can be used in situations where autopsy may be prohibited by religious or cultural beliefs. CT autopsy is considerably less expensive than conventional autopsy and can be performed in a fraction of the time. A forensic medical examiner requires several hours to conduct a full autopsy, while multi-detector CT scanning and interpretation can be completed in about 30 minutes.
In Dr. Daly’s study, 20 autopsies were performed using whole-body multi-detector CT at the University of Maryland Medical Center.
Interpretations of the CT scans by two radiologists were compared with the results of a conventional autopsy performed on each body by state forensic medical examiners. Included were 14 victims of blunt trauma and six victims of a penetrating wound made either by a knife or ballistic weapon.
In all 14 blunt trauma cases and five of the six penetrating wounds, CT accurately identified the cause of death. The radiologists and forensic medical examiners evaluated the CT findings as comparable to conventional autopsy in 13 of the 14 blunt trauma cases and as a helpful adjunct in five of the six penetrating wound cases. In the study, CT was able to localize rapidly all 26 major ballistic fragments recovered from the victims during conventional autopsy.
“Autopsy is mandatory in deaths involving gunshot wounds, but CT can serve as a powerful adjunct to the conventional exam,” Dr. Daly said. “Performing CT imaging first may speed up a conventional autopsy, especially when it comes to locating ballistic fragments, which are so important to criminal investigations.”
In addition, CT was more sensitive than conventional autopsy in identifying air embolism, an often undetected important contributing factor in fatal trauma.
While CT has previously been used in autopsies of American soldiers and in a few countries outside the U.S., the technology is only now generating strong interest within the nation’s forensic community.
“Although these preliminary results are promising, more research is needed to show that CT could be widely used within the U.S. medical examiners system,” Dr. Daly said.
Co-authors are C.W. Sliker, M.D., D. Zulauf, R.N., J.L. Titus, M.D., P.A. Shah, M.D., M. Ripple, M.D., Z. Ali, M.D., and D. Fowler, M.D.
Adapted from materials provided by Radiological Society of North America.

Fausto Intilla
www.oloscience.com