Initial chemotherapy alone after surgery is just as successful as initial radiation therapy for patients from whom a very malignant brain tumor (anaplastic glioma) was removed. With this treatment, the patients survive on average > 30 months without a recurrence. A study conducted by the Neurooncology Working Group of the German Cancer Society led by researchers from Heidelberg and Zürich showed that patients in primary therapy benefit to the same extent from chemotherapy alone as from radiation alone.

In addition, the Working Group headed by Professor Dr. Wolfgang Wick, Medical Director of the Department of Neurooncology at Heidelberg University Hospital and Head of the Neurooncology Unit at the DKFZ, Professor Dr. Michael Weller, Chairman of the Department of Neurology at the University Hospital Zurich, and Prof. Andreas von Deimling, Medical Director of the Department of Neuropathology at Heidelberg University Hospital and Head of the Neuropathology Unit at the DKFZ, identified a new factor that is indicative of a positive prognosis - regardless of the form of treatment. The results of the study were published in the Journal of Clinical Oncology.

In Germany, around 4,500 people a year develop a glioma, a malignant brain tumor. Some 5 percent of primary brain tumors are what are known as anaplastic gliomas. They respond to treatment somewhat better than most other malignant brain tumors. The mean survival time in the study was > 80 months. As the tumors can branch out widely into the surrounding tissue, they cannot be completely removed. The subsequent therapy in the form of combined radiochemotherapy (radiation and chemotherapy) is the current standard treatment, but it is associated with a risk of long-term toxicity to healthy brain tissue, causing the patient to lose cognitive abilities.

Primary chemotherapy as an equivalent treatment option

Two studies recently conducted by the European Organization for Research and Treatment of Cancer (EORTC) and the Radiation Therapy Oncology Group (RTOG) have shown that combined radiochemotherapy according to current standard practice does not yield better therapy results than radiotherapy alone. The NOA (Neurooncology Working Group) study has now also proven that chemotherapy alone after surgical removal of the tumor has an equivalent result. “This additional treatment option facilitates the further development of the treatment plan in new combinations with the long-term goal of improving the survival rate,” says Professor Wolfgang Wick.

Gene mutation predicts improved outcome

Depending on their tissue composition, anaplastic gliomas are classified in different sub-groups which are assumed to have different prognoses. However, in this study, the previously distinct sub-groups of oligodendroglial tumors had an identical clinical course. With the aid of extensive molecular pathology studies of extirpated tumor tissue, the researchers identified a new prognosis factor called IDH1 mutation (gene mutation of isocitrate dehydrogenase). It is indicative, irrespective of the type of tissue of the anaplastic glioma and irrespective of treatment, of a better prognosis. The researchers proved that the already known prognosis factor “MGMT promoter methylation” is not predictive for chemotherapy, but did have prognostic value for chemotherapy as well as for radiation alone. “The results are relevant not only for clinical routine, but for current study designs of the large study networks EORTC and RTOG as well,” explained Professor Wick.

Reference:


NOA-04 Randomized Phase III Trial of Sequential Radiochemotherapy of Anaplastic Glioma With Procarbazine, Lomustine, and Vincristine or Temozolomide. Wolfgang Wick, Christian Hartmann, Corinna Engel, Mandy Stoffels, Jorg Felsberg, Florian Stockhammer, Michael C. Sabel, Susanne Koeppen, Ralf Ketter, Richard Meyermann, Marion Rapp, Christof Meisner, Rolf D. Kortmann, Torsten Pietsch, Otmar D. Wiestler, Ulrike Ernemann, Michael Bamberg, Guido Reifenberger, Andreas von Deimling, and Michael Weller. Journal of Clinical Oncology, in press.

Source:
Prof. Dr. med. Wolfgang Wick

University Hospital Heidelberg

Minnow Medical, Inc., a developer of innovative products to treat artery disease, announced that positive clinical trial results using the Company’s Guided Reshaping Technology (GRT™) to treat peripheral artery disease (PAD) were presented last week at the TCT 2009 Conference in San Francisco.

James R. Margolis M.D., director of research at the Miami International Cardiology Consultants, presented interim data from 78 patients showing 97.5 procedural success rate, improved ?1 Rutherford class at 94%, and that no adjunctive therapies, such as a stent or atherectomy were required. No serious adverse events related to the Minnow Medical device were reported. For those patients where interim 6-month follow-up results are available, the data trend to sustainable improvement.

“The early results with Minnow’s product are encouraging. I am looking forward to seeing additional data for this promising new technology,” said Dr. Margolis. “The Guided Reshaping Technology is fast and easy to use, and may become a valuable option in treating PAD.”

The study, which is being conducted at five sites in Germany, Chile, and Argentina, is a prospective, open-label, non-randomized study assessing the safety and effectiveness of Minnow’s GRT System in symptomatic patients with previously untreated blockages in their popliteal and superficial femoral arteries. The subjects are followed for six months to determine clinical evidence of restenosis. The Company expects to receive complete six-month follow-up data later this year.

Minnow’s GRT System treats arterial disease by precise delivery of controlled, non-ablative radiofrequency (RF) energy to open diseased arteries. The RF energy is delivered through electrodes on the surface of a specially designed disposable angioplasty balloon catheter. Minnow’s catheter received the CE Mark for marketing in the European Union in April 2009.

Source
Minnow Medical, Inc.

Intercept Pharmaceuticals, Inc., has announced that its first-in-class farnesoid X receptor (FXR) agonist INT-747 has met the primary endpoint of improved insulin sensitization in a 6 week double blind, placebo controlled trial in type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD).

By employing a euglycemic insulin clamp procedure, the study demonstrated that a single oral daily dose of INT-747 statistically significantly improved glucose disposal rate, consistent with improved hepatic and peripheral insulin sensitivity. Furthermore, patients treated with INT-747 demonstrated statistically significant weight loss and improved biochemical markers of liver function. The compound was well tolerated at the doses tested, with side effects similar to placebo.

Intercept’s Chief Medical Officer, David Shapiro, MD, commented, “INT-747 therapy generated several clinically meaningful signals in this first proof of concept study, validating the mechanism of action of FXR activation that we and other groups have described preclinically.” Dr. Shapiro is presenting the results of the trial on Friday, Oct. 2, in a plenary session at the European Association for the Study of Diabetes (EASD) annual meeting.

Insulin resistance is an important driver of liver fibrosis, the progressive scarring that can lead to cirrhosis. Based on INT-747’s ability to improve insulin sensitivity and other important parameters of liver function in this patient population, Intercept is planning to initiate a Phase II trial in patients with nonalcoholic steatohepatitis (NASH) in 2010. There are an estimated 5 million or more NASH patients in the United States alone with no effective therapeutics currently available.

About Intercept Pharmaceuticals

Intercept is a clinical stage biopharmaceutical company focused on discovering and developing small molecule drugs for the treatment of chronic fibrotic and metabolic diseases. The company’s most advanced programs are focused on the development of modified bile acids that are selective for FXR, a nuclear receptor, and TGR5, a G protein-coupled receptor. Intercept’s lead drug candidate, the FXR agonist INT-747, is currently being advanced for chronic liver disease indications. The company’s next candidate in the pipeline, INT-777, is a selective TGR5 agonist being advanced to an IND, projected for the second quarter of 2010.

Source: Intercept Pharmaceuticals, Inc

Researchers at Monash University and the United States-based Berman Center for Outcomes and Clinical Research will lead an international clinical trial to test whether taking aspirin contributes to good health in the elderly.

The trial, ASPirin in Reducing Events in the Elderly (ASPREE), has been awarded US$50 million from the National Institute on Aging, part of the National Institutes of Health, the peak health funding body in the United States. This support follows earlier funding of $3.5 million from the National Health and Medical Research Council of Australia.

The study will recruit 12,500 healthy men and women aged 70 years and over in Australia and 6,500 in the US. Half will take daily low-dose aspirin and half a placebo tablet over a period of five years.

Head of the Monash School of Public Health and Preventive Medicine Professor John McNeil, who is the study’s principal investigator in Australia, said the health and wellbeing of older Australians was at the centre of the study.

“We want to look at the potential of aspirin to improve the health of older Australians, something that is increasingly important as the population ages. This age group has not previously been studied in sufficient numbers to inform health guidelines,” Professor McNeil said.

“Doctors know that aspirin should help to prevent heart attacks and some forms of stroke. Research indicates that aspirin may also prevent mental decline and some forms of cancer. However, aspirin is also known to have side effects, such as increased bleeding, that may offset its benefits.”

Professor McNeil said the study follows increasing international debate about the role of aspirin for prevention of disease in healthy individuals. ASPREE will determine if daily consumption of aspirin will help older Australians remain physically active and productively involved with their families and wider communities, as well as have better cognitive and cardiovascular function.

“ASPREE is the largest prevention trial to be undertaken in Australia,” Professor McNeil said. “Its outcome will determine whether health practitioners in Australia and internationally should routinely recommend low-dose aspirin for their older patients.

Professor Mark Nelson, Chair of the Discipline of General Practice, University of Tasmania and a member of the core research group said, “The study is a partnership between researchers, general practitioners and the community. The involvement of general practitioners in Australia is crucial to the success of the study. We will work closely with GPs, initially across Victoria, Tasmania and the ACT and later in other states, to invite the many suitable volunteers who will be needed for the study.”

ASPREE study executive officer Dr Robyn Woods commented, “Because of the power provided by the number and the targeted age range of participants, the results of this trial will offer us more insight than any other study into the benefits of aspirin for older people.”

Professor Richard Grimm is the US project leader at The Berman Center which is a part of the Minneapolis Medical Research Foundation.

Source:
Samantha Blair

Monash University

The University of Florida will receive $29.5 million in federal stimulus funds over the next two years from the National Institute on Aging to begin a six-year study on whether a program of structured physical activity can prevent or delay major movement disability in older adults.

When completed, funding for the project is expected to total more than $60 million from the NIA, including the $29.5 million through the American Recovery and Reinvestment Act of 2009. The total will amount to the largest federal award to UF, as well as fund the largest study to prevent mobility disability in seniors.

Many studies have shown that regular exercise improves physical performance. And the U.S. Department of Health and Human Services recommends that adults engage in at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic activity each week, as well as muscle-strengthening activities.

Still, little is known about whether exercise can actually help prevent major mobility disability, defined as the inability to walk a quarter of a mile, or four blocks.

For older adults, staving off disability could help them maintain their physical independence and enhance the quality of their later years.

“We all know that physical activity is good for our health, but the definitive evidence whether it can prevent disability in older people - whether you can prevent them from being unable to walk - is lacking,” said principal investigator Marco Pahor, M.D., director of the UF Institute on Aging.

The new study, called the Lifestyle Interventions and Independence for Elders, or LIFE study, seeks to fill that gap in scientific knowledge. This phase 3 randomized controlled trial of 1,600 sedentary adults ages 70 to 89 who are at risk of mobility disability will be conducted at eight institutions around the country.

It expands on the results of a pilot study that found the rate of onset of mobility disability was lower among a group of older adults who engaged in a structured exercise program for a year, compared with a group of seniors who took part in a health education program for a year.

“This grant reflects NIH’s recognition of the excellence of Dr. Pahor’s work in this area over the past 10 years,” said David S. Guzick, M.D., Ph.D., UF’s senior vice president for health affairs and president of the UF&Shands Health System. “It represents the kind of translational research that UF will increasingly be in a position to conduct.”

UF is the coordinating center and a field site for the LIFE study, with other field sites at Northwestern University, Pennington Biomedical Research Center - a campus of the Louisiana State University system, Stanford University, Tufts University, the University of Pittsburgh, Wake Forest University Health Sciences and Yale University.

Recruitment will begin in early 2010. Eligible participants will be randomly assigned either to take part in a program of moderate-intensity physical activity or a health education program on successful aging. Individuals will be followed for up to three-and-a-half years.

It will be the largest randomized controlled trial ever conducted on physical activity in older adults, and the size of the study will allow scientists to examine the effect of physical activity on a large number of outcomes in ways that have not been possible before.

Primarily, the study seeks to gauge whether there are long-term effects of physical activity interventions on major mobility disability. Investigators will also examine the effects of physical activity on a number of factors, including cognitive function, serious fall injuries, disability in basic activities of daily living, cardiovascular events and hospitalization and nursing home admission. They will also examine quality-of-life measures such as depression symptoms, sleep quality, stress and satisfaction with life.

In addition, the project will allow an assessment of the cost effectiveness of walking programs for the elderly, and whether the money spent on such programs can help reduce medical expenses for injuries and illness that might otherwise result from lack of adequate physical activity.

As life expectancy increases in the United States, the care of older adults has become a major issue for clinical practice as well as public health policy. Average life expectancy today is 77.7 years - almost seven years more than in 1970, according to CDC data.

As adults age, many lose vitality and the inclination or ability to engage in physical activities as simple as walking. Older adults ages 60 to 85 spend almost 60 percent of their time - more than eight of their waking hours - in sedentary behaviors, according to data from the National Health and Nutrition Examination Survey.

The length of time spent in sedentary behaviors has been associated with increased risk of weight gain and various diseases, including diabetes and heart disease. And people who lose their mobility have higher rates of sickness, hospitalization and death than others who do not have disabilities.

“Limitations in walking ability compromise independence, and contribute to the need for assistive care,” said Evan C. Hadley, M.D., director of NIA’s Division of Geriatrics and Clinical Gerontology, whose program is overseeing the trial. “Older people with impaired walking are less likely to remain in the community, have higher rates of certain diseases and death, and experience a poorer quality of life. A successful intervention might help prevent these bad outcomes.”

Source:
Czerne M. Reid

University of Florida

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has initiated a Phase 1 study of PV-10 for liver melanoma.

The primary objective of the open-label study is to determine the safety and tolerability of a single intralesional injection of PV-10 in patients with cancer of the liver. Additional objectives are to assess the distribution and retention of PV-10 in the injected lesion, tumor response and viability, and plasma pharmacokinetics of PV-10 following intralesional injection. In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort. Dr. Paul Goldfarb, M.D., of Sharp Memorial Hospital in San Diego, will be the Principal Investigator for the study, which is expected to begin enrolling subjects within the next several weeks.

Dr. Craig Dees, PhD, CEO of Provectus said, “Patients with liver cancer currently have very little choice and a terrible prognosis if the cancer cannot be fully removed through surgery, as the disease is usually deadly within months. We hope to demonstrate that PV-10, which has shown excellent selectivity for melanoma, will be a viable therapeutic for liver cancer and cancers metastatic to the liver.”

Malignant lesions in the liver arising from primary hepatocellular carcinoma (HCC) or metastases from a wide range of cancers represent an ongoing treatment challenge for oncologists. HCC is one of the most common malignancies worldwide, and its incidence is rapidly increasing in the United States. The liver is a common site of metastases from solid tumors, particularly those arising in the gastrointestinal tract. Other tumors, such as lung and breast cancer and melanoma, also readily spread to the liver.

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal has an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

Source
Provectus Pharmaceuticals, Inc.

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Inc. (OTCBB: ADXS), the company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in three (3) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection.

The patients had participated in the first human trial of a live Listeria vaccine for the treatment of advanced, recurrent, metastatic cervix cancer in women who have failed prior cytotoxic treatment. Advaxis is tracking the survival of these patients at three (3) month intervals.

These mortality figures substantially exceed the median survival rate established by the National Cancer Institute’s Gynecologic Oncology Group (GOG), which varies between 3.8 and 6.2 months in studies of patients who have failed prior cytotoxic treatment including chemotherapy with various agents (GOG Protocol #127).

Earlier this year, Advaxis published in the medical journal Vaccine the fact that four (4) of thirteen (13) evaluable patients, treated with ADXS11-001, experienced tumor reductions, two (2) patients had their lesions disappear and fifty-three percent (53%) survived more than one (1) year; thus, posting a median survival rate of 347 days. Although this trial was designed to assess safety, not efficacy or survival, three (3) of the thirteen (13) patients or twenty-three percent (23%) evaluable for efficacy are still alive at over 1,000 days, post-dosing with the study drug, as of September 29, 2009.

About the ADXS11-001 Immunotherapy

ADXS11-001 is a therapeutic vaccine, unlike currently marketed prophylactic vaccines, that treats women who have already developed cervical cancer as a result of human papilloma virus (HPV) infection; the most prevalent sexually transmitted disease in the US today.

Earlier this year, the US Food and Drug Administration (FDA) granted Advaxis an IND for a Phase II clinical trial in human papilloma virus- (HPV) caused cervical intraepithelial neoplasia (CIN), which is pre-cancerous and a precursor to cervix cancer. For further information on ADXS11-001, please visit: http://www.advaxis.com/lc.htm.

Source
Advaxis

Jill M. Siegfried, Ph.D., co-director of the University of Pittsburgh Cancer Institute’s (UPCI) Lung and Thoracic Malignancies Program, has received a $1 million grant from the V Foundation for Cancer Research, an organization founded by ESPN and Jim Valvano, former legendary basketball coach of North Carolina State University. The grant will help support the establishment of new clinical trials for lung cancer patients at the University of Pittsburgh Medical Center’s (UPMC) Cancer Centers.

“This award is especially exciting because it supports the translation of our work in the laboratory directly into two separate clinical trials, which we hope will benefit patients,” said Dr. Siegfried. “It is particularly gratifying when the work in the laboratory moves from bench to bedside.”

The first clinical trial is based on Dr. Siegfried’s research, which found that estrogen acts as a proliferation agent in the lung, activating lung cancer development through pathways similar to those in breast cancer. In addition to examining estrogen’s role as a lung cancer proliferation agent, Dr. Siegfried evaluated anti-estrogens to see if they could inhibit the effect of estrogen on lung tumor growth in animal models and determined which are the most effective at blocking the action of estrogen in the lungs.

According to Dr. Siegfried, her research demonstrated that it might be possible to inhibit lung cancer tumor growth in cancers that progress in response to estrogen. “We learned that some very basic, biological functions put women at risk for developing lung cancer. Now we know estrogen plays a role in the growth of some lung cancers and that gives us something to target in the clinical setting.”

This research was supported by the UPCI Specialized Program of Research Excellence (SPORE) in lung cancer, which is led by Dr. Siegfried. Recent results announced by the Women’s Health Initiative in the medical journal The Lancet support Dr. Siegfried’s hypothesis: women in that study who took hormone replacement medications containing estrogen were much more likely to die from lung cancer than those who did not. The Lancet publication cited Dr. Siegfried’s research as an explanation for the findings.

The clinical trial at UPMC will be led by Athanassios (Ethan) Argiris, M.D., professor of medicine at the University of Pittsburgh School of Medicine, and clinical associate director of UPCI’s SPORE in lung cancer. The SPORE is a federal grant awarded by the National Cancer Institute (NCI) to assist researchers in examining innovative detection and treatment strategies designed to improve survival outcomes and quality of life for patients with early to late-stage lung cancer.

According to Dr. Argiris, the phase II trial will study the use of an aromatase inhibitor, a class of drugs designed specifically to counteract estrogen production, in postmenopausal women with advanced non-small cell lung cancer. “We hope that by targeting estrogen we will be able to extend the lives of women with lung cancer. Moreover, we will have an opportunity to understand which women respond best to this treatment by examining the estrogen receptors found in their tumors.”

Additionally, the V Foundation will support a phase I trial translated from previous SPORE-funded research conducted by Olivera Finn, Ph.D., professor and chair of the Department of Immunology at Pitt. Lung cancer patients who enroll in the trial will receive a vaccine based on the protein cyclin B1. Dr. Finn discovered that this protein is inappropriately expressed by many lung tumors and causes a strong immune response. She hopes to boost the ability of the immune system to reject lung cancer by vaccination with portions of the purified cyclin B1 protein.

Lung cancer is the leading cause of cancer death in both men and women worldwide. Non-small cell lung cancer is the most common type of lung cancer and represents about 80 percent of all lung cancer cases. Unfortunately, because symptoms don’t appear in most patients until the disease is advanced, very few patients survive beyond five years.

Source
University of Pittsburgh Cancer Institute

A medication list can provide emergency medical personnel with lifesaving information and help prevent the nearly 1.5 million¹ people harmed by medication related errors every year. But, a recent consumer survey commissioned by the American Pharmacists Association (APhA) and conducted by Harris Interactive revealed that while a large percentage of Americans have an up-to-date list of their prescription medications, only 28 percent of consumers carry the list with them at all times.

Among the people who do not have an up-to-date list, 49 percent said they never thought about it and 36 percent said they have no desire or need to carry the list. Females (31%) are more likely than males (24%) to carry a list. In addition, as consumers age, the likelihood that they carry a list significantly increases.

APhA recommends that people always carry an updated list of their prescription and over-the-counter medications, vitamins and herbal products. The list should include the name and dosages of the medications, as well as what conditions the medications treat and any of the patient’s known allergies.

“One of the most important things consumers can do to take an active role in their health care is carry a current medication list,” said Kristen Binaso pharmacist and APhA national spokesperson. “Until electronic medical records are the standard and can be shared across providers, consumers should be sharing their list with all of their health care providers to minimize the risk of improper dosing, duplicating medications, and harmful drug interactions and side effects.”

Throughout the year, but in particular during American Pharmacists Month in October, APhA is urging consumers to get to know their pharmacist through its “Know Your MEDICINE, Know Your PHARMACIST” public education campaign. The campaign underscores the link between knowing your pharmacist and the safe and effective use of medications. Improper medication use has been estimated to cost our nation $177 billion² annually in total direct and indirect healthcare costs.

The survey also found that although pharmacists are the medication experts, 77 percent of consumers do not know their pharmacists name and only 40 percent have asked their pharmacist questions about their health care needs in the past year. These statistics are troubling to pharmacists given that they are the most accessible health care providers to the public. While a large percentage of consumers do not know the name of their pharmacist, they still rank pharmacists as the second most trusted source of medication information behind doctors.

“Pharmacists are consumers’ ally in helping them make the best use of their medications,” said Binaso. “We have years of advanced training about how medications can work to improve health and how to help consumers use medications correctly and we are eager to become more involved with our patients’ health.”

To maximize the benefits from medications and minimize the potential for harmful drug interactions and side effects, APhA recommends that consumers ask these questions before taking any type of medication- particularly those who take multiple medications, dietary supplements and/or OTC medications.

- When and how you should I take my medication?
- What should I do if I miss a dose?
- Are there any potential side effects?
- Will my medication(s) interact with other medications or food?
- How do I safely dispose of unused medications?

Other highlights in the survey include:

- Those who know their pharmacists name are more likely to have an up-to-date medication list.
- Two-thirds of consumers accept their pharmacist’s recommendations of OTC products at least most of the time.
- Sixty percent of respondents use one pharmacy to fill prescriptions.
- Fifty-two percent of respondents are likely to ask their pharmacist a question when they receive a prescription for the first time

To download a medication list or to find tips on how to talk to your pharmacist and use medicines safely, visit http://www.pharmacist.com/APhM.

About the 2009 Know Your Medicine; Know Your Pharmacist Survey
The “2009 Know Your Medicine; Know Your Pharmacist” survey was commissioned by the American Pharmacists Association and conducted in May 2009 by Harris Interactive.

Survey Objective: To collect and report information about how consumers interact with and perceive their pharmacist and how their relationship with the pharmacist impacts their use of medications.

Survey Sample: 1,003 qualified respondents from a nationally representative panel. The survey included a similar percentage of men and women and included respondents age 21 and over.

Statistical Confidence: plus/minus 3 percent.

Source
American Pharmacists Association (APhA)

KYTHERA Biopharmaceuticals, Inc. (KYTHERA) presented detailed results from two double-blind Phase 2 studies, each designed to evaluate the safety and effectiveness of ATX-101, a first-in-class injectable drug for the reduction of small volumes of fat. Top-line results from these studies, which examined use of ATX-101 for reduction of unwanted localized fat deposits under the chin (submental fat), were announced in January 2009 (http://www.kytherabiopharma.com/press_releases.html).

Kevin C. Smith MD, FAAD, FRCPC presented study results in Scientific Session at the American Society for Dermatologic Surgery (ASDS) and American Society of Cosmetic Dermatology and Aesthetic Surgery (ASCDAS) Joint Annual Meeting. A recap of the data presentation will be available online at http://www.kytherabiopharma.com/investors.html for seven days.

“ATX-101 shows promise for patients who are seeking a minimally invasive treatment for unwanted localized submental fat,” said Kevin C. Smith, a Canadian investigator in both Phase 2 studies. “The significant reduction we saw in submental fat for patients treated with ATX-101 illustrates its potential as a safe, simple prescription aesthetic product.”

In total, one hundred fifty-seven subjects were randomized in two double-blind, placebo-controlled, dose-ranging studies conducted across 10 centers in the United Kingdom, Canada and Australia. Across these studies, subjects received one of five dosing regimens of ATX-101 or placebo; one dosing regimen was duplicated between studies.

In each study analyzed independently, two of the three dosing regimens tested yielded a statistically significant reduction of unwanted submental fat compared to placebo as measured by physician assessment (ATX-101-06-03 both p<0.05, and ATX-101-07-07 both p<0.01). Submental fat was evaluated at baseline and week 16, using a 5-point Submental Fat Rating Scale.

Similarly, subject self-assessment indicates that treatment with ATX-101 yielded statistically significant improvement in three of three (ATX-101-06-03, all p<0.05) and two of three (ATX-101-07-07, both p<0.01) dosing regimens versus placebo. Subjects were asked to rate appearance at baseline and week 16, using a 7-point Subject Satisfaction Rating Scale.

As presented at the ASDS Meeting, the five active dosing regimens tested were collapsed into three overall dose groups (1, 2 and 4 mg/cm2). Treatment with ATX-101 resulted in statistically significant results on both physician and subject assessments versus placebo (baseline to week 16) in all dose groups (p<0.05).

“We’re very pleased with the outcome of these robust trials. The safety profile and the statistically significant efficacy in patients receiving ATX-101 strongly support expansion of our product development efforts,” said Patricia Walker, MD, PhD, KYTHERA’s Chief Medical Officer.

In both studies, ATX-101 was well tolerated. The most common adverse events were mild pain, swelling, numbing at the injection site, bruising, and induration. These adverse events were limited to the injection site, and most were temporally associated with treatment and resolved within the treatment interval of 28 days. No systemic adverse events were reported.

In long-term follow-up (63 weeks post baseline), the reduction in submental fat for ATX-101-treated patients was sustained.

About ATX-101

ATX-101 is a first-in-class injectable drug being studied for the reduction of small volumes of fat. It is based on an endogenous compound with unique features including selectivity for adipocytes and rapid clearance. ATX-101 clinical research is focused on reducing localized fat deposits, including submental fat. KYTHERA has completed two randomized, double-blind, placebo-controlled, Phase 2 studies with ATX-101 in the reduction of submental fat and two Phase 1 studies: pharmacokinetic and histology.

About Submental Fat (SMF)

Submental fat is a localized subcutaneous fat deposit located immediately beneath the chin and jawline. In the rapidly growing market of minimally-invasive, non-surgical facial rejuvenation, the reduction of facial fat deposits to restore and reshape the jawline remains one of the largest unmet patient needs. According to a recent national, multi-center, clinical evaluation of more than 220 BOTOX® and dermal filler patients, 79% of patients had a measurable excess of submental fat. Currently, there are no FDA approved drugs to reduce excess localized fat.

Source
KYTHERA Biopharmaceuticals

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