Nationally-Recognized Pancreatic Cancer Surgeon Develops Unique Team Approach To Improve Patient Outcomes
Patrick Swayze’s interview regarding pancreatic cancer will air on a Barbara Walters special on January 7. It is the first time he is discussing his Stage 4 diagnosis and battle with the disease.
By the time pancreatic cancer is discovered, it is often late stage and survival rates are low. Dr. Aaron Chevinsky, a surgical oncologist specializing in pancreatic, liver and gastrointestinal (GI) cancers in Morristown, New Jersey, wasn’t satisfied with that reality and has created a groundbreaking team approach to improve communication among specialists and improve outcomes for patients. While this team approach isn’t new, the execution is; multidisciplinary panels are often more focused on policy than diagnoses and treatment specifics.
Dr. Chevinsky is a surgical oncologist specializing in pancreatic, liver and gastrointestinal (GI) cancers at Allied Surgical Group in Morristown, N.J.; chief of surgical oncology at the Carol G. Simon Cancer Center at Morristown Memorial Hospital; and clinical professor of surgery at UMDNJ in Newark, N.J. In October 2008, Dr. Chevinsky was recognized for his groundbreaking work in the multidisciplinary approach to cancer treatment by the American College of Surgeons Cancer Liaison Physicians.
Dr. William L. Diehl and Dr. Mitchel S. Carter from Allied Surgical Group also serve on the multidisciplinary team with Dr. Chevinsky.
The American Cancer Society predicted that, in 2008, about 37,680 people in the United States would be found to have pancreatic cancer and about 34,290 would die of the disease (http://www.cancer.org).
Dr. Chevinsky is available to discuss all aspects of pancreatic cancer diagnosis and treatment, including the implentation of his team approach. A patient (65-year-old former nurse) who was uniquely and successfully treated for pancreatic cancer by Dr. Chevinsky’s multidisciplinary team is also available for media interviews.
About Allied Surgical Group
Allied Surgical Group includes world-class surgeons who have provided state-of-the-art surgery to patients and New Jersey’s finest doctors for more than three decades. Allied Surgical Group’s eight board-certified surgeons include Mitchel S. Carter, M.D., FACS; Aaron Chevinsky, M.D., FACS; William L. Diehl, M.D., FACS; Carey Dolgin, M.D., FACS; Leah S. Gendler, M.D., FACS; Edward R. McLean Jr., M.D., FACS; Michael David Most, M.D.; and David S. Ward, M.D., FACS.
Areas of expertise include oncology; vascular, advanced laparoscopic and obesity surgery; and minimally invasive surgery. Together, the doctors care with compassion and integrity for patients throughout the tri-state region. Allied Surgical Group is located at 261 James St., Suite 2G, Morristown, N.J., and in the Carol G. Simon Cancer Center at Morristown Memorial Hospital. For more information, call 973-267-6400 or visit http://www.alliedsurgical.org.
Allied Surgical Group
Hormone Therapy Linked To Faster Brain Shrinkage In Older Women
US researchers found that hormone replacement therapies (HRT) commonly prescribed to treat symptoms of menopause were linked to
slightly faster loss of brain tissue in areas important for thinking and memory in women aged 65 and over. However, it is possible that any links with
increased risk of dementia were only relevant to those women who were already experiencing symptoms when they started on HRT said the
researchers.
The research comes from two studies reporting findings from a substudy of the National Institutes of Health’s (NIH’s) landmark Women’s Health Initiative (WHI) hormone
therapy clinical trials called the Women’s Health Initiative Memory Study and that appear as companion papers in the 13 January issue of
Neurology.
Previous research showed that HRT comprising conjugated equine estrogens (CEEs, used extensively in HRT), with or without progestin, made it
more likely that older women on these treatments would have more difficulty with thinking and memory, and experience cognitive impairment or
dementia.
These drugs also increase the risk of stroke, so it was assumed that the impact on thinking and memory came from brain lesions due to loss of blood
flow that occurs with strokes, including the “silent” strokes. However, these studies showed that the number of brain lesions were not significantly
higher among women on HRT, but the volume of brain tissue in those parts of the brain that are important for thinking and memory were shrinking
faster than normal in women on HRT.
In the first study, lead investigator Dr Laura Coker of Wake Forest University Baptist Medical Center, and colleagues found that HRT was not linked
to an increase in silent strokes or small vascular lesions in the brain.
In the second study, lead author Dr Susan Resnick, of the NIH’s National Institute on Aging, and colleagues found that women who took HRT had
slightly smaller volumes of brain tissue in two areas that are important for thinking and memory: the frontal lobe and the hippocampus. A shrinking
hippocampus is also thought to be a risk factor for dementia.
For the first study, Coker said they asked themselves what was likely to be the mechanism that linked HRT and the negative impact on thinking and
memory.
“We thought it was silent cerebrovascular disease,” said Coker in a press statement.
“So we designed a study to obtain MRI scans of women’s brains to look for increased volumes of brain lesions among those participants who had
taken hormone therapy, compared to those who had not,” added Coker, who said they were surprised when they did not get the result they expected:
there was no link between HRT and brain lesion increase.
She and her team examined over 1,400 women aged from 71 to 89 who had been taking part in the WHI hormone therapy studies for an average of
four to six years.
For the second study, Resnick and colleagues studied data on the same WHI women that Coker and her team examined. They suggest one explanation
for the increased risk of dementia in older women who had been on HRT in the WHI study was the possibility that the HRT had a “negative effect on
brain structures important in maintaining normal memory functioning”.
But Resnick added that the negative effect was much higher in women who may already have been experiencing problems with thinking and memory
before they started on HRT, suggesting that the hormone therapy may have accelerated a disease that had already started rather than kicked it
off.
Doctors are advised to prescribe HRT only if needed to treat symptoms of the menopause,
and patients should take the lowest dose for the shortest
time needed to gain relief. Symptoms of menopause usually affect women between the ages of 48 and 55, and it is not recommended to treat women
over 65 with HRT because the benefits aren’t worth the risks.
The findings of Resnick and her colleagues suggest that older women who are already experiencing problems with thinking and memory when they
start HRT are the ones who are most at risk in terms of potential effect on the brain and cognitive skills. But, their findings also suggest that women
who aren’t experiencing such difficulties before they start HRT are also less likely to experience adverse effects on their brains.
In the next stage of their investigations, the researchers will be looking at whether the effect on brain volume continues during follow up, and they will
also be looking at younger women who took HRT nearer the menopause to see if they show the same or different pattern of effects on thinking,
memory and brain structure, said Coker.
The WHI is a 15-year program of studies looking at causes of death, disability and poor quality of life in postmenopausal women. The program is
funded by grants from the National Heart, Lung, and Blood Institute of the NIH. The sub-study on memory is also supported by Wyeth
Pharmaceuticals, Inc.
As well as Wake Forest, 15 other universities are involved. The whole WHI program comprises a total participant base of over 161,000 women aged
from 50 to 79 at 40 clinical centers throughout the US, and is thought to be the largest clinical trial ever to take place in the US.
“Postmenopausal hormone therapy and subclinical cerebrovascular disease: The WHIMS-MRI Study.”
L. H. Coker, P. E. Hogan, N. R. Bryan, L. H. Kuller, K. L. Margolis, K. Bettermann, R. B. Wallace, Z. Lao, R. Freeman, M. L. Stefanick, S. A.
Shumaker For the Women’s Health Initiative Memory Study.
Neurology January 13 2009, Volume 72, Issue 2, pp 125-134.
Click here for Abstract.
“Postmenopausal hormone therapy and regional brain volumes: The WHIMS-MRI Study.”
S. M. Resnick, M. A. Espeland, S. A. Jaramillo, C. Hirsch, M. L. Stefanick, A. M. Murray, J. Ockene, C. Davatzikos For the Women’s Health Initiative
Memory Study.
Neurology January 13 2009, Volume 72, Issue 2, pp 135-142.
Click here for Abstract.
Sources: Wake Forest University Baptist Medical Center, journal abstract.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial Of Novel Analgesic In Acute Post-Operative Pain
Cara Therapeutics, Inc. announced that it is initiating a Phase II clinical trial of its long-acting peripheral kappa opioid agonist, CR845. The Phase II multi-center, double-blind, placebo-controlled trial will be conducted in the United States and will evaluate the analgesic efficacy and safety of intravenous CR845 during the post-operative period in women following laparoscopic-assisted hysterectomy. The trial is expected to enroll 120 patients, who will be randomly selected for treatment with one of two doses of CR845 or placebo. Results from the study are expected in the second half of 2009.
The Company also expects to initiate a Phase I study of an oral formulation of CR845 later in 2009.
About CR845
A previous Phase Ia single-center clinical trial of intravenous CR845 evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of the compound in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity. Linear, dose-proportional increases in systemic exposure to CR845 were observed. Low doses of CR845 stimulated physiological biomarkers of peripheral kappa opioid receptor activity, and also produced plasma levels of drug associated with analgesic efficacy in multiple preclinical studies.
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in treating pain of inflammatory, neuropathic and visceral origin and exhibited analgesic efficacy for up to 18 hours after a single dose. Analgesic activity was seen after intravenous, subcutaneous, or oral administration. Oral bioavailability was confirmed in multiple species. In contrast to currently marketed opioids, CR845 did not produce inhibition of intestinal transit (ileus) or elicit signs of abuse or addiction liability in animal models. Preclinical studies also indicate that CR845 possesses anti-itch activity.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.
Forward Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara’s research and clinical studies and Cara’s ability to obtain additional financing. These forward-looking statements represent Cara’s judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
Cara Therapeutics, Inc.
http://www.caratherapeutics.com
MAP Pharmaceuticals Provides Update On Progress Of Two Phase 3 Clinical Programs
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced continued progress with its two Phase 3 clinical programs, Unit Dose Budesonide (UDB) for children with asthma and MAP0004 for the acute treatment of migraine. For UDB, all patients have completed the 12 week treatment period in the initial Phase 3 clinical trial, and for MAP0004, the company currently expects to complete enrollment in its initial Phase 3 clinical trial by the end of January 2009.
“We continue to make good progress with our Phase 3 asthma and migraine programs and look forward to reporting data from both programs during the first half of 2009,” said Timothy S. Nelson, President and CEO of MAP Pharmaceuticals. “We believe this clinical progress coupled with our recently announced asthma partnership with AstraZeneca highlights the value of our clinical approach and business strategy.”
UDB Phase 3 Program
The initial UDB Phase 3 clinical trial completed enrollment in September 2008, and all patients now have completed the treatment period. This Phase 3 trial is a multi-center, randomized, double-blind, placebo controlled trial in approximately 360 children who suffer from asthma, from 12 months to 8 years of age. Patients received either 0.25mg UDB, 0.135mg UDB or placebo twice a day over a 12 week treatment period. The co-primary efficacy endpoints for the study are the change in nighttime and daytime composite symptom scores (cough, wheeze and breathlessness). Patients enrolled in this trial will continue to be followed in a long-term safety trial.
UDB is being studied as a novel version of nebulized budesonide. Budesonide has been used clinically for more than 20 years. UDB is designed to be nebulized more quickly and at a lower nominal dose than the commercially available product. The safety data generated to date has shown UDB to be well tolerated with no significant adverse events reported.
MAP0004 Phase 3 Program
MAP Pharmaceuticals expects to complete enrollment in its initial Phase 3 clinical trial for the acute treatment of migraine by the end of January 2009. The Phase 3 multi-center, randomized, double-blind, placebo controlled trial in approximately 850 migraine sufferers is evaluating MAP0004 as a potential acute treatment for migraine. Patients enrolled in the trial will be evaluated for the treatment of a single migraine and will continue to be followed in a long-term safety trial. MAP Pharmaceuticals is conducting this first Phase 3 trial and the long-term safety trial pursuant to a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration.
MAP0004 is a novel, orally inhaled migraine medication in development which has a multi-targeted mechanism of action, utilizes the company’s proprietary TEMPO(R) inhaler and is designed to optimize the key characteristics of dihydroergotamine, an active ingredient which has been used to effectively and safely treat migraine for over 60 years. MAP0004 has the potential to provide a faster onset of action than currently available migraine treatments, with sustained pain relief and pain freedom, in an easy- to-use, non-invasive, at-home therapy. In a Phase 2 clinical trial, patients reported pain relief in as fast as 10 minutes with sustained relief to 48 hours. The safety data generated to date have shown MAP0004 to be well tolerated with no significant adverse events reported.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals is dedicated to developing and commercializing new therapies for children and adults suffering from chronic conditions that are not adequately treated by currently available medicines. The company has two product candidates in Phase 3 clinical trials. Unit Dose Budesonide is being developed for the potential treatment of asthma in children, and MAP0004 is being developed for the potential treatment of migraine. MAP Pharmaceuticals generates new pipeline opportunities by applying its proprietary drug particle and inhalation technologies to enhance the therapeutic benefits of proven drugs, while minimizing risk, by capitalizing on their known safety, efficacy and history.
Forward Looking Statements
In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to MAP Pharmaceuticals’ late stage clinical programs. Actual results may differ materially from current expectations based on risks and uncertainties affecting MAP Pharmaceuticals’ business, including, without limitation, risks and uncertainties relating to the failure to obtain clearance of the collaboration agreement with AstraZeneca under the Hart-Scott-Rodino Act, the enrollment, conduct, completion and reporting of clinical trials, as well as risks related to the failure to achieve favorable clinical outcomes or to have the company’s product candidates approved for commercial use by the U.S. Food and Drug Administration. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q, filed with the SEC on November 13, 2008, and available at http://edgar.sec.gov.
MAP Pharmaceuticals, Inc.
http://www.mappharma.com
Sunesis Pharmaceuticals Provides Year-End Clinical Update On Voreloxin
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) provided a clinical update on voreloxin, its novel investigational drug candidate currently being developed in Phase 2 trials for acute myeloid leukemia (AML) and ovarian cancer. The clinical update coincides with the company’s attendance at the 27th Annual JP Morgan Healthcare Conference in San Francisco.
“2008 was an important year for Sunesis, as we have continued to advance the development of voreloxin in both AML and ovarian cancer. We believe voreloxin has the potential to be a first-in-class anti-cancer agent for treating these diseases and potentially other hematologic and solid tumors,” said Daniel Swisher, Chief Executive Officer and President of Sunesis. “We completed enrollment of our Phase 2 platinum-resistant ovarian cancer study and both of our ongoing AML studies are enrolling well, with 45 AML patients enrolled in the fourth quarter of 2008 alone. In the first half of 2009, we anticipate reporting additional data from all three of our ongoing voreloxin studies. We remain on track to initiate a pivotal voreloxin study in AML by the end of this year.”
Sunesis is providing an update on the progress of its voreloxin clinical trials as follows:
Phase 2 and 1b/2 Studies of Voreloxin in AML
Sunesis is evaluating single agent voreloxin in an ongoing Phase 2 trial, known as REVEAL-1, in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy. Interim results recently presented at the 50th Annual Meeting of the American Society of Hematology (ASH) show that voreloxin induces complete remissions in these poor risk patients. At ASH, outcome for the 29 patients enrolled and treated with Schedule A, 72 mg/m2 of voreloxin weekly for three weeks, was reported. Eleven patients achieved a complete remission (CR) or complete remission without full platelet recovery (CRp), for an overall remission rate of 38 percent. The 30-day all-cause mortality rate was 17 percent, which compares favorably to standard induction chemotherapy. Data on the median duration of response for patients achieving a CR or CRp in Schedule A is not yet available.
With Schedule B, 72 mg/m2 of voreloxin weekly for two weeks, Sunesis is exploring if the therapeutic index is improved by eliminating the third dose. Early data suggest that Schedule B is better tolerated by patients, while maintaining anti-leukemic activity. New data on the 21 patients on Schedule B reported on at ASH indicate 6 have achieved a CR or CRp, while 2 are awaiting hematologic count recovery. In addition to improved tolerability, the 30-day all-cause mortality rate has been reduced to 5 percent (1 of 21).
Additionally, the company is rapidly accruing relapsed or refractory AML patients in a Phase 1b/2 clinical trial testing voreloxin in combination with cytarabine given by continuous infusion (Schedule A) or by 2 hr IV infusion (Schedule B). At ASH, Sunesis reported that a maximum tolerated dose (MTD) of 80 mg/m2 was established for Schedule A, with 9 CRs or CRps reported in the Phase 1b dose escalation. The Phase 2 portion of this study has now enrolled eight patients with AML in first relapse at the Schedule A MTD and complete remissions have been observed. In addition, Schedule B has completed safety assessment for the first cohort without dose limiting toxicities, and the second cohort is now enrolling at 80 mg/m2 of voreloxin.
“We are extremely pleased by these interim results for both of our AML studies. In the REVEAL-1 study, overall tolerability has improved with the amended dose regimen, while maintaining activity,” said Steve Ketchum, Senior Vice President, Research and Development for Sunesis. “Our combination study has shown complete remissions and a manageable safety profile. Both studies are continuing to enroll well, and, pending final clinical data, allow us to explore potential registration strategies in either newly diagnosed or first relapse AML populations.”
Phase 2 Trial of Voreloxin in Platinum-Resistant Ovarian Cancer
Enrollment is complete for the Phase 2 study of voreloxin in platinum-resistant ovarian cancer. Three schedules of voreloxin have been studied, 48 mg/m2 given every three weeks (N=65), and 60 mg/m2 (N=37) and 75 mg/m2 (N=35) given every four weeks. As reported at the 12th Biennial Meeting International Gynecologic Cancer Society, two complete responses and five partial responses were observed at 48 mg/m2. Thirty patients (46%) achieved disease control, defined as stable disease for 90 days or more or a complete or partial response. Median progression free survival is 82 days. All patients at this dose level are now off-study. Data are maturing for both the 60 and 75 mg/m2 cohorts. One complete response and three partial responses of thirty-four patients for whom data are available are reported thus far at 60 mg/m2; nine patients remain on study. Early response data on ten patients at 75 mg/m2 show one partial response to date and five patients with stable disease; twenty patients remain on study. Voreloxin was generally well-tolerated at 48 and 60 mg/m2, with an incidence of febrile neutropenia of below 10%. An increase in febrile neutropenia is observed at 75 mg/m2, although the incidence remains below 20%.
About Voreloxin
Voreloxin is a novel naphthyridine analog, structurally related to quinolones, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, irreversible G2 arrest and apoptosis. Voreloxin is currently being evaluated in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML as well as in an ongoing Phase 2 single-agent trial in platinum-resistant ovarian cancer.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The Leukemia and Lymphoma Society estimates that over 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. during 2007. AML is generally a disease of older adults and the median age of a patient diagnosed with AML is about 67 years. A majority of elderly patients are not considered candidates for standard induction therapy or decline therapy, resulting in an acute need for new treatment options.
About Ovarian Cancer
In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2008 there will be an estimated 21,650 new cases and more than 15,000 deaths from ovarian cancer in the U.S. alone. Following frontline treatment, recurrence rates among ovarian cancer patients are high. Treatment options remain limited following relapse and overall long-term survival has not changed significantly over the past 40 years, with five-year survival rates at less than 30 percent.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. Enrollment and dose escalation is completed in a Phase 1 study of a second product candidate, SNS-314, in patients with advanced solid tumors. An MTD was not established and no responses have been observed. Sunesis is seeking to partner or license SNS-314 for further development. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
This press release contains forward-looking statements including without limitation statements related to the potential safety, efficacy and commercial potential of voreloxin; planned additional clinical testing and development efforts for voreloxin; and the timing of enrollment in the ongoing clinical trials of voreloxin. Words such as “anticipate,” “remain on track, “”indicate,” “suggest,” “appears,” “encouraging,” “interim,” “potential,” “estimates,” “believe” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis’ current expectations. Forward-looking statements involve risks and uncertainties. Sunesis’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Sunesis’ need for additional funding, the risk that Sunesis’ development activities for voreloxin, including enrollment and reporting of results, could be halted significantly or delayed for various reasons; the risk that Sunesis’ clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval; the risk that preliminary data and trends may not be predictive of future data or results; the risk that Sunesis’ preclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies; and risks related to the conduct of Sunesis’ clinical trials and manufacturing. These and other risk factors are discussed under “Risk Factors” and elsewhere in Sunesis’ Annual Report on Form 10-K for the year ended December 31, 2007, Sunesis’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Sunesis Pharmaceuticals, Inc.
http://www.sunesis.com
Anthera Completes Enrollment And Dosing Of Varespladib Cardiovascular Trial
Anthera Pharmaceuticals, Inc., a privately held biopharmaceutical company developing anti-inflammatory drugs, announced that it has completed enrollment in its 500 patient FRANCIS (Fewer Recurrent Acute coronary events with Near-term Cardiovascular Inflammation Suppression) clinical trial designed to examine the impact of varespladib (A-002) when administered to patients within 96 hours of an Acute Coronary Syndrome (ACS) event.
“We are pleased with the continued progress of our varespladib cardiovascular program targeting secretory phospholipase A2,” said Paul Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. “The multiple therapeutic impact of varespladib’s mechanism of action provides us with a unique opportunity to develop a first-in-class product targeting a life-threatening coronary event for which there are limited therapeutic options.”
“With the varespladib trial fully enrolled, we look forward to reporting the biomarker results and event trends later this year,” said Colin Hislop, M.D., Senior Vice President of Clinical Development at Anthera Pharmaceuticals, Inc. “Based upon the positive results from varespladib’s two previous Phase II clinical trials that demonstrated lipid-lowering and anti- inflammatory benefits, we look forward to examining the impact of varespladib on the hyper-inflammatory state presented by ACS patients.”
Anthera’s FRANCIS trial is based upon direct feedback from FDA via the Special Protocol Assessment procedure. The trial is designed to assess the impact of oral varespladib on known biological markers of cardiovascular risk. Anthera plans to enroll between 500-700 patients that will be treated for up to six months. The study is being conducted at sites across North America and Europe. The FRANCIS trial is expected to provide further insight into the prevention of secondary Major Adverse Cardiovascular Events (MACE) over the duration of the trial. In this study, MACE is defined as a composite endpoint consisting of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a subset of revascularization following the initial event. During the course of the study, patients will receive therapeutic standard of care in addition to high dose Lipitor(R) (atorvastatin). In previous clinical trials, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated marked improvements in independent markers of cardiovascular risk including a near complete suppression of the target enzyme sPLA2, a clinically meaningful and statistically significant reduction in “bad” LDL cholesterol, and a reduction in C-reactive protein, a known marker of inflammation.
About Acute Coronary Syndrome
Acute coronary syndrome is a heart condition characterized by chest pain occurring at rest or upon minimal exertion. This condition is also referred to as unstable angina. If the chest pain is associated with heart muscle damage and heart tracing abnormalities, it is typically classified as a heart attack or myocardial infarction.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a privately held company committed to developing and commercializing clinical pharmaceutical products that address unmet medical needs of patients with life-threatening, chronic and acute inflammatory diseases and autoimmune disorders. The Company has acquired from Eli Lilly and Company and Shionogi & Co. Ltd. worldwide rights (excluding Japan) to a series of clinical and pre-clinical compounds that inhibit the enzymatic activity of members of the phospholipase (PLA2) family – a group of enzymes responsible for the release of arachidonic acid and subsequent production of leukotrienes prostacyclins and other mediators of inflammation. These highly potent compounds inhibit novel upstream steps in the inflammation cascade and have the potential to address a variety of diseases. The company has also acquired exclusive and worldwide rights to a peptide fusion protein, A-623, for the treatment of autoimmune diseases from Amgen. For more information, please visit http://www.anthera.com.
Anthera Pharmaceuticals, Inc.
http://www.anthera.com
Human Genome Sciences Announces Initiation Of Phase 2b Trial Of Albuferon(R) Dosed Monthly In Chronic Hepatitis C
Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that Novartis has initiated dosing in a Phase 2b trial that will evaluate the safety and efficacy of Albuferon(R) (albinterferon alfa-2b) administered monthly in combination with ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
“Patients undergoing treatment for chronic hepatitis C often find it challenging to participate in normal daily activities, especially in the days following dose administration,” said Stephen Pianko, M.D., F.R.A.C.P., Ph.D., Monash University, Melbourne, Australia. “Pegylated interferons, the current standard of care, require administration once every week. Albinterferon alfa-2b dosed every four weeks with a total of six injections could offer an important treatment option, if it demonstrates comparable safety and efficacy vs. peginterferon alfa-2a dosed weekly with a total of 24 injections.”
In December 2008, HGS announced that Albuferon met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon in combination with ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. In these patients, the Phase 3 study showed that 900-mcg Albuferon administered every two weeks had efficacy comparable to peginterferon alfa-2a, with comparable rates of severe and/or serious adverse events and discontinuations due to adverse events.
“Hepatitis C is the most common chronic blood-borne infection in the developed world, and there continues to be a significant need for more effective and better tolerated treatments,” said Mani Subramanian, M.D., Ph.D., Executive Director, Clinical Research – Infectious Diseases, HGS. “Only an estimated 40% of U.S. patients diagnosed with chronic hepatitis C have undertaken treatment to date – in part due to the side effects associated with interferon injections, which are currently required on a weekly basis. A monthly dosing schedule with Albuferon may well result in more patients choosing to be treated.”
About the Design of the Phase 2b Monthly Dosing Trial
This Phase 2b trial is a randomized, open-label, multi-center, active-controlled, adaptive-design dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every four weeks plus daily ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Approximately 375 patients will be randomized in a 4:4:4:3 ratio into four treatment groups, including three that will receive albinterferon alfa-2b administered once every four weeks (900 mcg, 1200 mcg or 1500 mcg), in addition to the active-control group, which will receive peginterferon alfa-2a at the standard 180-mcg dose once every week. All patients in the study will receive 800-mg daily oral ribavirin. The total duration of treatment will be 24 weeks. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).
About Albinterferon Alfa-2b (Albuferon)
Albinterferon alfa-2b is a novel, longer-acting form of interferon alfa that was created using the proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 19 days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins. Albuferon results from the genetic fusion of human albumin and interferon alfa.
Albuferon is being developed by HGS and Novartis for the treatment of chronic hepatitis C under an exclusive worldwide co-development and commercialization agreement entered into in June 2006. HGS and Novartis will co-commercialize Albuferon in the United States and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $132.5 million received to date.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. When detectable levels of HCV persist in the blood for at least six months, a person is diagnosed with chronic hepatitis C. Hepatitis C virus can cause serious liver disease, leading to cirrhosis, primary liver cancer and even death.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. The Company’s primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon(R) (albinterferon alfa-2b) for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both drugs are ongoing. ABthrax(TM) (raxibacumab) is in late-stage development for inhalation anthrax, and the Company is awaiting authorization to begin delivery of ABthrax to the U.S. Strategic National Stockpile. HGS also has three drugs in clinical development for the treatment of cancer, including two TRAIL receptor antibodies and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, which GSK has advanced to Phase 3 development as a potential treatment for coronary heart disease.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Human Genome Sciences, Inc.
http://www.hgsi.com
Solace Pharmaceuticals Initiates Phase IIa Trial Of Glial Cell Modulator SLC022 In Post-Herpetic Neuralgia
Solace Pharmaceuticals, a private biotechnology company discovering and developing innovative treatments for pain, announced the initiation of a proof-of-concept clinical trial of SLC022 in patients with post-herpetic neuralgia (PHN). PHN, a painful complication of shingles, affects approximately 200,000 people a year in the US alone. The clinical trial is an international, multi-center, placebo-controlled study that will examine the effectiveness of SLC022 in controlling pain associated with PHN. Solace anticipates having results from the study in the second half of 2009.
SLC022 is an orally administered glial cell modulator that has shown efficacy in well-established preclinical pain models. Glial cells represent an important new target for the treatment of chronic pain based on their active role in neuronal pain signaling.
“The initiation of this study is another important milestone for Solace in our drive to discover and develop innovative treatments for pain,” said Dr. Eliot Forster, Solace’s Chief Executive Officer. “Our confidence in SLC022 is underpinned by a large body of prior preclinical and clinical data generated during the compound’s previous development in a non-pain indication. We believe these data lower the development risk and enhance the opportunity for a favorable clinical profile.”
Solace’s advancement of SLC022 caps a year of significant progress. In 2008, Solace expanded its glial cell modulator program by identifying next-generation, novel leads with attractive drug properties. The company made equally rapid progress in optimizing inhibitors of the enzyme GTP cyclohydrolase 1 (GCH1), a key target within the BH4 synthesis pathway, and in identifying additional promising drug targets.
Solace Pharmaceuticals also established a two-year collaboration with Professor Keith Channon, MD FRCP, of the Department of Cardiovascular Medicine at the University of Oxford, UK. Professor Channon is a world-leading expert in the biochemistry of the BH4 pathway and the vascular endothelial system. Dr. Channon’s work complements Solace’s work in the development of small-molecule inhibitors of the BH4 pathway for treating chronic pain.
“We believe that the collaboration between Professor Channon and Solace will significantly augment the understanding of GCH1 and help advance development of promising therapeutic compounds,” said Dr. Al Naylor, Solace’s Head of Research.
About Solace Pharmaceuticals
Solace Pharmaceuticals discovers and develops innovative treatments for pain. Solace’s research and development programs are focused on exploiting novel biological understanding of disease targets that play a role in the pathogenesis of pain and that have disease-modifying potential in two key areas: modulating the activity of glial cells and intervening in the tetrohydrobiopterin (BH4) pathway. SLC022, the company’s lead drug candidate, is in phase II clinical development in patients with post-herpetic neuralgia (PHN). Solace’s research and development are supported by a strong and expanding intellectual property portfolio. For more information, please visit the company’s website at http://www.solacepharma.com.
Solace Pharmaceuticals
http://www.solacepharma.com
New Data Show Delta Dental Continues Offering Largest Nationwide Network
A new report shows that Delta Dental maintains the largest network of dentists in the nation, a position the nation’s largest dental benefit system has held for more than five decades. The report by NetMinder, an independent firm that provides data on providers and managed care networks to the healthcare industry, indicates that the Delta Dental network has more than 123,000 dentists, totaling more than 62,000 dentists than the next closest national competitor.
“Having the largest network of dentists in the nation is tremendously important because it offers cost savings to employers and employees through negotiated discounts, as well as convenience to our 51 million subscribers,” said Kim Volk, president and CEO of Delta Dental Plans Association. “Our network helped employers save more than $6 billion in decreased claims costs last year.”
Additionally, Delta Dental’s network is locally developed and controlled exclusively by its member companies, said Volk.
Delta Dental offers comprehensive benefits packages that combine cost-saving managed care features with flexible plan designs. Enrollees realize significant out-of-pocket savings from its “no balance billing” provision. Under this provision, dentists in the Delta Dental network accept negotiated fees as payment in full, and can’t pass costs along to patients for any differences between submitted charges and the charges allowed under Delta Dental’s contractual agreements. Enrollees seeking services from network dentists only have to pay deductibles and copayments required by their plans.
In addition to maintaining the largest network in the country, Delta Dental also regularly audits its network to ensure that all participating dentists meet comprehensive credentialing standards.
The not-for-profit Delta Dental Plans Association (http://www.deltadental.com) based in Oak Brook, Ill., is the leading national network of independent dental service corporations specializing in providing dental benefits programs to 51 million Americans in more than 93,000 employee groups throughout the country.
Delta Dental Plans Association
http://www.deltadental.com
Poor Sleep Linked To More Colds
US researchers found that people who slept fewer than seven hours a night, and who spent more of that time awake, were nearly three times more likely
to develop a cold than people who had eight hours or more of undisturbed sleep.
The study was the work of Dr
Sheldon Cohen, of the Department of Psychology at Carnegie Mellon University in Pittsburgh, Pennsylvania, and
colleagues, and was published in the 12 January issue of the Archives of Internal Medicine.
Poor sleep is thought to be a predictor of low immunity, and thereby more readily predisposing people to the common cold, although there is no direct
evidence tying sleep quality in the weeks leading up to exposure to the risk of infection. The researchers said that studies had also shown that people
who slept between seven and eight hours per night had the lowest rates of heart disease, illness and early death.
For this study, which took place between 2000 and 2004, Cohen and colleagues examined the links between sleep quality and sleep duration in the
weeks leading up to being exposed to a cold virus, to the susceptibility to catching it.
The researchers recruited 153 healthy male and female volunteers aged 21 to 55 years and interviewed them every day for fourteen days to find out how
long they had slept the previous night, how efficient their sleep had been, that is what percentage of the time in bed was actually spent sleeping, and
whether they felt rested. The researchers then worked out the average quantities of sleep duration and sleep efficiency for each person for the 14
nights.
The volunteers then went into quarantine and took nasal drops containing the common cold virus (rhinovirus). They were kept under close
observation for signs of a cold during the day before their exposure and for 5 days afterwards. They also gave mucus samples during this observation
period, which were tested for virus cultures, and 28 days or so later they gave a blood sample that was tested for antibody response to the cold virus.
Before the 14 days of monitoring, each participant also underwent a “pre-challenge” examination, where the researchers obtained information about
potential confounders such as virus-specific antibody levels in their blood, demographics, body mass index, psychological variables and health
behaviours.
The results showed that:
- The less a person slept, the more likely he or she was to develop a cold (there was a graded association between infection rate and average sleep
duration).
- Participants who slept fewer than 7 hours were 2.94 times more likely to develop a cold than those who had 8 hours or more sleep.
- The more efficiently a person slept (more of the time in bed actually spent asleep), the less likely he or she was to develop a cold (i.e. there was also a
graded association between sleep efficiency and rate of infection).
- Participants whose sleep efficiency feel below 92 per cent were 5.50 times more likely to develop a cold than those whose efficiency was 98 per
cent or more.
- Feeling rested was not linked to rate of infection.
- These relationships could not be explained by the potential counfounders such as levels of virus-specific antibodies beforehand, demographics, the
season of the year, body mass index, socioeconomic status, health behaviours, and psychological variables.
Cohen and colleagues concluded that:
“Poorer sleep efficiency and shorter sleep duration in the weeks preceding exposure to a rhinovirus were associated with lower resistance to
illness.”
The researchers also looked at separate components of illness and how they linked to the variables they measured.
“When the components of clinical illness (infection and signs or symptoms) were examined separately, sleep efficiency but not sleep duration was
associated with signs and symptoms of illness,” they wrote, but “neither was associated with infection.”
“A possible explanation for this finding is that sleep disturbance influences the regulation of pro-inflammatory cytokines, histamines and other
symptom mediators that are released in response to infection,” they suggested, recommending that seven to eight hours sleep a
night would appear to be a reasonable target.
The editors noted that the study was supported by the National Heart, Lung and Blood Institute, by the National Institute of Allergy and Infectious
Diseases and by supplementary funds provided by the John D. and Catherine T. MacArthur Foundation Network on Socioeconomic Status and
Health.
“Sleep Habits and Susceptibility to the Common Cold.”
Sheldon Cohen; William J. Doyle; Cuneyt M. Alper; Denise Janicki-Deverts; Ronald B. Turner.
Archives of Internal Medicine Vol. 169, No. 1, pp 62-67, January 12, 2009.
Click here for Abstract.
Sources: JAMA press release, journal abstract.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
