GlaxoSmithKline announced today
FDA approval of Avandamet(R) (rosiglitazone maleate and metformin HCl) for
use as initial treatment of type 2 diabetes as an adjunct to diet and
exercise. Avandamet was previously approved as a second-line therapy — it
was indicated for use in patients who were uncontrolled on metformin
monotherapy. Now, with this recent approval, physicians can start their
type 2 diabetes patients on Avandamet.

Avandamet is the only combination of a thiazolidinedione, rosiglitazone
maleate (separately marketed as Avandia(R)) and metformin HCl, with
approved use as initial therapy of type 2 diabetes. Avandamet is indicated
as an adjunct to diet and exercise to improve glycemic control in patients
with type 2 diabetes mellitus when treatment with dual rosiglitazone and
metformin therapy is appropriate.

The announcement of the FDA approval for Avandamet for use as initial
therapy in type 2 diabetes coincides with GlaxoSmithKline’s announcement
that its supply of Avandamet has been re-established.

“Many people with type 2 diabetes need to take more than one medication
to treat the disease in different ways. The combination of rosiglitazone
and metformin provides two complementary mechanisms of action,” said Barry
Goldstein, M.D., Ph.D., director, Division of Endocrinology, Diabetes and
Metabolic Diseases, Jefferson Medical College of Thomas Jefferson
University, Philadelphia. “Rosiglitazone targets insulin resistance, an
underlying cause of type 2 diabetes, whereas metformin primarily works to
reduce the amount of blood sugar (or glucose) produced by the liver. In
fact, a clinical trial comparing Avandamet to both rosiglitazone alone and
metformin alone showed that patients taking Avandamet achieved
significantly lower blood sugar levels than with either monotherapy alone.”

Nearly 18 million Americans have type 2 diabetes, the most common form
of diabetes. Type 2 diabetes is characterized by high blood sugar levels
that occur when the body does not produce enough insulin or does not
respond properly to its own natural insulin, a condition called insulin
resistance. To manage diabetes, it is important for patients to achieve the
blood sugar goal set by their physicians. Blood sugar control is measured
by the HbA1C test, or A1C, which reflects a person’s average blood sugar
levels over the previous two to three months. The American Association of
Clinical Endocrinologists recommends an A1C of 6.5% or lower. The American
Diabetes Association recommends an A1C of less than 7%. Lowering blood
sugar levels can help reduce the risk of diabetes-related complications,
such as heart disease, stroke, blindness, loss of limbs and kidney disease.

“GlaxoSmithKline is committed to developing diabetes therapies to treat
a disease that has reached epidemic proportions in the United States and
throughout the world,” said Anne M. Phillips, MD, vice president of
Clinical for North America Cardiovascular-Metabolic, GlaxoSmithKline. “With
the approval of Avandamet for use as initial therapy as an adjunct to diet
and exercise, GSK offers this effective and convenient option now for
initial treatment of type 2 diabetes. This combination of rosiglitazone and
metformin can help patients get their blood sugar under control.”

Importance of Aggressive Diabetes Management

Diabetes experts are setting more stringent standards that reflect the
importance of maintaining tight blood sugar control. “Combination therapy
with medications that work in different ways is often needed to help
patients reach and maintain blood sugar goals,” said Dr. Goldstein. “An
advantage of Avandamet is that it combines two medications with
complementary mechanisms of action in one convenient tablet.”

Avandamet: Initial Therapy in Diabetes Management

Avandamet was originally approved in the U.S. in 2002, and is available
in four tablet strengths of rosiglitazone/metformin, respectively: 2 mg/500
mg, 4 mg/500 mg, 2mg/1000mg, and 4mg/1000mg. Avandamet, as a two-in-one
therapy, is the most economical thiazolidinedione (TZD)-metformin
combination on the market.

Important Safety Information for Avandamet

Avandamet, along with diet and exercise, helps improve blood sugar
control. It is a combination of two drugs – rosiglitazone maleate and
metformin HCl.

A small number of people who have taken metformin, one of the
components of Avandamet, have developed a rare yet serious condition called
lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis
occurs most often in people with kidney problems and can be fatal in up to
one half of the cases. You should not take Avandamet if you have kidney
problems. Tests should be used to check your kidneys before and while
taking Avandamet. You should not drink alcohol excessively when taking
Avandamet. If you are taking medicines for heart failure, you may be at
increased risk of lactic acidosis.

Tell your doctor if you have heart problems or heart failure. Avandamet
can cause your body to keep extra fluid which leads to swelling and weight
gain. Extra body fluid can make some heart problems worse or lead to heart
failure. If you have swelling or fluid retention, shortness of breath or
trouble breathing, an unusually rapid increase in weight, or unusual
tiredness while taking Avandamet, call your doctor right away.

You should not take Avandamet if you have liver problems. Blood tests
should be used to check for liver problems before starting and while taking
Avandamet. Tell your doctor if you have liver disease, or if you experience
unexplained tiredness, stomach problems, dark urine or yellowing of skin
while taking Avandamet.

Tell your doctor about all of the medicines you are taking.
Avandamet may increase your risk of pregnancy.

Talk to your doctor before taking Avandamet if you could become
pregnant or if you are pregnant.

If you are nursing, you should not take Avandamet.

Your doctor should check your eyes regularly. Very rarely, some people
have experienced vision changes due to swelling in the back of the eye
while taking rosiglitazone, a component of Avandamet.

About GlaxoSmithKline

GlaxoSmithKline, one of the world’s leading research-based
pharmaceutical and healthcare companies, is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer.

Additional information about GlaxoSmithKline can be found online at
gsk.

GlaxoSmithKline
gsk

View drug information on Avandamet. Continue reading →

AstraZeneca announced enrollment of the first patient in the new GRAVITY study (Gauging the lipid effects of RosuvAstatin plus ezetimibe Versus sImvastatin plus ezetimibe TherapY). GRAVITY is a clinical trial examining the impact on LDL-cholesterol (‘bad’ cholesterol) levels in patients with hypercholesterolaemia and coronary heart disease following a treatment regimen with lower doses of CRESTOR plus ezetimibe, compared to higher doses of simvastatin plus ezetimibe (in a fixed dose combination marketed as VytorinTM or InegyTM). Ezetimibe is a cholesterol absorption inhibitor and this study is AstraZeneca’s first head-to-head comparison of CRESTOR/ezetimibe with simvastatin/ezetimibe.

CRESTOR provides comprehensive dyslipidaemia management, offering the most effective LDL-C reduction of any statin available, with the additional benefit of raising HDL across the dose range.

In a previous clinical trial, EXPLORER, CRESTOR 40mg with ezetimibe 10mg helped high risk patients achieve unprecedented levels of LDL-C reduction of up to 70% compared to 57% with CRESTOR alone.

“GRAVITY will, for the first time, examine the effects of adding ezetimibe to low dose CRESTOR and to simvastatin in a head-to-head clinical trial setting, to see which of these treatment options achieves the greatest LDL-C lowering benefits. We expect these results to firmly establish CRESTOR as the best statin upon which to base any combination therapy for patients with dyslipidaemia”, said Elisabeth Bj?¶rk, Global Medical Science Director for CRESTOR.

GRAVITY is a 12-week, open-label, randomised, parallel-group, multicentre, Phase IIIb study of 800 patients to compare the efficacy and safety of CRESTOR (rosuvastatin) 10mg and 20mg in combination with ezetimibe 10mg and simvastatin 40mg and 80mg in combination with ezetimibe 10mg in patients with hypercholesterolaemia and coronary heart disease (CHD) or a CHD risk equivalent, atherosclerosis or a 10-year CHD Risk of >20%. Complete results are due in 2009.

GRAVITY is a part of AstraZeneca’s extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, more than 69,300 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.

CRESTOR has now received regulatory approvals in over 90 countries across five continents. Over 11 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.

The 40 mg dose is the highest registered dose of CRESTOR. CRESTOR should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries, the usual starting dose of CRESTOR is 5mg or 10mg. The 40mg dose should be reserved for patients with severe hypercholesteraemia at high cardiovascular risk.

AstraZeneca

View drug information on Crestor. Continue reading →

ProRhythm, Inc. today
announced the treatment of the first patient with the company’s proprietary
HIFU (High Intensity Focused Ultrasound) Ablation System in the “focusAF”
clinical study for the treatment of Atrial Fibrillation (AF). This is a
critical step in the FDA approval process and comes after the successful
conclusion of the feasibility phase of the trial.

The “focusAF” trial, the pivotal trial in the FDA approval process,
will involve over 20 U.S. cardiac electrophysiology centers that specialize
in the treatment of Atrial Fibrillation. AF is an abnormal rhythm of the
heart, which can lead to stroke and other complications due to the
irregular pumping action of the atrium. It is estimated that AF currently
afflicts in excess of 6 million people worldwide.

The AF ablation procedure, commonly called Pulmonary Vein Isolation,
utilizes ProRhythm’s proprietary balloon catheter which is inserted through
a vein in the leg of the patient and advanced into the left atrium of the
heart. Controlled, discrete ablation lesions around the pulmonary veins,
created with the HIFU Catheter, are intended to prevent unwanted electrical
impulses from disrupting the heart’s normal rhythm.

The milestone procedure was performed at Beaumont Hospital in Royal
Oak, Michigan by Dr. David Haines. During the procedure, Dr. Haines was
able to position the HIFU Ablation Catheter at each of the 4 pulmonary
veins and successfully block electrical conduction from each of the
pulmonary veins to the left atrium of the heart.

“The HIFU catheter performed well in this procedure. The system was
able to deliver energy to the intended locations in a highly efficient and
effective manner. We are hopeful that the HIFU procedure will allow the
patients to lead a life that is free of Atrial Fibrillation,” said Dr.
Haines, Director, Heart Rhythm Center at Beaumont Hospital, following the
procedure. “We are pleased to be participating in this study as it could
provide us with a powerful new tool in the treatment of AF.”

“The initiation of the pivotal study is a critical step along the path
toward commercialization of our HIFU technology in the United States,” said
Reinhard Warnking, President and CEO of ProRhythm. “The acute results of
this first procedure mirror the results seen in the feasibility phase of
the trial. We are optimistic that long-term follow-up will demonstrate the
value of HIFU in the treatment of atrial fibrillation.”

About Beaumont Hospital

Beaumont is Michigan’s, and one of the nation’s, most experienced
providers of heart care, ranking tops in Michigan and 12th overall on the
2006 U.S. News & World Report list of the “Top 50″ hospitals for Heart and
Heart Surgery. Beaumont offers comprehensive, state-of-the-art heart care
at its Royal Oak and Troy hospitals and is dedicated to the prevention,
diagnosis and treatment of heart problems. Visit Beaumont on the web at
beaumonthospitals.

About ProRhythm

Since 1997, ProRhythm has pioneered the application of HIFU to advance
the minimally invasive treatment of complex medical conditions. In recent
years ProRhythm has concentrated its efforts on the development of HIFU for
the treatment of a debilitating arrhythmia, atrial fibrillation. AF is an
uncontrollable, rapid, heartbeat that results in a significant decline in
the quality of life and may lead to serious complications. Globally, in
excess of 6 million people are afflicted with AF and the current treatment
options are expensive, often inadequate and non-curative, as with the case
of drug therapy.

ProRhythm’s HIFU Ablation System is currently under investigation in
clinical trials in the United States to treat AF. ProRhythm believes that
its technology will eventually play a significant role in improving the
lives of countless individuals who are afflicted by atrial fibrillation.

Further information can be found at prorhythm.

ProRhythm, Inc.
prorhythm Continue reading →

Immunomedics, Inc. (Nasdaq:
IMMU), a biopharmaceutical company focused on developing monoclonal
antibodies to treat cancer and other serious diseases, today announced that
treatment with epratuzumab plus standard chemotherapy is feasible and well
tolerated in children with B-precursor acute lymphoblastic leukemia (ALL),
producing favorable early responses in the majority of patients. Elizabeth
Raetz, MD, pediatric oncologist at New York University, New York, in an
oral presentation at the 43rd Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Chicago, IL, reported results from this
multicenter feasibility/phase II study.

Fifteen patients with CD22-positive ALL in marrow relapse were enrolled
in the feasibility portion of the study. Nine patients were in first and 3
in second or later marrow relapse. Epratuzumab was given alone at 360 mg/m2
twice weekly for two weeks followed by 4 weekly doses of epratuzumab in
combination of standard cytotoxic chemotherapy. Within 24 hours of the
6-week treatment period, surface CD22 antigen was not detected on
peripheral blood leukemic blasts in all but one of the 12 assessable
patients, indicating effective targeting of leukemic cells by epratuzumab.
At the time of reporting, 9/12 patients (75%) achieved a complete
remission, of whom 7 showed no residual disease by flow cytometry; 1
patient had a partial response, 1 stable disease, and 1 with disease
progression.

“We are encouraged by these results. The phase-2 portion of the study
is now opened for enrollment of 112 patients, with a primary endpoint of
second complete remission rate,” commented Dr. Raetz, the study chair.

“We are pleased that COG shares our enthusiasm for epratuzumab and has
chosen to evaluate our antibody in their ongoing search for new treatments
for childhood leukemia. We will continue to expand the application of
epratuzumab to other B-cell malignancies,” remarked Ms. Cynthia L.
Sullivan, Immunomedics’ President and Chief Executive Officer.

The most common toxicities were grade-1/2 infusion reactions, which
occurred during the initial infusions only. Two non-hematological
dose-limiting toxicities occurred. One patient had a grade-4 seizure of
unclear etiology and one patient had asymptomatic grade-3 transaminase
elevation that returned to baseline prior to the time for the next
treatment cycle. All patients were able to resume infusions at a slower
rate after additional premedication.

About Acute Lymphoblastic Leukemia (ALL)

According to the American Cancer Society, an estimate of 2,790 children
before age 20, which represents 23% of new cases, will be diagnosed with
ALL in the United States in 2007 making ALL the most common cancer in
children and adolescents. About 85% of ALL is B-cell ALL, and the most
common subtype of B-cell ALL is B-precursor ALL. CD22 is expressed in more
than 90% of childhood B-precursor ALL. Although the 5-year survival rate
for ALL in children is 87%, the prognosis for a child with relapsed ALL
remains poor.

About Children’s Oncology Group

The Children’s Oncology Group (COG) is a network of more than 5,000
doctors, nurses and scientists who conduct clinical trials and perform
cutting-edge research to cure childhood cancer at more than 200 COG member
institutions. COG represents every pediatric cancer program in North
America, providing state-of-the-art medical and nursing care to more than
90% of children with cancer.

The multicenter feasibility/phase II study reported by Elizabeth Raetz,
MD, pediatric oncologist at New York University, New York, was supported by
grant CA-98543 from the National Cancer Institute and the Jeffrey Pryde
Foundation for Leukemia Research.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company focused on
the development of monoclonal, antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have
developed a number of advanced proprietary technologies that allow us to
create humanized antibodies that can be used either alone in unlabeled or
“naked” form, or conjugated with radioactive isotopes, chemotherapeutics or
toxins, in each case to create highly targeted agents. Using these
technologies, we have built a pipeline of therapeutic product candidates
that utilize several different mechanisms of action. We have licensed our
lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all
autoimmune disease indications worldwide. We have retained the rights for
epratuzumab in oncology indications for which UCB has been granted a buy-in
option. UCB has development, manufacture and commercialization rights, and
is responsible for all clinical trials evaluating epratuzumab for the
treatment of patients with moderate and severe lupus. At present, there is
no cure for lupus and no new lupus drug has been approved in the U.S. in
the last 40 years. The Company is conducting clinical trials with hA20 in
patients with non-Hodgkin’s lymphoma, epratuzumab as a potential
therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for
the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer
therapy and hCD74 as a therapy for patients with multiple myeloma. We
believe that our portfolio of intellectual property, which includes
approximately 108 patents issued in the United States, and more than 250
other issued patents worldwide, protects our product candidates and
technologies. We also have a majority ownership in IBC Pharmaceuticals,
Inc., which is developing a novel Dock and Lock (DNL) methodology, and a
new method of delivering imaging and therapeutic agents selectively to
disease, especially different solid cancers (colorectal, lung, pancreas,
etc.), by proprietary, antibody-based, pretargeting methods. For additional
information on us, please visit our web site at
immunomedics. The information on our website does not,
however, form a part of this press release.

This release, in addition to historical information, may contain
forward- looking statements made pursuant to the Private Securities
Litigation Reform Act of 1995. Such statements, including statements
regarding clinical trials, out-licensing arrangements (including the timing
and amount of contingent payments), forecasts of future operating results,
and capital raising activities, involve significant risks and uncertainties
and actual results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are not
limited to, risks associated with new product development (including
clinical trials outcome and regulatory requirements/actions), our
dependence on our licensing partner for the further development of
epratuzumab for autoimmune indications, competitive risks to marketed
products and availability of required financing and other sources of funds
on acceptable terms, if at all, as well as the risks discussed in the
Company’s filings with the Securities and Exchange Commission. The Company
is not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements, whether as a
result of new information, future events or otherwise.

Immunomedics, Inc.
immunomedics Continue reading →

to-BBB, the Dutch brain drug delivery company, announces that the Food and Drug Administration (FDA) has granted orphan drug designation for to-BBB’s brain cancer lead product 2B3-101.

As a proprietary brain-targeted version of the marketed product Caelyx®/Doxil® (PEG-liposomal doxorubicin), 2B3-101 uses glutathione (GSH) to safely enhance the delivery of doxorubicin across the blood-brain barrier. The therapeutic benefit and predictable safety profile of 2B3-101 has been successfully demonstrated in pre-clinical studies and the product is ready to start? clinical testing in a phase I/II study. 2B3-101 can be developed for multiple brain cancer indications and to-BBB considers development for brain metastases of breast cancer as well as glioma.
? 

Orphan drugs are developed for diseases which affect less than 200,000 people in the United States. The FDA has specifically granted the Orphan Drug Status of 2B3-101 for the treatment of glioma. This orphan drug designation qualifies to-BBB for an accelerated review process, tax credits, financial assistance for development costs, plus seven years of marketing exclusivity when 2B3-101 is approved by the FDA as treatment for glioma. The designation also allows for assistance in clinical trial protocol design. All these advantages will stimulate the development process of 2B3-101 for the treatment of glioma patients.

Recently, to-BBB has also received a positive opinion in the European Union by the Committee for Orphan Medicinal Products (COMP). With this additional approval by the FDA, the potential of to-BBB’s lead product 2B3-101 for brain cancer patients around the world is further acknowledged.

Continue reading →

Heart transplant patients who receive a donor heart from a person with hepatitis C have a lower rate of survival, according to a study in the October 18 issue of JAMA.

A shortage of cardiac organ donors results in a substantial number of deaths among persons awaiting cardiac transplantation. One potential approach for increasing the availability of donors is to broaden the criteria used to identify appropriate donors. For example, the cardiac donor pool could be expanded by using donors with hepatitis C virus (HCV) infection. Hearts from donors infected with HCV carry a substantial risk of transmission of HCV to the recipient, and high rates of subsequent liver enzyme abnormalities have been observed, according to background information in the article. The effect on patient survival has not been clear.

Leanne B. Gasink, M.D., M.S.C.E., of the University of Pennsylvania School of Medicine, Philadelphia, and colleagues conducted a study to determine the relationship between donor HCV status and survival in cardiac transplant recipients. The study included data from the Scientific Registry of Transplant Recipients. Adult heart transplant patients who received their transplants between April 1994 and July 2003 were eligible for inclusion. Of 10,915 patients meeting entry criteria, 261 received an HCV-positive donor heart.

The researchers found that the rate of death was higher among recipients of hearts from HCV-positive donors compared with recipients of hearts from HCV-negative donors at 1 year (16.9 percent vs. 8.2 percent), 5 years (41.8 percent vs. 18.5 percent), and 10 years (50.6 percent vs. 24.3 percent). At 1, 5, and 10 years, survival rates were 83 percent, 53 percent, and 25 percent for recipients of HCV-positive donor hearts, and 92 percent, 77 percent, and 53 percent for recipients of HCV-negative donor hearts, respectively. This association appears to be independent of recipient HCV status and age. Recipients of HCV-positive donor hearts were more likely to die of liver disease and coronary vasculopathy (disease of the coronary arteries).

“Preferential allocation of HCV-positive donors to HCV-positive recipients and/or older recipients is not warranted,” the authors conclude.

(JAMA. 2006;296:1843-1850.)

Internal funds provided by Division of Cardiology at the University of Pennsylvania were used to obtain data from the Scientific Registry of Transplant Recipients (SRTR). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Poorer Outcomes for Recipients of Heart Allografts From HCV-Positive Donors

In an accompanying editorial, Amir A. Qamar, M.D., and Robert H. Rubin, M.D., of Harvard Medical School and Brigham and Women’s Hospital, Boston, comment on the findings of Gasink and colleagues.

“The question that remains is how patients should be managed in the face of a potential organ donor who is HCV positive. The results of the study by Gasink et al, demonstrating a survival disadvantage among heart transplant recipients who had HCV-positive donors, provide support for the position that transplanting hearts from HCV-positive donors should be avoided if possible. Studies in other organ recipients suggest similar results. Exceptions could be made for critically ill patients who will not survive without a transplant.”

(JAMA. 2006;296:1900-1901.)

Financial disclosures – Dr. Rubin reports that he has received grants for research and education from Pfizer, Merck and Amgen.

Contact: Rick Cushman
JAMA and Archives Journals Continue reading →

New polymer material designed to
stop bone bleeding in surgery reduces the risk of surgical infection,
according to a new animal study to be published in the February 2008 issue
of Clinical Orthopaedics and Related Research (CORR). The study has
implications for lowering the risk of hospital-acquired infections,
including MRSA.

Researchers from the Medical University of South Carolina at Charleston
and Keck School of Medicine at the University of Southern California in Los
Angeles compared newly available polymer, Ostene(R), with bone wax,
traditionally used to stop bone bleeding in surgically cut bone surfaces.
The scientists looked at the two materials’ effect on bone infection in the
presence of Staphylococcus Aureus, similar to the organism that is
responsible for MRSA. The results showed that, when exposed to bacteria,
the bones treated with Ostene(R) were four times less likely to get
infected than the bones treated with bone wax, 100% of which developed
infection. The study also showed that the bones treated with Ostene(R)
healed normally, while the presence of bone wax inhibited bone growth.

Bone wax, a beeswax-based product, is the least expensive and most
commonly used bone hemostasis material despite its well-documented side
effects: Numerous studies indicate that bone wax interferes with the body’s
ability to clear bacteria and increases the risk of hospital-acquired
infections; it is also known to inhibit bone growth and bone healing after
surgery.

Ostene(R) offers an alternative that does not increase the risk to
patient. Its use in place of bone wax may help reduce serious
post-operative complications, including sternal wound infection and the
separation of the sternum. The material is used in cardiac, orthopedic,
oral, and neurosurgery. Other applications under development include the
use of Ostene(R) as a safe, soluble delivery vehicle for a variety of
therapeutic agents, from antibiotics to bone growth factors. Ostene(R) is
authorized for sale both in the U.S. and the European market.

Ostene(R) is a sterile mixture of water-soluble alkylene oxide
copolymers developed as an affordable, easy-to-handle synthetic bone
hemostasis material that reduces the overall risk of post surgical
infections, sternal non-union, poor bone healing and chronic inflammation.
Wax-like and malleable during application, the biomaterial dissolves
rapidly and is eliminated from the body shortly after surgery. The
material’s main polymer component inherently reduces bacterial adhesion.
Ostene(R) is the only available product designed to stop bone bleeding in
surgery that does not interfere with bone healing or add the risk of
surgical infections, including MRSA.

The results of the USC/MUSC study suggest that the use of Ostene(R) may
have implications for reducing the risk of surgical site infection and for
improving post-operative healing and recovery. The benefits of Ostene(R)
may be particularly significant in lowering the rates of serious
complications following cardiac surgery, especially among a growing
high-risk group of diabetic and overweight patients, who currently
represent at least 25% of the 640,000 open heart surgery procedures
performed each year in the US.

“Ostene(R)’s unique properties are particularly significant now that we
are battling the threat of hospital-acquired infections, especially MRSA,”
Ceremed’s president and CEO Tadeusz Wellisz, M.D., commented on the study.
“Ceremed is currently developing the next generation of Ostene(R) with
antibiotics, specifically designed to prevent hospital-acquired surgical
infection.”

About The Company:

Ceremed, Inc. is a privately held medical device corporation formed in
2002 by a surgeon and a group of scientists from the University of Southern
California. The company has unique expertise and a portfolio of innovative
proprietary technology in the field of soluble alkylene oxide copolymers.
These polymers have multiple medical applications, including bone
hemostasis and a delivery system for a variety of therapeutic agents.

Ceremed, Inc.
ceremed Continue reading →

UroToday – Our study investigates the performance of the Partin Nomogram using a cohort of patients identified in the National Cancer Institute, Surveillance Epidemiology, and End Results (SEER) database for the years 2004-2005. The Partin tables [1] attempt to predict the pathologic extent of disease found at radical prostatectomy by categorizing patients into mutually exclusive categories of positive lymph nodes, positive seminal vesicles, extracapsular disease, and organ confined disease. The Partin tables rely on pre-surgical PSA, biopsy Gleason score, and clinical T stage in assigning risk. We investigated the overall discriminatory and predictive performance of the Partin Tables, and also investigated the association of race and age with the Partin Table’s performance.

An interesting limitation of our analysis is that we could not use the pre-surgical biopsy Gleason score, but rather used the Gleason score found in the radical prostatectomy specimen. This is a limitation of the SEER database, as the Gleason score is reported from the largest pathological specimen. In the case of radical prostatectomy, it is the pathology specimen, not the pre-surgical biopsy. In essence, our study presumed perfect concordance between the biopsy assigned Gleason score, and the radical prostatectomy specimen assigned Gleason score. Though “over grading” is a well known phenomenon, there are signs that this is improving in the most recent contemporary studies. [2][3] Therefore, we feel that this limitation does not invalidate our analysis.

We found that race does not predict for more advanced pathology, when matched by PSA, Gleason score, and clinical T-stage. This was consistent with another large study investigating the association between Race and the performance of the Partin Tables.[4] Interestingly, we found that younger age predicted for more advanced pathology compared to older age, and that the Partin Tables performed the best for young men under 61 years of age. This could be due to a multitude of factors, including the relative youth of the Johns Hopkins Medical Institute cohort (the group of patients used to “build” the Partin Tables), and the greater incidence of benign prostatic hypertrophy – attributable PSA in older men, perhaps increasing the perceived (but not actual) risk of advanced disease in these men. There could also be yet-undefined differences in cancer biology between younger and older men with prostate cancer, not taken into account by Gleason score, PSA, and clinical T-stage.

In conclusion, we showed excellent discrimination of the Partin tables for seminal vesicle invasion and positive lymph nodes. However, we found an interesting difference in the performance of the Partin tables between younger and older men.

[1] Makarov DV, Trock BJ, Humphreys EB et al. Updated nomogram to predict pathologic stage of prostate cancer given prostate-specific antigen level, clinical stage, and biopsy Gleason score (Partin Tables) based on cases from 2000 to 2005. Urology 2007;69:1095-1101.

[2] Fine SW, Epstein JI. A contemporary study correlating prostate needle biopsy and radical prostatectomy Gleason score. J Urol. 2008;179:1335-8.

[3] Rajnikanth A, Manoharan M, Soloway CT, et al: Trends in Gleason score: concordance between biopsy and prostatectomy over 15 years. Urology. 2009;72:177-82.

[4] Heath EI, Kattan MW, Powell IJ, et al. The effect of race/ethnicity on the accuracy of the 2001 Partin Tables for predicting pathologic stage of localized prostate cancer. Urology 2008;71:151-155.

Written by James B. Yu, MD as part of Beyond the Abstract on UroToday. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations, etc., of their research by referencing the published abstract.

UroToday – the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
urotoday

Copyright © 2010 – UroToday Continue reading →

A person who opts for healthy lifestyle choices can have an 80% lower risk of first time stroke compared to individuals who do not, scientists have revealed in an article in the medical journal Stroke. Of the 795,000 strokes that occur in the USA, over 77% are first events, the authors explain. After heart disease and cancer, stroke is the biggest cause of premature death in America. It is a major cause of disability.

New stroke prevention guidelines, which had previously been updated in 2006, are being issued.

The researchers say two factors can significantly reduce the incidence of first time strokes:

Health lifestyle choices
Emergency room interventions

Larry B. Goldstein, M.D., director of the Duke Stroke Center in Durham, N.C., said:
“Between 1999 and 2006, there’s been over a 30 percent reduction in stroke death rates in the United States and we think the majority of the reduction is coming from better prevention.”
Up to 1999 stroke incidence had been on the rise. There had been a 39% increase in hospitalizations due to stroke from 1988 through 1997.

The authors say the stroke rate in America will rise because people are living longer.

This time the stroke prevention guidelines address the condition as a broad continuum of related events, including ischemic stroke, non-ischemic-stroke and TIA (transient ischemic attack).

A stroke is a condition in which a blood clot or ruptured blood vessel interrupts the flow of blood to a specific area of the brain. Lack of glucose and oxygen flowing to the brain results in the death of brain cells and subsequent brain damage. The patient may have problems with speech, memory and movement. There are two main types of stroke:
Ischemic stroke – represent about 87% of all strokes. A thrombus (blood clot) forms, blocking blood flow to a part of the brain. Sometimes the clot can form in another part of the body, becomes dislodged and free-floating (an embolus). The embolus can make its way through the bloodstream to the brain where it can cause an ischemic stroke.
Hemorrhagic stroke (non-ischemic stroke) – a blood vessel ruptures. The leaking blood fills the space between the brain and skull (subarachnoid hemorrhage). Can also occur if a defective artery in the brain bursts and fills the surrounding tissue with blood (cerebral hemorrhage). In both cases there is poor bloodflow to the brain, plus the accumulation of leaking blood places excessive pressure on the brain.

A transient ischemic attack (TIA), also known as a mini-stroke, is a temporary interruption of blood flow to a part of the brain. TIA symptoms may be similar to a stroke, however they last for a shorter time and do not leave noticeable permanent damage. TIAs are considered major risk factors for a later, larger stroke.

Goldstein said there is little difference along the stroke spectrum for effective prevention.

Highlighted below are some major updates in the new stroke prevention guidelines:

Healthy lifestyle choices – don’t smoke, follow a healthy low fat diet with plenty of fruits and vegetables, if you consume alcohol do so in moderation, keep your body weight within normal limits, and exercise regularly. People who adopt ALL these lifestyle choices can have an 80% lower risk of developing a stroke.
Emergency room doctors – attempts should be made to spot those who are at high risk for stroke. The doctors should consider screening, referrals, or even starting preventive treatment.
Genetic screening – not recommended for the general population. However, in some cases, depending on family history and some other factors, screening might be appropriate.
Stenting vs. endarterectomy – this is still uncertain. Doctors need to view each case individually, and take into account advances in standard medical therapies, including hypertension treatment, administering antiplatelet and cholesterol lowering medications, and encouraging healthy lifestyle choices.
Carotid artery narrowing screening – no recommended for the general population.
Aspirin – for low risk individuals, patients with diabetes, and those with asymptomatic peripheral artery disease aspirin does not help prevent a first stroke. Aspirin is recommended for patients whose stroke risk is higher than bleeding risk (which aspirin can cause).

“Guidelines for the primary prevention of stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association”
Goldstein LB, Cheryl D. Bushnell, M.D., M.H.S.; Robert J. Adams, M.S., M.D.; Lawrence J. Appel, M.D., M.P.H.; Lynne T. Braun, Ph.D., C.N.P.; Seemant Chaturvedi, M.D.; Mark A. Creager, M.D.; Antonio Culebras, M.D.; Robert H. Eckel, M.D.; Robert G. Hart, M.D.; Judith A. Hinchey, M.D., M.S.; Virginia J. Howard, Ph.D.; Edward C. Jauch, M.D., M.S.; Steven R. Levine, M.D.; James F. Meschia, M.D.; Wesley S. Moore, M.D.; J.V. (Ian) Nixon, M.D.; and Thomas A. Pearson, M.D.
Stroke Journal 2010; DOI:10.1161/STR.0b013e3181fcb238

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ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) today announced the initiation of a Phase II clinical
trial using CoFactor(R) in the treatment of refractory metastatic breast
cancer. CoFactor (ANX-510) is a folate-based biomodulator drug designed to
enhance the activity and reduce associated toxicity of the widely used
cancer chemotherapeutic agent 5-fluorouracil (5-FU).

This study builds on the results of earlier studies and will more fully
investigate the efficacy and safety of CoFactor for patients with
previously treated, advanced breast cancer.

“The initiation of this Phase II clinical trial for CoFactor represents
an important milestone in the global registration strategy for our lead
product development program,” said Evan M. Levine, chief executive officer
of ADVENTRX. “We are enthusiastic about CoFactor’s potential to enhance the
efficacy and safety of 5-FU chemotherapy in the treatment of refractory
breast cancer.”

“We are pleased to have launched this study of CoFactor in combination
with 5-FU in advanced breast cancer,” added James A. Merritt, MD, president
and chief medical officer of ADVENTRX. “The CoFactor and 5-FU regimen has
demonstrated activity in multiple tumor types, including breast in a Phase
I clinical trial, and we have safety data from other CoFactor studies in
metastatic colorectal cancer that suggest CoFactor is well-tolerated. We
believe a CoFactor plus 5-FU regimen could offer a worthwhile alternative
in the overall management of breast cancer.”

This Phase II clinical trial is a single arm, multicenter study to
evaluate the safety and efficacy of treatment with CoFactor plus 5-FU in
advanced breast cancer patients who have failed anthracycline and taxane
chemotherapies. Patients will be treated with CoFactor followed by 5-FU
administered by IV bolus weekly for 6 weeks, with tumor and safety
assessments every 8 weeks. The primary endpoint for the study is objective
response rate (RECIST criteria), and secondary endpoints are duration of
response, progression free survival, overall survival and incidence and
severity of adverse events (AEs), as defined by the NCI Common Terminology
Criteria. A total of 31 patients are expected to be enrolled at 6 clinical
sites.

According to the American Cancer Society, breast cancer is the most
frequently diagnosed cancer in American women and the second leading cause
of cancer-related deaths in women after lung cancer. Over 214,000 new cases
of breast cancer and over 41,000 deaths from breast cancer are expected in
the US in 2006. Despite advances made in treatment options that have led to
a significant increase in survival and quality of life, metastatic disease
is still incurable. Five-year survival rates decrease with advancing
disease stage: from 98% in localized disease to 80% with regional spreading
to only 26% with metastatic disease.

About CoFactor

CoFactor (ANX-510) is a folate-based biomodulator drug designed to
replace leucovorin to enhance the activity and reduce associated toxicity
of the widely used cancer chemotherapy 5-fluorouracil (5-FU). In comparison
to leucovorin, CoFactor creates more stable binding of the active form of
5-FU to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the
chemical pathway required by leucovorin to deliver the active form of
folate, allowing 5-FU to work more effectively. In addition to the Phase II
breast cancer trial, CoFactor is being studied in first-line treatment of
metastatic colorectal cancer in a Phase IIb and pivotal Phase III clinical
trial.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical research and
development company focused on commercializing low development risk
pharmaceuticals for cancer and infectious disease that enhance the efficacy
and/or safety of existing therapies. More information can be found on
ADVENTRX’s web site at adventrx.

Forward Looking Statement

ADVENTRX cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements that involve risks, uncertainties, assumptions and other factors
that, if they do not materialize or prove to be accurate, could cause
ADVENTRX’s results to differ materially from historical results or those
expressed or implied by such forward-looking statements. Such
forward-looking statements are made based on management’s current
expectations and beliefs and should not be regarded as a statement or
representation by ADVENTRX that any of its plans, including its anticipated
milestones, will be achieved on time or at all. The potential risks and
uncertainties that could cause actual results to differ materially include,
but are not limited to: the risk that ADVENTRX will be unable to raise
sufficient capital to fund the projects necessary to meet its anticipated
or stated goals and milestones; the potential to attract a strategic
partner and the terms of any related transaction; the ability to timely
enroll subjects in ADVENTRX’s current and anticipated clinical trials; the
results of pending clinical trials for CoFactor(R) or ADVENTRX’s other
product candidates; the potential for CoFactor(R) and ADVENTRX’s other
product candidates to receive regulatory approval for one or more
indications on a timely basis or at all, and the uncertain process of
seeking regulatory approval; other difficulties or delays in developing,
testing, manufacturing and marketing of and obtaining regulatory approval
for CoFactor(R) or ADVENTRX’s other product candidates; the market
potential for fluoropyrimidine biomodulators and other target markets, and
ADVENTRX’s ability to compete in those markets; unexpected adverse side
effects or inadequate therapeutic efficacy of CoFactor(R) or ADVENTRX’s
other products that could delay or prevent regulatory approval or
commercialization, or that could result in recalls or product liability
claims; the risk that preclinical and clinical results are not indicative
of the success of subsequent clinical trials and that products will not
perform as preclinical and clinical data suggests or as otherwise
anticipated; the potential for regulatory authorities to require additional
preclinical work or other clinical requirements to support regulatory
filings; the scope and validity of patent protection for CoFactor(R) and
Adventrx’ other product candidates; and other risks and uncertainties more
fully described in ADVENTRX’s press releases and periodic filings with the
Securities and Exchange Commission. ADVENTRX’s public filings with the
Securities and Exchange Commission are available at sec.

You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date when made. All forward-looking
statements are qualified in their entirety by this cautionary statement and
ADVENTRX assumes no obligation to revise or update any forward-looking
statement, including as set forth in this press release, to reflect events
or circumstances arising after the date on which it was made.

ADVENTRX Pharmaceuticals, Inc.
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