October 30, 2008 (San Diego, California) — An effort in Maryland to perform more screening colonoscopies has resulted in an increase in the number of early-stage colorectal cancer (CRC) cases and a decrease in regional CRC disease detected in the state, according to findings presented here at the American Public Health Association 136th Annual Meeting.

The push is part of the Healthy People 2010 campaign. One of the goals of that program is to increase to 50% the proportion of Americans 50 years or older who have ever undergone a colonoscopy or sigmoidoscopy.

This is an early finding, but “it’s a good indication, if it’s in fact true,” said lead author Jennifer Hayes, MEd, MPH, from the Maryland Cancer Registry, State of Maryland Department of Health and Mental Hygiene, in Baltimore, who presented the data in a poster session.

Using claims data maintained by the state, Ms. Hayes and colleagues determined the number of colonoscopies and sigmoidoscopies performed between 1999 and 2004. They also obtained hospital reports on CRC cases from the Maryland Cancer Registry. From these records, they found that the number of colonoscopies performed on Marylanders increased from 64,069 to 149,749 during the study period. The number of sigmoidoscopies declined from 23,553 to 3929. All in all, the percentage of people 50 years or older who had ever undergone a colonoscopy or sigmoidoscopy increased from 50% to 69%.

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Calando Pharmaceuticals, a majority-owned subsidiary of Arrowhead Research Corporation (NASDAQ:ARWR), announced today completion of the IT-101 Phase I clinical study conducted at City of Hope in Duarte, California. The company expects the entire study data to be published in early 2009. IT-101 is an experimental, nanoparticle therapeutic that consists of the drug camptothecin (CPT) conjugated to a cyclodextrin polymer. IT-101, the first drug candidate in Calando’s proprietary CyclosertTM pipeline, has now successfully completed a Phase I trial designed to evaluate its safety, tolerability, and pharmacokinetics in patients with inoperable or metastatic tumors.

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The positive opinion includes important survival data from the AZA-001 trial in higher-risk MDS patients. The CHMP, which reviews applications for all 27 Member States in the European Union (EU) as well as Norway and Iceland, has recommended approval for azacitidine. The CHMP’s positive opinion will be forwarded to the European Commission, which generally follows the recommendation of the CHMP and typically issues final marketing approval within two to three months.

“The CHMP recommendation is an especially important and positive milestone for Celgene. We are fully committed to deliver VIDAZA to patients in need throughout the EU,” said Philippe Van Holle, President of Celgene Europe. “We are optimistic that VIDAZA will have broad support based on its value to patients and to the healthcare system. Upon approval we are prepared to initiate next steps for pricing, reimbursement and distribution plans for all EU member states.”

“VIDAZA is the first drug to meaningfully extend overall survival for patients with higher-risk MDS, a group with limited options and median survival of about 15 months with classical treatments,” said Pierre Fenaux, M.D., Ph.D. of the Université de Paris and lead investigator of the AZA-001 survival trial. “VIDAZA, moreover, is very effective across a broad range of MDS subgroups, including RAEB in transformation, now classified as AML by the WHO classification - one of the largest subgroups in our study.”

The positive opinion from the CHMP was based upon safety and efficacy from clinical studies evaluating azacitidine in MDS-notably the significant improvement in overall survival achieved in the azacitidine survival trial (AZA-001), the largest, international randomized Phase III controlled study ever conducted in higher-risk MDS. The median overall survival for patients treated with azacitidine in the study was 24.5 months compared to 15 months for conventional care regimens (CCR), demonstrating a survival benefit of over nine additional months with a stratified log-rank p-value of 0.0001. The hazard ratio describing this treatment effect was 0.58 (95 percent confidence interval of 0.43 to 0.77). The extension of survival was seen across all patient subgroups including those greater than 65 years, as well as poorer prognostic groups such as those with WHO classified acute AML, which formed over 30 percent of the enrolled patients, and patients with poor risk cytogenetics. The two-year survival rate for patients with higher-risk MDS treated with azacitidine was almost doubled with 50.8 percent compared vs. 26.2 percent for patients treated with conventional care regimens (CCR). Patients treated with Vidaza received treatment for a median duration of nine cycles.

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Frank L. Meyskens, Jr., M.D., one of the “fathers” of the field of cancer chemoprevention, has been selected to receive the seventh annual American Association for Cancer Research (AACR)-Prevent Cancer Foundation Award for Excellence in Cancer Prevention Research.

The award is given annually to a scientist for seminal contributions to the field of cancer prevention research in basic, translational, clinical, epidemiological or behavioral science.

Meyskens, Professor of Medicine and Biological Chemistry and Director of the Chao Family Comprehensive Cancer Center, and Associate Vice Chancellor of Health Sciences at the College of Health Sciences University of California, Irvine, is being honored for his many significant contributions to the field of cancer prevention and control.

His early work examined the translation of laboratory-based chemoprevention into clinical trials. Meyskens led the development of the combination of difluoromethylornithine (DFMO) plus Sulindac to dramatically reduce the risk of advanced colorectal adenoma recurrence.

Among his noteworthy accomplishments, Meyskens developed the topical all-trans-retinoic acid for chemoprevention of cervical intraepithelial neoplasia (CIN), the first of the cellular changes that may develop into cervical cancer in some women. Additionally, he promoted the idea that retinol could be used to affect chronic myelogenous leukemia (CML).

Meyskens has re-examined the scientific basis for the etiology of melanoma. Based on 15 years of detailed laboratory work, he proposed a new conceptual framework for melanoma etiology, prevention, and treatment. Most recently, he has provided a major, new insight into the non-UVR causation of melanoma with suggestions for potential preventive strategies.

Meyskens has published many seminal “thought” papers that have moved the field of cancer prevention forward. Perhaps, the most influential and important papers in the past decade considered the many challenges associated with the identification and development of markers as predictors of preventive effectiveness.

Currently, Meyskens is continuing the clinical development of the Bowman-Birk inhibitor, a soybean-derived serine protease inhibitor, being tested as a human cancer-preventive agent.

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St. Baldrick’s Foundation, a non-profit organization dedicated to raising money for childhood cancer research, awarded $330,000 to fund Alex Huang, M.D., Ph.D., of Case Western Reserve University School of Medicine as a St. Baldrick’s Scholar for three years. St. Baldrick’s began as a challenge between friends, and has exploded into the world’s largest volunteer-driven fundraising program for childhood cancer research. Worldwide, 160,000 children are diagnosed with cancer each year and in the United States, cancer is the leading cause of death by disease among children.

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UroToday.com - In the online edition of The Prostate, Robert S. DiPaola and co-investigators reported their research on autophagy. Autophagy is a mechanism of cellular resistance or alternatively cell death. Cancer metabolism differs from normal cells in that it uses anaerobic glycolysis as opposed to oxidative phosphorylation to metabolize glucose. With nutrient deprivation, a cell response to starvation occurs whereby cellular organelles and bulk cytoplasm are targeted to lysosomes for degradation to supply an alternate energy source. Sustained autophagy under conditions of protracted cellular starvation is proposed to lead to cell death, thereby the survival or death consequences of autophagy are condition-dependent. Autophagy is proposed to be impaired in prostate cancer (CaP) due to activation of mTOR, which inhibits autophagy or through allelic loss of the essential autophagy gene beclin1. In this research, the effect of a prototypical inhibitor of glycolysis, 2DG, a glucose analogue that inhibits glucose uptake was assessed to determine if 2DG induces cytotoxicity and autophagy in CaP cells.

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UroToday.com - In the online version of the International Journal of Cancer, Dr. Sumit Isharwal and associates from Johns Hopkins University reported on the prognostic association between the Her-2/neu oncoprotein expression, abnormal DNA content and prostate cancer (CaP) progression. The investigators found a positive correlation.

The initial study cohort consisted of 252 men with clinically localized CaP treated with radical prostatectomy between 1980 and 1994. Patients were stratified into having Gleason score <7 or >7. For DNA content analysis, a minimum of 125 intact nuclei were captured from the cancer area for each patient. DNA content measurements were calculated and a % DNA index value generated. Her-2/neu expression in tissue sections was assessed by immunohistochemistry staining and counting. Patients were Her-2/neu negative, focally positive, and diffusely positive, if staining was present, in <5%, 5-30%, and >30%, respectively.

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Viruses - long regarded solely as disease agents - now are being used in therapies for cancer. Concerns over the safety of these so-called oncolytic viruses stem from their potential to damage healthy tissues. Now Mayo Clinic researchers have discovered a way of controlling the viruses behind potential cancer therapeutics. They are engineering the virus’s genetic sequence, using microRNAs to restrict them to specific tissues. The microRNAs destabilize the virus’s genome, making it impossible for the virus to run amok. The discovery is reported in the current issue of Nature Medicine.

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A team of scientists from the UK and other European countries has created a genetically modified (GM) purple tomato that in a pilot test significantly extended the life span of cancer-susceptible mice that were fed the new tomatoes compared to mice that were fed normal tomatoes.

The study was the work of Professor Cathie Martin from the John Innes Centre in Norwich and colleagues from research centres in Italy, Germany and The Netherlands, and was published online in the journal Nature Biotechnology on 26 October.

Martin and colleagues took genes from the snapdragon plant (Antirrhinum), inserted them into tomato plants and grew purple tomatoes high in anthocyanins, pigments that occur naturally at high levels in berry fruits such as the blackberry, cranberry and blueberry. There is evidence that anthocyanins protect against some cancers, cardiovascular disease, age-related degenerative diseases, diabetes, obesity and other illnesses.

The researchers already knew about the health protective properties of anthocyanins that occur in high levels in some edible plants, but were of the opinion that the levels found in many commonly eaten fruits and vegetables were not high enough to give the best health benefits.

As Martin explained:

“Most people do not eat 5 portions of fruits and vegetables a day, but they can get more benefit from those they do eat if common fruit and veg can be developed that are higher in bioactive compounds.”

Why tomatoes? Because they are an everyday food that already contain high levels of another important bioactive compound, the antioxidant lycopene. Highly processed tomatoes are the best source of lycopene. Tomatoes cooked in a little oil are as well, because this process helps to release lycopene from inside the cells of the fruit.

Another beneficial antioxidant found in in tomatoes and other food plants is flavonoids. These can be water soluble (hydrophilic) and fat soluble and eating foods with both types is thought to offer the best protection against disease.

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European researchers have developed highly sensitive ultrasound equipment that can detect tiny quantities of reflective microbubbles engineered to stick to specific tumour cells. The technique should pick up tumours early and improve patients’ chances of survival.

Most of the current diagnostic methods - biopsy analysis, biochemical tests and medical imaging - are not sufficiently sensitive. They frequently return a false negative; the tumour is only discovered when it is much bigger, and too late.

European researchers are developing a new technique that will help medical professionals visualise tiny quantities of pathological tissue in patients. The technology could localise tumours in their very earliest stages of development and help doctors begin treatments much earlier, giving patients a much better chance of survival.

The new approach uses medical ultrasound, a safe technology most commonly used for pre-natal visualisation of the foetus and the imaging of other soft tissues. A probe sends high-frequency acoustic waves into the body and detects how they bounce off the interfaces between different tissues.

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