Roche’s cancer drug Xeloda enabled elderly patients being treated for colorectal cancer to live free of the disease for longer, the world’s largest maker of cancer drugs said on Thursday.

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A study showed that patients above the age of 65 or 70 years who took Xeloda, or capecitabine, with Xelox, or oxaliplatin, immediately after surgery lived disease-free for longer compared with those treated with commonly used chemotherapy regimen 5-fluorouracil/leucovorin.

In July, Roche said Xeloda, which is already approved for the treatment of early-stage colon cancer as a monotherapy, increased the time patients lived when taken with oxaliplatin, meeting its primary goal in a late-stage trial.

Colorectal cancer is the second most common cause of death from cancer in men and women in Europe, with nearly 1 million cases each year worldwide, said Roche.

Age is the biggest risk factor for the disease and more than 90 percent of cases are diagnosed in individuals over the age of 50, Roche said.

Source: Reuters

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A gene known to shield the body from harmful chemicals may also protect against bowel cancer, a study suggests.

Dundee scientists found that removing a single gene from mice predisposed to cancers of the small intestine led to a 50-fold increase in tumours.

The rise in adenomas – pre-cancerous growths – appeared to be linked to increased inflammation of the bowel, the study in the journal PNAS reported.

The GSTP gene has previously been linked to a reduction in lung tumours.

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Several studies have shown it appears to provide protection to both the lungs and the skin against cancerous growths. But this latest research from the University of Dundee suggests in the bowel it may work in another way.

Specifically it found that there was more inflammation in the small intenstines of mice who had the GSTP gene removed.

Inflammation has already been associated with the risk of developing polyps – some types of which may go on to become cancerous, like adenomas – and it may be here that the gene plays a protective role.

Doctors already know of two genetic conditions which increase the risk of developing bowel cancer: FAP, or familial adenomatous polyposis, and HNPCC, which stands for hereditary non-polyposis colorectal cancer.

These conditions are however only responsible for about one in 20 cases of bowel cancer.

Inflammatory responses

The findings do not have any immediate clinical application, but experts note studies have suggested that certain types of food such as broccoli may boost GSTP levels.

“If this can be confirmed in humans, it could suggest another way of reducing the risk of bowel cancer,” said Dr Lesley Walker, director of cancer information at Cancer Research UK, which funded the research.

Dr Rob Glynne Jones, chief medical adviser at Bowel Cancer UK welcomed the latest research.

He said: “We are beginning to realise that inflammatory responses are very important – both in terms of a predisposition to cancer but also how you respond to treatment.

“We are in the process of unravelling the story, and a study like this is another piece of the jigsaw. Anything we can find out about possible causes helps us at every level – and what this looks like here is another potential pathway to disease.”

Professor William Steward of Beating Bowel Cancer said it was encouraging that this was a gene which could be influenced by diet.

“These findings lead to the possibility of developing approaches to preventing colorectal cancer,” he said. “Given the marked rise in the number of cases of bowel cancer, in particular among young people, this research could have important implications for reducing the risk and for tackling this worrying trend.”

Source: BBC NEWS

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Enzo Biochem obtained exclusive rights to market GeneNews’ ColonSentry™, a blood test for colorectal cancer, in New York and New Jersey. The company hopes to make the test available in the second half of 2010.

Enzo will work to validate and seek approval for the test pursuant to New York, New Jersey, and CLIA requirements. It will also be responsible for marketing and securing third-party reimbursement for the test.

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Enzo is GeneNews’ first U.S. regional marketing partner. ColonSentry is already available in Ontario and offers a noninvasive option for determining an individual’s current risk for colorectal cancer. It identifies telltale RNA biomarkers for early disease in blood samples.

“The greatest barrier to reducing mortality rates arising from colorectal cancer is patient compliance with screening,” according to Bernard Levin, M.D., chair of the GeneNews’ colorectal cancer clinical advisory board. “As a blood-based test, ColonSentry can encourage individuals to undergo screening, which could lead to earlier detection, thereby potentially reducing the suffering and death that can result from this highly treatable disease.”

Source: GEN News

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Neogenix Oncology, Inc. (Neogenix) announced today that NPC-1C, the company’s first IND (Investigational New Drug Application) was granted permission by the Food and Drug Administration (FDA) for the company to begin a Phase I trial.

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NPC-1C is derived from a colorectal cancer vaccine that had previously demonstrated safety and clinical activity in prior human studies. NPC-1C is a novel, monoclonal antibody intended for the treatment of advanced pancreatic and colorectal cancer.

This first human trial will evaluate the safety of NPC-1C in patients with late stage pancreatic or colorectal cancer. Anti-tumor activity has been demonstrated in both in-vitro ADCC assays and in multiple animal studies.

“The approval of our first IND for the initiation of our Phase I trial represents an important milestone toward the development of what could prove to be a breakthrough in cancer diagnostics and therapeutics,” said Neogenix President and Chief Medical Officer, Philip M. Arlen, MD. “This Phase I trial will evaluate NPC-1C in 12-24 patients with pancreatic or colorectal cancer and should provide important additional data regarding the safety and activity of our antibody. We expect the trial to complete enrollment in approximately 6-8 months.”

Neogenix Oncology is a cancer therapeutics and diagnostic company focused on developing innovative new products for a broad range of cancers.

The company’s portfolio includes monoclonal antibodies that have been shown to recognize tumor-specific immunogenic proteins derived from specific tumor subtypes. Neogenix Oncology monoclonal antibodies are unique in that they define the immunogenic tumor protein as both a diagnostic marker and as a therapeutic target for tumor destruction. This revolutionary approach could offer patients a new range of therapeutic alternatives in the future.

About Neogenix Oncology
Founded in 2004 and headquartered in Great Neck, NY, Neogenix Oncology, Inc., is a research-driven biopharmaceutical company that develops and commercializes innovative therapeutics and diagnostics for the management of solid tumors. Neogenix Oncology’s pipeline is derived in part from the Hollinshead library of clinically tested vaccines, with the potential to develop products for a wide range of cancers, including pancreas, colorectal, prostate, lung, ovarian, squamous, and others. The company conducts its research and development work in its laboratories in Rockville, MD. Please contact Neogenix Oncology at inquiries@neogenix.us for more information.

This press release may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management’s current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties.

Source: BUSINESS WIRE

Popularity: 2% [?]

New Phase III trial data suggests giving colon cancer patients Roche’s oral anticancer drug Xeloda in combination with intravenous oxaliplatin immediately after surgery boosts disease-free survival compared with combined postsurgery chemotherapy using 5-fluorouracil/leucovorin.

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The open-label international trial included 1,886 patients with stage III colon cancer who underwent surgery for their cancer. Roche says that it plans to use this data to apply for an extension to the Xeloda label.

Xeloda was first approved as first-line monotherapy for metastastic colorectal cancer in the U.S. and EU in 2001. Since then the drug has been sanctioned in a number of other countries for use as either monotherapy or in combination with other chemotherapies for the treatment of metastatic colorectal, breast, and pancreatic cancers, as well as advanced gastric cancer.

In 2008 Xeloda represented Roche’s eight best-selling pharmaceutical, with sales for that year reaching CHF 1.2 billion ($1.12 billion), up 13% from 2007. Growth in Japan was particularly strong, with sales in this market up 74%.

Source: GEN News

Popularity: 3% [?]

Pfizer announced Tuesday that it discontinued a Phase III study of Sutent (sunitinib) as a first-line treatment for patients with metastatic colorectal cancer. The drugmaker said an independent data monitoring committee found that the addition of Sutent to FOLFIRI chemotherapy in the SUN 1122 trial “would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared to FOLFIRI alone.”

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No new safety issues were identified, Pfizer stated, noting that it will continue to study Sutent in late-stage trials as a potential treatment for other cancer types, including advanced forms of breast cancer, non-small-cell lung cancer, hepatocellular carcinoma and hormone-refractory prostate cancer.

The drug had global sales of $847 million last year.

Source: FirstWord

Popularity: 2% [?]

Farrah Fawcett’s death today after a lengthy battle with anal cancer, which eventually spread to her liver, spotlights a rare type of the disease.

Anal cancer will strike an estimated 5,300 Americans and cause 710 deaths in 2009, according to the National Cancer Institute. One in 624 men and women will be diagnosed with cancer of the anus, anal canal, or anorectum during their life, which translates to a 0.16% lifetime risk of anal cancer.

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It is distinct from — and much less common than — colorectal cancer. Nearly 150,000 Americans are expected to be diagnosed with colon or rectal cancer this year, and about 50,000 will die. One in 19 Americans will be diagnosed with colon or rectal cancer. The five-year survival rates for the two diseases are similar, however, at around 65%.

The colon is the longest part of the large intestine and the rectum is the part of the large intestine closest to the anus. The anus is the opening of the rectum to the outside of the body.

Fawcett’s cancer remitted in 2007 before doctors told her it was back and had spread to her liver, according to the Los Angeles Times. She was 62 years old.

Source: The Wall Street Journal

Popularity: 3% [?]

Genentech’s recent deal with Bayhill Therapeutics is likely a result of the company realizing that if it wants to be a player in chronic illnesses, it needs to step outside its comfort zone of developing antibodies. Additionally, since label expansions for Avastin into the primary cancer setting look bleak, at least in the near future, Genentech will be trying to pep up its pipeline with novel approaches.

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The $350 million agreement with Bayhill covers a mid-stage DNA-based, antigen-specific immunomodulatory drug candidate for type 1 diabetes. The deal also marks the company’s first deal since being acquired by Roche. Until now Genentech’s technology franchise has rested firmly on partially or fully human mAbs aimed at specific immune-cell surface receptors to treat a variety of cancers.

Drawbacks of mAbs in Autoimmune Diseases
Genentech, now owned by Roche, also develops its antibodies to treat autoimmune diseases. It is currently seeking FDA approval for Rituxan® in DMARD-unresponsive rheumatoid arthritis, and for Xolair®, an anti-IgE antibody currently marketed to adults and adolescents, for pediatric asthma.

Ocrelizumab, a second generation anti-CD20 humanized mAb, is being developed with Biogen IDEC. It is currently in Phase III trials in rheumatoid arthritis and lupus nephritis. Said to be less immunogenic and cause less complement activation than Rituxan, this antibody may reduce the development of drug-neutralizing antibodies and infusion reactions.

mAbs, however, require regular IV infusions and can have serious side effects in some settings, because they compromise normal immune function. These may be acceptable therapeutics in an acute life-threatening disease setting such as cancer but can pose significant problems for use in chronic illnesses such as autoimmune diseases.

Avastin’s Potential?
Besides this limited setting for mAbs in chronic diseases, Genentech’s mAb-based cancer franchise is seeing some setbacks. The company’s strategy of finding additional applications for marketed products recently backfired with Avastin as an adjuvant therapeutic in early-stage colorectal cancer patients failing a late-stage study.

The drug, currently approved for patients with cancers that have spread beyond the breast, colon, and lung, already has blockbuster status. So far attempts to further expand this anti-VEGF antibody’s reach has not been successful. Such potential label expansions definitely played a role in Roche’s $95 per share, or $46.8 billion, takeover of Genentech.

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Following the announcement of the Avastin trial results, Roche’s stock plummeted to a 19-year low. The company had hoped that the drug, used in the adjuvant setting, would prevent tumor return and increase U.S. sales to $10 billion by 2015, according to some analysts’ projections.

Avastin now generates $4.8 billion globally in annual sales. U.S. sales of Avastin, considered the most important barometer of Genentech’s growth, rose 18% to $704 million toward the end of 2008 likely due to its increased use in treating breast cancer.

Fresh Approach: DNA-Based Antigen-Specific Drugs
Thus, while Genentech has profited handsomely in the past from the strategy of finding new uses for marketed drugs, its post-Avastin investment in Bayhill may represent a fundamental strategic change by taking a stake in a novel approach to autoimmune disease treatment. Genentech paid $25 million in cash and equity up front and agreed to pay development and sales milestones exceeding $325 million.

The terms of the exclusive, worldwide license cover development and commercialization of BHT-3021, a therapy based on Bayhill’s BHT-DNA antigen-specific immunomodulatory platform. The compound is intended to reduce or eliminate immune system attacks on insulin-producing pancreatic islet cells that result in type 1 diabetes.

“The BHT-DNA platform is based on plasmid DNA,” explains Bayhill CEO, Mark Schwartz, Ph.D. “We insert the gene for the protein that is the target of an autoimmune response, for example, proinsulin in the case of type 1 diabetes or myelin basic protein (MBP) in the case of multiple sclerosis, into a plasmid. Upon injection, the plasmid is taken up by antigen-presenting dendritic cells, which migrate to lymph nodes where they bind to the antiproinsulin T cells, thereby inactivating them and preventing them from attacking pancreatic islet cells.

“Preservation of C-peptide is what we want to see in treated patients,” Dr. Schwartz continues. “Placebo-treated patients experience a decline in C-peptide production over time as the insulin-producing cells of the pancreas are destroyed by the autoimmune response. C-protein is produced in a 50-50 ratio with insulin as proinsulin produced by pancreatic islet cells is enzymatically cleaved. The FDA accepts C-peptide as a marker of efficacy for type 1 diabetes therapeutics.”

Interim results of a Phase I/II trial testing this DNA-based, antigen-specific immunotherapy in patients with type 1 diabetes showed a preservation of C-peptide in treated patients compared to placebo and that BHT-3021 was safe and well tolerated among 42 patients who received one of four different doses of the drug over 12 weeks.

Understanding immune system mechanisms has evolved enough in the last few years to allow the development of antigen-specific, tolerance-inducing drugs. Dr. Schwartz notes that treatment of autoimmune diseases needs to be antigen specific. He characterizes the effects of general immunosuppressive agents as difficult for patients and physicians saying, “All antibody companies recognize that, in the end, antibodies and other immunosuppressants are bridges to antigen-specific approaches to treat these chronic diseases.”

Source: GEN News

Popularity: 3% [?]

Researchers identified NDRG4 to be a tumor suppressor gene in colorectal cancer. Additionally, they found that NDRG4 promoter methylation can be used as a biomarker for the detection of colorectal cancer from stool samples.

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The study is published online June 17 in the Journal of the National Cancer Institute and is called “N-Myc Downstream-Regulated Gene 4 (NDRG4): A Candidate Tumor Suppressor Gene and Potential Biomarker for Colorectal Cancer.”

To evaluate NDRG4’s role in colorectal cancer, the researchers analyzed NDRG4 promoter methylation and expression in human colorectal cancer cell lines, noncancerous colon mucosa, and colorectal cancer tissue using methylation-specific PCR and bisulfite sequencing. NDRG4 mRNA and protein expression were studied using real-time PCR and immunohistochemistry, respectively. Tumor suppressor functions of NDRG4 were examined by colony formation, cell proliferation, as well as migration and invasion assays in colorectal cancer cell lines that were stably transfected with an NDRG4 expression construct.

They found that the prevalence of NDRG4 promoter methylation in two independent series of colorectal cancers was 86% and 70% compared with 4% in noncancerous colon mucosa. NDRG4 mRNA and protein expression were decreased in colorectal cancer tissue compared with noncancerous colon mucosa. NDRG4 overexpression in colorectal cancer cell lines suppressed colony formation, cell proliferation, and invasion.

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Next, quantitative methylation-specific PCR was used to examine the utility of NDRG4 promoter methylation as a biomarker in fecal DNA from 75 colorectal cancer patients and 75 control subjects. The scientists found a sensitivity of 53% and a specificity of 100%.

Source: GEN News

Popularity: 2% [?]

Pfizer’s most advanced cancer program suffered a second blow with the company calling off Phase III trials evaluating Sutent as a first-line treatment of patients with advanced breast cancer. The independent Data Monitoring Committee found that the primary endpoint of superior progression-free survival would not be achieved.

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In April, Pfizer stopped a late-stage trial comparing Sutent to standard-of-care in advanced breast cancers citing a similar inability to significantly improve progression-free survival. Even with these first results from a program evaluating a combination therapy not showing an improvement, the firm says that it will continue on its path to evaluate Sutent in various regimens against solid tumors.

Sutent is already approved for gastrointestinal stromal tumors and advanced/metastatic renal cell carcinoma. It is in a slew of mid- to late-stage studies including advanced non-small-cell lung cancer, advanced colorectal cancer, advanced hepatocellular carcinoma, and advanced hormone-refractory prostate cancer.

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The latest trial to be stopped was evaluating Sutent plus paclitaxel versus bevacizumab plus paclitaxel. Ongoing Phase III trial investigations in advanced breast cancer include Sutent plus docetaxel versus docetaxel for first-line treatment and another looking at Sutent plus capecitabine versus capecitabine for second-line treatment. Analysis from both is expected by the end of the year or early next year.

Source: GEN News

Popularity: 3% [?]