Blood transfusions used to treat anemia in patients with cancer are associated with an increased risk of life-threatening blood clots, at a similar rate as other treatments for cancer-induced anemia, according to scientists at the University of Rochester Medical Center.

These findings, published in the Archives of Internal Medicine, pose a quandary for doctors who want to prevent thromboembolism one of the leading causes of illness and death in people with cancer.
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BloodCenter of Wisconsin today announced the availability of BCR-ABL Kinase Domain Mutation Analysis, a new DNA sequencing assay designed to help oncologists develop appropriate therapeutic strategies tailored to the specific needs of patients with chronic myeloid (or myelogenous) leukemia (CML).

The American Cancer Society estimates that physicians will diagnose approximately 5000 new cases of CML in the U.S. in 2008, and the National Donor Marrow Registry reports that more than 20,000 Americans currently have CML. Nearly all CML patients have a genetic abnormality known as BCR-ABL, and most CML patients are treated with Gleevec (imatinib; STI571), a targeted therapy that directly inhibits the molecular cause of the blood-borne cancer.

Unfortunately, clinical research has shown that a significant proportion of CML patients eventually develop resistance to Gleevec, resulting in a significant reduction in the drug’s effectiveness. By detecting clinically important abnormalities, known as BCR-ABL kinase domain mutations, the BCR-ABL Kinase Domain Mutation Analysis will help physicians determine appropriate therapies for their patients. For example, based on the quantitative results generated by BCR-ABL Kinase Domain Mutation Analysis, a physician might prescribe a higher dose of Gleevec, alternative targeted kinase inhibitors or other therapeutic agents to manage the cancer.

“Oncologists are fortunate to have a variety of treatments available for leukemia patients, and molecular assays that clarify the genetic abnormalities of the disease are crucial to allow us to recommend the most appropriate treatment for a patient with CML,” said Mark Juckett, M.D., director of the leukemia program at the University of Wisconsin Hospitals and Clinics. “BloodCenter of Wisconsin has once again provided the global cancer community with an important tool that will enhance patient care.”
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NCCN (The National Comprehensive Cancer Network) has been awarded a $1.5 Million grant from Bristol-Myers Squibb Company and ImClone Systems Incorporated to fund research on the antibody cetuximab in patients with bladder cancer. The novel targeted therapy has proven effective in various other types of cancer including colorectal and head and neck. The University of Michigan Comprehensive Cancer Center is the coordinating center for the study.

The National Comprehensive Cancer Network (NCCN), Bristol-Myers Squibb Company and ImClone Systems Incorporated have entered into a collaboration to conduct a multi-institutional, investigator-initiated study in bladder cancer using cetuximab (ERBITUX®, Bristol-Myers Squibb Company/ImClone Systems Incorporated). The University of Michigan Comprehensive Cancer Center is the coordinating center for the study supported by a $1.5 Million grant.
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Genzyme Corporation (Nasdaq: GENZ) announced today that it has filed a supplemental New Drug Application with the U.S. Food and Drug Administration for the use of Clolar® (clofarabine) to treat adult patients with acute myeloid leukemia (AML). The company has requested priority review of its application and, if granted, Clolar could be approved for this indication in the first half of 2009.

Clolar is currently approved in the United States and Europe for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients one to 21 years old who have received at least two prior treatments, and it is now a standard of care in this setting. Genzyme is developing clofarabine globally for the treatment of adult AML, earlier-line pediatric ALL, and myelodysplastic syndromes (MDS), broader indications that the company estimates could drive peak annual sales of the product to approximately $600 million.

“Clolar has an important role in the treatment of pediatric leukemia and has great potential to help a broader set of patients with hematological disorders,” said Beth Trehu, M.D., vice president and general manager for Clofarabine. “We are committed to fulfilling the potential of this product by expanding its indications and securing approvals globally.”

Supplemental NDA filing

AML is a cancer characterized by the rapid proliferation of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The condition is the most common acute leukemia affecting adults.

Genzyme’s supplemental NDA seeks approval for Clolar’s use as a single agent in previously untreated adults aged 60 years or older with AML who have at least one unfavorable prognostic factor. Many older AML patients with unfavorable prognostic indicators currently have poor outcomes using available induction chemotherapy. Clolar, if approved, would fulfill an unmet need for this difficult to treat patient population. Approximately 30 percent of older adult patients with AML receive any form of chemotherapy.

According to the American Cancer Society, in 2008 approximately 13,290 people will be diagnosed with acute myeloid leukemia (AML) in the United States, and most AML patients will be adults. The median age of a patient with AML is about 67 years.

The median survival for those patients receiving the current available induction chemotherapy-which is associated with high mortality-can vary from 1 to 13 months, and the 5-year survival rate over the past three decades remains at less than 10 to 15 percent. Older AML patients often have disease features such as an adverse cytogenetics profile or pre-existing blood disorders such as MDS that result in lower response rates and worse treatment outcomes compared to younger patients treated with conventional combination chemotherapy. In addition, current therapies are poorly tolerated in older patients with unfavorable risk factors, such as advanced age and poor performance status.

Genzyme will use the results of the CLASSIC II study to support its label expansion filing. This large Phase 2 clinical trial demonstrated that patients with at least one pre-specified unfavorable prognostic factor who received single agent Clolar achieved a 45 percent overall remission rate, including a 40 percent complete remission rate and a 5 percent complete remission rate with incomplete platelet recovery. These data were presented in June at the American Society of Clinical Oncology meeting. Updated data will be presented in December at the American Society of Hematology (ASH) meeting in San Francisco.

Importantly, the 30 day all-cause mortality, one of the study’s secondary endpoints, was 9.6 percent, which compares favorably to conventional induction chemotherapy, known as the “7 + 3″ regimen, where the 30 day induction mortality ranges from 10-30 percent up to 50-80 percent with increasing age and worsening performance status.

These patients had manageable treatment-related side effects. The most commonly occurring adverse reactions included nausea, febrile neutropenia, vomiting, diarrhea, rash, increased alanine aminotransferase, increased aspartate aminotransferase, fatigue, pneumonia, fever, headache, neutropenia, anorexia, mucosal inflammation, pruritus, and thrombocytopenia.
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DOR BioPharma, Inc. (DOR or the Company) (OTCBB: DORB), a late-stage biopharmaceutical company, announced today that the Therapeutics Goods Administration (TGA) of Australia has designated orBec(R) as an Orphan Drug for the treatment of patients with gastrointestinal Graft-Versus-Host-Disease (GI GVHD) following allogeneic hematopoietic cell transplantation.
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Exelixis, Inc. (Nasdaq:EXEL) today announced that Bristol-Myers Squibb Company (NYSE:BMY) has exercised its option to develop and commercialize Exelixis’ investigational new drug (IND) candidate XL413, a selective inhibitor of Cdc7. Under the terms of the collaboration agreement between the two companies, which became effective in January 2007, the selection of XL413 by Bristol-Myers Squibb entitles Exelixis to a milestone payment of $20 million. In addition, Exelixis has exercised its option under the collaboration agreement to co-develop and co-commercialize XL413 in the United States. Following the transfer of the XL413 development program, which is expected to occur promptly, Bristol-Myers Squibb will lead all global activities. The parties will co-develop and co-commercialize XL413 in the United States and share those profits 50/50. Exelixis will be entitled to receive double-digit royalties on product sales outside of the United States.

XL413 is the second compound selected by Bristol-Myers Squibb in this collaboration. Previously, in January 2008, Bristol-Myers Squibb exercised its option to select XL139, an inhibitor of the hedgehog signaling pathway, for further development and commercialization.

“To our knowledge, no other selective inhibitors of Cdc7 have advanced to this stage of preclinical development, giving XL413 the potential to become a first-in-class therapy,” said Michael M. Morrissey, PhD, President of Research and Development at Exelixis. “Our colleagues at Bristol-Myers Squibb have substantial expertise in developing and commercializing innovative cancer therapies, and we are excited to have another opportunity to work with them.”

“Providing innovative medicines to patients with cancer is central to our company’s mission,” said Francis Cuss, Senior Vice President, Discovery and Exploratory Clinical Research. “Cdc7 inhibition represents a novel approach to cancer treatment and we are pleased to add XL413 to our growing pipeline of cancer compounds, and to further expand our productive collaborations with Exelixis.”
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Varian Medical Systems (NYSE: VAR) today is introducing a new product that makes it easier for clinicians to store, manage and view images generated during cancer treatments. Varian will showcase its new OncoView™ image management and storage solution at the Radiological Society of North America (RSNA) meeting in Chicago, November 30 - December 4, 2008.

“OncoView provides oncology professionals with a reliable, scalable way of archiving and accessing the images and data that impact decisions about a patient’s course of treatment,” said Karla Knott, senior director of marketing for Varian’s Oncology Systems business. “It is designed specifically to archive information covering the entire cancer treatment process from diagnosis to survivorship and follow-up.”

Clinicians are using more images to make decisions and monitor progress over the course of cancer treatments. For image-guided radiotherapy, new images are generated at every step in the treatment process. “There is a vast — and growing — amount of images and related information that must be stored, and clinicians need a reliable system for easily archiving and instantly accessing this information in a meaningful way that is connected to the clinical “story line” for each patient,” says Erwin Nell, manager, systems marketing. “OncoView addresses this need. It supports archiving of the most commonly used imaging modalities in oncology care, including CT, MR, PET, kV X-rays, cone-beam CT, and electronic portal images. It also stores non-imaging data, including radiotherapy treatment plans, dose levels, and other important treatment details.”
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The latest annual report by leading cancer organizations in the US found that overall rates of new cancer cases and deaths have fallen for the first time since the report was first compiled ten years ago, but within those figures there are disturbingly large state and regional differences in lung cancer rates among women, highlighting the need to tighten tobacco control in many states.

The annual report, as usual, was compiled by researchers from the American Cancer Society (ACS), the Centers for Disease Control and Prevention (CDC), the National Cancer Institute (NCI), and the North American Association of Central Cancer Registries (NAACCR) and was published on 25 November in an online advance access issue of the Journal of the National Cancer Institute.
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Pancreatic cancer is one of the deadliest and most difficult to treat cancers. Now, in a major step forward, researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical Center have shown that administering radiation therapy prior to surgery nearly doubles survival in pancreatic cancer patients with operable tumors.

“Patients who received pre-surgical (neoadjuvant) radiation had almost double the overall survival compared with similar patients who didn’t undergo radiation, and survived significantly longer than patients who received radiation after the tumor was removed,” says the study’s senior author, Dr. David Sherr, assistant professor of clinical radiation oncology at Weill Cornell Medical College, and a radiation oncologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

The findings are published in the Nov. 15 issue of the International Journal of Radiation Oncology, Biology and Physics.

Pancreatic cancer remains the fifth deadliest malignancy in the United States, killing more than 32,000 Americans each year. It is typically not detected until it is already at an advanced stage when cure is rarely possible. In fact, the five-year survival rate for pancreatic cancer has been stalled at just 5 percent for the past 25 years.

Because pancreatic tumors have often spread or have directly invaded critical structures by the time they are detected, just 15 to 20 percent of patients are deemed suitable candidates for surgical removal (resection) of the tumor. And while post-operative radiotherapy has long been used to sterilize residual cancer cells that may not have been removed by surgery, the notion of using radiation before resection has been a controversial one.
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Light Sciences Oncology, Inc. (LSO) announced the completion of enrollment in a global Phase 3 clinical trial of Light Infusion Therapy(TM) (Litx(TM)) as a treatment for unresectable hepatocellular carcinoma (HCC), also known as hepatoma or primary liver cancer.

The two-armed, randomized clinical trial has enrolled 200 patients at sites in the Philippines, Korea, India, Malaysia, Thailand, Hong Kong, Singapore, Serbia, Poland, Croatia, and Italy. The primary endpoint of the clinical trial is to assess the survival of patients receiving Litx therapy versus those receiving standard-of-care therapies.

“We are pleased to have enrolled the final patient in this pivotal clinical trial of Litx in primary liver cancer,” said Llew Keltner, M.D., Ph.D., president and CEO of Light Sciences Oncology. “We look forward to seeing a statistically significant survival benefit of Litx and proceeding with a New Drug Application to the U.S. FDA, EMEA, and other regulatory authorities in 2009.”

HCC represents a great unmet medical need, with no effective treatments now available for the vast majority of patients. According to the 2005 edition of Cancer, Principles & Practice of Oncology, there are approximately one million new cases of HCC worldwide each year and, according to an article published in the Journal of Hepatology in 2004, HCC kills approximately one million people worldwide each year.

About Light-Infusion Therapy (Litx)

Litx is designed as an entirely new mode of therapy compared with the older, laser-based generation of light-activated drug therapies. The single-use, disposable Litx device uses light-emitting diodes (LEDs) to activate LS11(R) (talaporfin sodium), a light-activated, water-soluble drug. An LS11 molecule activated by the Litx system results in the production of singlet oxygen, which can kill target tissues with minimal side effects. Litx uses low-intensity light that causes vascular closure and apoptosis, or “programmed cell death.” Illumination with low-intensity light can activate each molecule of LS11 many times, resulting in a continuous supply of singlet oxygen molecules.

The Litx device contains a tiny array of LEDs at the end of a very narrow (only 1.2 mm wide) flexible coated micro-wire. Administering physicians insert the LED array into a tumor using a biopsy-like procedure, requiring only a mild anesthetic, followed by intravenous injection of LS11. The device emits red light at a discrete frequency and intensity, for a fixed time period, to activate LS11 and create a 2 cm by 4 cm “kill zone” around the LED array.

Litx attacks tumors from the inside-out, rather than outside-in, the method used in many standard treatments. It kills all tumor cells in the kill zone, rather than only the minority of cells undergoing rapid division. The Litx treatment closes tumor blood supply vessels, starving remaining cancer cells of oxygen and nutrients. The use of multiple light sources and multiple treatments is feasible and can be tailored based on the number, size, shape and location of the target tumors.
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