PharmaMar has received the Award “Supporting A Cure In Our Time” from the Sarcoma Foundation of America (SFA) for its “support in the search for an effective cure for soft tissue sarcomas,” goal of the foundation, during the congress of the Connective Tissue Oncology Society (CTOS) held in London from 13-15 November. In the words of Matthew Alsante, Executive Director of the SFA: “It is with great pleasure that I present PharmaMar with a “Supporting A Cure in our Time” Award. PharmaMar has been a leader in sarcoma research and treatment, a cancer population that is very undeserved. It is with great appreciation that the Sarcoma Foundation of America recognizes PharaMar for their innovative efforts to improve the care and lives of patients affected with sarcoma. With few new and effective treatments for sarcoma patients, the development of Yondelis as a treatment option has been an important breakthrough for sarcoma patients.”

The mission of the Sarcoma Foundation of America (SFA) is to act as an advocate for greater research to find new and better therapies with which to treat patients with sarcoma. The SFA raises its own funds to provide research grants to researchers from sarcoma. The SFA also interacts with the public and private sectors and with non-profit organizations to raise awareness of the needs for treatment of patients with sarcoma.

PharmaMar commercializes Yondelis in the EU for the treatment of soft tissue sarcoma in adults, after failure of standard treatment. PharmaMar will start a phase III multicenter study of Yondelis as first-line therapy in patients with tumor traslocation, Ewing’s sarcoma, or not rhabdomyosarcomatose soft tissue sarcomas. Also, Yondelis is being studied in solid tumors with high incidence and prevalence in the population, such as prostate, breast and lung cancer.
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ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it presented positive data from a Phase I study of palifosfamide (ZymafosTM) in combination with doxorubicin at the 14th Annual Connective Tissue Oncology Society (CTOS) meeting held in London, UK, November 13 to 15. Also presented was an update of the data from the Phase II trial of palifosfamide used as a single agent in advanced sarcoma.

The Phase I trial of palifosfamide in combination with doxorubicin was fully enrolled with 13 metastatic patients, of whom 8 were still receiving therapy. The combination was well tolerated with no dose-limiting toxicities reported during a total of 51 cycles of treatment. Of 12 evaluable patients, 3 had partial responses. Of the 8 patients with soft tissue sarcoma (STS), 2 had partial responses and the remaining 6 patients were progression free with a median duration of follow-up of 15 weeks and were still on therapy.

The update from the Phase II trial investigating palifosfamide as a single agent against advanced STS revealed 3-month progression free rates of 45% overall and 55% in ifosfamide-naïve patients. The 6-month progression free rate was 23% at 6 months. These data show that palifosfamide is highly active in STS.

In both studies, none of the 19 patients who have been treated with the novel palifosfamide-T (TRIS/mannitol drug product) experienced renal toxicity nor bladder toxicity or encephalopathy commonly associated with ifosfamide treatment.
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New data shows that some sarcoma patients are benefiting from treatment with REOLYSIN, developed from a harmless virus called the reovirus that most people are exposed to at some point in their lives.

Dr. Monica Mita of the Institute of Drug Development (IDD), the Cancer Therapy and Research Center at the University of Texas Health Science Center, (UTHSC), San Antonio, Texas, delivered her findings at both the Connective Tissue Oncology Society (CTOS) annual meeting in London, U.K. and the Chemotherapy Foundation Symposium XXVI in New York in November 2008. Her oral presentation discussed the interim results of a U.S. Phase II trial investigating intravenous REOLYSIN® in patients with bone and soft tissue sarcomas metastatic to the lung.

“The standard treatment for this type of sarcoma is chemotherapy, but prognosis is poor since there is no cure,” said Dr. Mita. “Patients with only a few months to live face poor quality of life because chemotherapy treatments are so harsh. The goal is to introduce less invasive approaches that help extend life and provide patients with a better quality of life.”

REOLYSIN, being developed by Oncolytics Biotech Inc, a Calgary-based company, preferentially replicates in cancer cells with an activated RAS pathway. Approximately two thirds of all cancers have an activated RAS pathway, including most metastatic disease. The reovirus is a segmented double-stranded RNA virus that causes only mild illness in humans. Although the virus replicates robustly in cancer cells expressing Ras, a cancer signaling pathway, it spares normal cells. Viral replication within cancer cells causes them to burst open, releasing more virus to infect other cells.
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Current estimates for head and neck cancer survival are largely inaccurate because they widely disregard many of the most common diseases such patients have in addition to their primary cancer, says Jay Piccirillo, M.D., a head and neck specialist at Washington University School of Medicine in St. Louis, the Siteman Cancer Center and Barnes-Jewish Hospital.

This highlights a broader problem with cancer survival statistics, which generally don’t take into account the effect of co-existing conditions, or comorbidities, according to Piccirillo.

In a recent study, Piccirillo, director of the Clinical Outcomes Research Office at Washington University School of Medicine and professor of otolaryngology, showed that the risk of death increased up to seven-fold when patients with head and neck cancer developed new or more severe co-existing ailments such as heart problems, diabetes or lung disorders after cancer diagnosis.
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Coaxing a patient’s own cells to hunt down and tackle infected or diseased cells is a promising therapeutic approach for many disorders. But until now, efforts to follow these specially modified cells after their reintroduction to the body have relied on short-term monitoring techniques that don’t give a complete picture of the cells’ status.

Now, for the first time, researchers at the Stanford University School of Medicine have devised a way to obtain repeated “snapshots” of the location and survival of such cells in a living human patient months and possibly years later. This is good news for individual patients and clinicians who may want to assess the cells’ disease-fighting performance over time, as well as for researchers trying to design more effective cell-based therapies.

“This has never before been done in a human,” said the senior author of the research, Sanjiv Gambhir, MD, PhD, director of Stanford’s Molecular Imaging Program. “Until now, we’ve been shooting blind-never knowing why failed therapies didn’t work. Did the cells die? Did they not get where we wanted them to go? Now we can repeatedly monitor them throughout their lifetime.” Gambhir is a professor of radiology and a member of Stanford’s Cancer Center. He collaborated with researchers at City of Hope in Los Angeles and at UCLA to conduct the research.

Gambhir and his colleagues tested the technique in a middle-aged man with an aggressive brain tumor (called a glioblastoma) who was enrolled in a clinical trial of cell-based therapy at City of Hope. However, they believe similar strategies will work to monitor cell-based therapies for many disorders. The results of the case study will be published online Nov. 18 in Nature Clinical Practice Oncology.
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The Lymphoma Association is delighted to launch their latest short film which shows the services they offer to anyone affected by lymphoma - the UK’s sixth most common cancer.
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Gentium S.p.A. (NASDAQ: GENT) announced today interim results from an independent Data Safety Monitoring Board (DSMB) review of the Company’s Phase 3 treatment trial of Defibrotide for Severe Veno-Occlusive Disease (VOD). The DSMB reported that in order for the study to be 80% powered to detect a p-value of .01, the necessary statistical hurdle under the current protocol for FDA approval, the sample size should be increased to 160 patients in the treatment arm and 80 patients in the historical control arm. The DSMB also noted that a sample size of 102 patients in the treatment arm and 51 patients in the historical control arm would be needed to achieve a p-value of .05. Furthermore, the DSMB indicated that the data presented thus far do not raise any safety concerns and did not recommend that the trial be stopped for futility.

Gentium also announced today the preliminary results of an independent Medical Review Committee’s (MRC) selection of historical control patients in the trial. Following the results of a prior DSMB meeting announced on June 5, 2008 in which the DSMB expressed concerns regarding the practical application of the criteria used to enroll historical control patients, the MRC met to re-review the criteria and eligibility of all historical control cases. After reviewing the available information, the MRC was only able to conclude that 32 out of the 86 patients initially included in the historical control arm definitively met the eligibility criteria and had a confirmed diagnosis of severe VOD. There are currently 102 patients enrolled in the treatment arm of the study.

“While we were hoping to be in a better position following the reviews of the DSMB and MRC concerning our Phase 3 trial, we remain committed to the development of Defibrotide,” said Dr. Laura Ferro, CEO of Gentium. “We do not intend to enroll the additional number of patients required to achieve a p-value of .01; however, we are evaluating the possible enrollment of additional patients in the historical control arm, which would allow us greater potential to achieve a p-value that could be used as supportive data in favor of an approval of Defibrotide.”
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A new class of compounds called phosphaplatins can effectively kill ovarian, testicular, head and neck cancer cells with potentially less toxicity than conventional drugs, according to a new study published this week in the journal Proceedings of the National Academy of Sciences.

The compounds could be less harmful than current cancer treatments on the market such as cisplatin and carboplatin because they don’t penetrate the cell nucleus and attach to DNA, said lead author Rathindra Bose. Conventional drugs can interfere with the functions of the cell’s enzymes, which lead to side effects such as hearing and hair loss and kidney dysfunction.

Though scientists don’t fully understand the mechanism by which the phosphaplatins kill cancer cells, they suspect that the compounds bind to the cell surface membrane proteins and transmit a “death signal” to the interior of the cell, Bose said. The compounds are created by attaching platinum to a phosphate ligand, which can readily anchor to the cell membrane. Future studies will focus on identifying the exact process.
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Physicians in the U.S. are reporting a higher risk for certain types of cancers — such as liver, head, neck and lung — in people living with HIV/AIDS, raising concerns that a cancer epidemic is imminent in the population, the Baltimore Sun reports. According to the Sun, Meredith Shiels, a doctoral candidate at the Johns Hopkins Bloomberg School of Public Health, presented a paper on Tuesday at the seventh annual American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research that said people living with HIV are twice as likely as the general population to develop cancers not previously linked with the virus. Other studies have found that people living with HIV have as much as a 10 times greater chance of developing certain cancers compared with the general population. William Blattner, an associate director of the University of Maryland Institute of Human Virology, said researchers are “really at the first stages of systematically looking at the epidemic and fully looking at cancer.” He added that “[b]efore, you died from AIDS, so you didn’t have time to develop cancer. … The unusual observation is the cancers are occurring at a much younger age.”

Although researchers do not know the exact reasons for the increased risk of developing some cancers, there are several theories as to why HIV-positive people are more susceptible, such as the increased life expectancy due to antiretroviral drugs; weakened immune systems related to the virus or the effects of antiretrovirals; and the likelihood of increased high-risk behaviors in people living with HIV. The Sun reports that a well-known researcher “wonders” if antiretrovirals could be a carcinogen. In addition, many cancers found in people living with HIV are known to be caused by viruses, such as anal, head, neck and cervical cancers — which have been linked to the human papillomavirus — and liver cancer, which has been linked to hepatitis. Mark Wainberg, director of the McGill University AIDS Center in Montreal, said, “There’s a real concern about all these cancers and what they portend. Obviously, we don’t want an epidemic of cancers in long-term HIV-infected people.”
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