PharmaMar announced today that Ortho Biotech Products, L.P. has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL® (pegylated liposomal doxorubicin) for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL® will provide a new, non-platinum treatment option for these patients in the United States.

The submission of trabectedin dossier to the FDA by Ortho Biotech Products, LP entails a milestone payment to PharmaMar.

The application follows the completion of a multicenter, randomized Phase III study, ET743-OVA-301, one of the largest studies conducted in ROC, comparing the combination of trabectedin and DOXIL to DOXIL alone in 672 patients. The study showed that patients treated with the combination treatment had a statistically significant improvement in the primary endpoint of progression-free survival (PFS, or the length of time during and after treatment in which the disease does not progress) compared to patients treated with DOXIL alone.
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GenVec, Inc. (Nasdaq:GNVC) announced today top-line results of an interim analysis from its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade™ (PACT) in patients with locally advanced pancreatic cancer. This interim analysis of overall survival, conducted after the 92nd death (one-third of total expected events), was designed to determine whether the study should continue and took place in the time frame originally estimated.

Interim data demonstrated an approximately 25% lower risk of death in the TNFerade plus standard of care (SOC) arm relative to the SOC alone (Hazard Ratio= 0.753; 95% Confidence Interval [0.494-1.15]). An independent Data Safety Monitoring Board reviewed the interim analysis data and recommended the trial continue as planned.

Kaplan-Meier analysis of data, based on this interim analysis, demonstrated that overall survival at 12 months was 39.9% in the TNFerade plus SOC arm versus 22.5% in the SOC arm. Overall survival at 18 months was 30.5% in the TNFerade plus SOC arm versus 11.3% in the SOC arm. At 24 months, overall survival was 10.6% in the TNFerade plus SOC arm versus 11.3% in the SOC arm. Median survival was 9.9 months in both arms of the trial.

“Successfully passing this milestone in the PACT trial represents an important step forward in the clinical development of TNFerade,” stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. Thornton continued, “We believe these data are encouraging and justify moving forward with the trial. The continuation of the trial will allow the data to mature and provide for future analyses. We currently estimate we will reach the required number of events needed to conduct the next analysis of data in the PACT study in late 2009.”
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ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that its disease-directed randomized Phase 2 clinical trial of IMC-A12 in patients with previously treated HER2-expressing locally advanced or metastatic breast cancer has commenced patient enrollment. IMC-A12 is ImClone’s fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.

The primary objective of this Phase 2 study is to evaluate the antitumor activity of the combination of capecitabine and lapatinib with and without IMC-A12 in patients with HER2-expressing Stages IIIB, IIIC, or IV breast cancer that has progressed on trastuzumab-containing treatment. This study is being conducted by the North Central Cancer Treatment Group (NCCTG), a national clinical research group sponsored by the National Cancer Institute (NCI). NCCTG is comprised of a network of more than 1,000 community-based cancer treatment clinics in the United States, Canada and Mexico that work with Mayo Clinic to conduct clinical studies for advancing cancer treatment. Other Cooperative Groups are assisting NCCTG to recruit patients, via the CTSU (NCI’s CANcer Therapy Study Unit). This study is one of at least 10 Phase 1 and 2 clinical trials of IMC-A12 sponsored by the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), NCI. ImClone announced the selection of these proposals by NCI in September 2007.

“This study of IMC-A12 is a rationally designed study based on preclinical evidence suggesting that there are interactions between the HER2 and IGF-IR that may be exploited to improve treatment outcome for women with HER2-expressing breast cancer,” said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. “The NCCTG is seeking to determine if the anticancer activity of the combination with lapatinib and capecitabine, which is an approved treatment for women with HER2-expressing breast cancer that is no longer responsive to trastuzumab, can be improved by the addition of IMC-A12.”

This Phase 2 study of IMC-A12 will enroll approximately 154 patients at more than 140 sites across the U.S. Patients will be randomized to receive treatment with either capecitabine and lapatinib (one-third of the patients) or the same treatment plus IMC-A12 (two-thirds of the patients). Treatment in both arms will be continued as long as potential benefit is shown. The primary endpoint of the study is progression-free survival.
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Bovie Medical Corporation (the “Company”) (NYSE Alternext US: BVX), a manufacturer and marketer of electrosurgical products, today announced the Company received 510(k) clearance from the Food and Drug Administration (FDA) to market its SEER tissue resection device intended for initial use in liver oncology surgery. The SEER device uses conductive sintered steel as an electrode for radio frequency (RF) for cutting and coagulation.
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Olivier Delattre’s team (Inserm Unit 830 “Genetics and Biology of Cancer”) of the Institut Curie reveal in an article in the 16 October issue of Nature that alteration of the ALK gene is closely associated with the most frequent solid extracerebral tumor in children neuroblastoma. By studying the familial forms of this tumor, the researchers also conclude that ALK is a gene that predisposes to neuroblastoma. This discovery may allow the development of new treatments in neuroblastomas. It may also enable the identification in at-risk families of children who carry an altered ALK gene, so that they can be offered regular checkups. At present, over half of children diagnosed with neuroblastoma and metastases still die of their disease.

Neuroblastoma is the most frequent solid extracerebral tumor in young children. Some 50% of children affected boys and girls alike are under two years of age. In France, there are about 150 new cases every year, and one quarter of these are treated at the Institut Curie, a reference center recognized worldwide for its neuroblastoma research and treatment.
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Ortho Biotech Products, L.P. announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection)for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL will provide a new, non-platinum treatment option for these patients in the United States.

The application follows the completion of a multicenter, randomized Phase III study, ET743-OVA-301, one of the largest studies conducted in ROC, comparing the combination of trabectedin and DOXIL to DOXIL alone in 672 patients. The study showed that patients treated with the combination treatment had a statistically significant improvement in the primary endpoint of progression-free survival (PFS, or the length of time during and after treatment in which the disease does not progress) compared to patients treated with DOXIL alone.

“This is a significant milestone in the development of trabectedin, an agent with a novel mechanism of action that holds promise for patients with relapsed ovarian cancer,” said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. “We are confident in the strength of the data supporting the application and look forward to working with the FDA throughout the regulatory review process.”

Relapsed ovarian cancer refers to epithelial carcinoma of the ovary that recurs after treatment. According to the National Cancer Institute (NCI), it is estimated that 21,650 women will be diagnosed with, and 15,520 women will die from ovarian cancer in the U.S. in 2008.

Trabectedin is being developed under a license from PharmaMar, and DOXIL is marketed by Ortho Biotech Products, L.P. in the U.S.

About the ET743-OVA-301 Study

Patients were enrolled at 124 centers in 21 countries. Per the study protocol, the data were evaluated by a blinded, independent radiology review and a blinded, independent oncology review. The trabectedin/DOXIL combination demonstrated a statistically significant improvement in PFS compared to DOXIL alone (median PFS 7.3 versus 5.8 months, respectively) and a statistically significant reduction of 21% in the risk of progression or death during the observation period in the independent review of patients with radiologically measurable disease (HR=0.79, 95% CI (0.65;0.96), p=0.0190). This result is consistent with the results of the independent oncology review that takes into account clinical as well as imaging data in the assessment of progression. In this review, there was a 28% risk reduction for disease progression or death with the trabectedin/DOXIL combination (HR=0.72, 95% CI (0.60; 0.88), p=0.0008).

Secondary endpoints included response rate, overall survival, and safety. A statistically significant increase in response rate was seen with the trabectedin and DOXIL combination (28%) compared to DOXIL alone (19%), as measured by the independent radiology review. A final protocol-specified survival analysis is planned after the occurrence of 520 events. The safety profile in the study was consistent with previous experience with trabectedin and DOXIL.

The most common adverse reactions (greater than or equal to 20%) for the trabectedin/DOXIL combination compared to DOXIL alone, respectively, were:

– Hematological reactions including neutropenia (77% versus 38%, with febrile neutropenia occurring in 8% of the cases and sepsis in 1% of the cases), leucopenia (48% versus 26%), anemia (48% versus 25%) and thrombocytopenia (36% versus 8%);
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For breast cancer patients who underwent a mastectomy who undergo radiation therapy after immediate breast reconstruction, autologous tissue reconstruction provides fewer long-term complications and better cosmetic results than tissue expander and implant reconstruction, according to a study in the November issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of the American Society for Therapeutic Radiology and Oncology.

After undergoing a mastectomy (surgical removal of the breast), many women choose to have a breast reconstruction procedure performed immediately to better cope with the psychological and esthetic side effects of the surgery. However, the reconstruction can complicate radiation therapy treatments and sometimes radiation can negatively affect the outcome of reconstruction and increase the risk of long-term complications.
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Gefitnib is as effective a second-line treatment as docetaxel for patients with non-small cell* lung cancer. The INTEREST study, published in an Article in this week’s edition of The Lancet, thus establishes gefitinib as a valid treatment option for people with this condition. The study was written by Dr Edward Kim, M. D. Anderson Cancer Center, Houston, Texas, USA and colleagues.
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Scientists have new insight into the response of human skin to radiation and what drives the most aggressive and deadly form of skin cancer. The research, published by Cell Press in the November 21st issue of the journal Molecular Cell, may be useful in the design of new strategies for prevention of malignant melanoma.
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A team of researchers at Duke University Medical Center and the Université catholique de Louvain (UCL) has found that lactic acid is an important energy source for tumor cells. In further experiments, they discovered a new way to destroy the most hard-to-kill, dangerous tumor cells by preventing them from delivering lactic acid.

“We have known for more than 50 years that low-oxygen, or hypoxic, cells cause resistance to radiation therapy,” said senior co-author Mark Dewhirst, DVM, Ph.D., professor of radiation oncology and pathology at Duke. “Over the past 10 years, scientists have found that hypoxic cells are also more aggressive and hard to treat with chemotherapy. The work we have done presents an entirely new way for us to go after them.”

Many tumors have cells that burn fuel for activities in different ways. Tumor cells near blood vessels have adequate oxygen sources and can either burn glucose like normal cells, or lactic acid (lactate). Tumor cells further from vessels are hypoxic and inefficiently burn a lot of glucose to keep going. In turn, they produce lactate as a waste product.
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