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Varian Medical Systems Receives CE Mark for its Latest ProBeam® Proton Therapy System

On October 12, 2015 Varian Medical Systems (NYSE: VAR) reported it has received CE Mark for its latest ProBeam proton therapy system (Press release, InfiMed, OCT 12, 2015, View Source [SID:1234507695]). The CE Mark allows Varian to begin installation of the newest version of its ProBeam system in the European Union.

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Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects are reduced because proton beams can be controlled so that they deposit their energy within the tumor site rather than passing all the way through the patient. Especially in pediatric patients, the risk of developing a new, radiation-induced cancer later in life may be reduced.

Varian’s ProBeam system with Dynamic Peak scanning gives clinicians the ability to deliver the dose precisely in order to minimize dose to healthy tissue. It is uniquely capable of high-speed intensity modulated proton therapy (IMPT), the most precise form of proton therapy available, enabling modulation of the dose on a spot-by-spot, layer by layer basis throughout the treatment area. Irradiations from multiple angles are combined in an optimal manner to improve control of dose distributions. Scanning beam technology also eliminates the time-consuming need to manually insert separate shaping accessories for each beam angle in order to match the beam to the shape of the tumor.

High resolution images are available in the Varian newsroom at the following URL: View Source

Roche Wins the first HPV Primary Screening Tender in Europe

On October 12, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has been awarded a 5-year contract by the National Institute for Public Health and the Environment (RIVM) in the Netherlands for implementation of the cobas HPV Test as the first-line, primary screening test in the national cervical cancer screening program (Press release, Hoffmann-La Roche , OCT 12, 2015, View Source [SID:1234507693]). The decision concludes an extensive public tender process in which diagnostic providers were assessed on their ability to meet performance, quality and pricing criteria. The new national HPV based screening program is expected to start in the second half of 2016.

The Netherlands is expected to be the first country in the world with an organized cervical screening program to fully transition from the Pap test to primary HPV screening. Using HPV as the primary test is based on the overwhelming scientific evidence that it offers significant improvement over more traditional Pap cytology screening due to its ability to detect more pre-cancerous disease.
"The movement towards a national HPV screening program will lead to a more efficient and effective use of resources and, most importantly, fewer women will develop cervical cancer." said Dr. R.L.M. Bekkers, Gynecologist/Gynecologic Oncologist, Radboud University Medical Centre. Nijmegen. "Selecting the appropriate HPV test is a crucial first step for the success of this program."
The new Dutch cervical screening program with HPV includes a longer interval between routine screening visits as well as an option for women to self-collect their screening samples. To meet the needs of these program requirements, only HPV tests that utilize DNA PCR-based technology were considered for the tender.

"The cobas HPV Test was selected by the RIVM because it is supported by all the necessary evidence and data", said Roland Diggelmann, Chief Operating Officer of Roche Diagnostics. "We believe countries around the world will be looking toward the Netherlands as a potential model for how to best implement HPV primary screening to prevent cervical cancer. We are excited to have been chosen as their partner."

About the cobas HPV Test and cobas 4800 System from Roche Molecular Systems
Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample. In April 2014, the FDA approved the cobas HPV Test as a first-line primary screening test for cervical cancer in women 25 and older. It is now the only assay approved for the following indications: ASC-US reflex, co-testing, and primary screening.

The test is performed on the cobas 4800 System, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas 4800 CT/NG Test (chlamydia/gonorrhea), cobas Cdiff Test, cobas MRSA/SA Test, cobas HSV1 and 2 Test, and the cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test and cobas KRAS Mutation Test.

Phase 2 Dosimetry Data for Progenics’ AZEDRA Presented at EANM Congress 2015

On October 12, 2015 Progenics Pharmaceuticals, Inc., (Nasdaq:PGNX) reported that data from its Phase 2 study of Azedra for the treatment of ultra-orphan indications pheochromocytoma and paraganglioma were highlighted during an oral presentation at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany (Press release, Progenics Pharmaceuticals, OCT 12, 2015, View Source [SID:1234507697]).

Daniel Pryma, M.D., Associate Professor of Radiology and Radiation Oncology, Clinical Director of Nuclear Medicine and Molecular Imaging, University of Pennsylvania Perelman School of Medicine presented preliminary dosimetry data from the Phase 2 study in patients with iobenguane-avid metastatic and/or recurrent pheochromocytoma/paraganglioma. The study was designed to evaluate the efficacy and safety of two therapeutic doses of Azedra given 3 months apart, with dosimetric evaluation prior to the first therapeutic dose to ascertain avidity and tissue distribution. 44 patients had received a dosimetry dose before Molecular Insight suspended patient enrollment due to lack of funding.

"Prospective treatment planning via dosimetric evaluation for high-dose therapy is a critical component of radio-therapeutic development, serving as a safety check-point from which we can estimate the potential risk to critical organs," said Dr. Pryma. "This allows for dose adjustment for each individual if necessary, enhancing the safety profile of Azedra in this setting."

In this study, 44 patients underwent dosimetric evaluation, of which 41 (93.2%) demonstrated tumor avidity. 38 (86.4%) were eligible to receive up to 37 GBq based on dosimetry, while 6 (13.6%) required dose reduction based on pre-specified limits for the kidneys, liver, and lungs. Azedra was generally well tolerated with gastrointestinal and hematologic toxicity most frequently reported.

Dr. Pryma also presented updated preliminary long-term survival data from the first 41 patients dosed before enrollment in the trial was suspended in 2010. Seven of those patients had received one and 34 had received two therapeutic doses of Azedra. The study’s primary endpoint, a reduction of all anti-hypertensive medications for at least 50% and for at least six months, was achieved by 31.7% of patients. As of April 2015, the 34 patients receiving two therapeutic doses of Azedra had a median survival of 48.5 months.

About Azedra

Azedra is a radio-therapeutic with FDA Fast Track status currently being studied in a phase 2 registrational trial under a SPA with the FDA using a surrogate marker as registrational endpoint. In addition to potentially treating pheochromocytoma and paraganglioma, Azedra may also have utility in treating neuroblastoma and other neuroendocrine tumors. Clinical trials for Azedra have not been completed and regulatory approvals for Azedra remain subject to the successful completion of all required studies.

About Pheochromocytoma and Paraganglioma

Pheochromocytomas and paragangliomas are rare neuroendocrine tumors that arise from cells of the sympathetic nervous system. When pheochromocytomas are located outside the adrenal glands, they are called paragangliomas. Standard treatment options for these tumors include surgery, palliative therapy and symptom management. Malignant and recurrent pheochromocytomas and paragangliomas may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.

LabCorp to Offer New PD-L1 Test for Bristol-Myers Squibb’s OPDIVO® Following Collaboration in Clinical Trial

On October 12, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expanded approval of Bristol-Myers Squibb Company’s (BMS) OPDIVO (nivolumab) for the treatment of all appropriate patients with previously-treated non-small cell lung cancer (NSCLC) (Press release, LabCorp, OCT 12, 2015, View Source [SID:1234507696]). The PD-L1 IHC 28-8 pharmDx assay was developed by Dako, an Agilent Technologies company. The assay was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO demonstrated superior overall survival compared to chemotherapy in patients with previously treated metastatic non-squamous NSCLC. This approval expands the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. The test, although not required for OPDIVO, is a new tool that provides physicians with information on the potential survival benefit of treatment with OPDIVO.

"The launch of this innovative assay reinforces the importance of the LabCorp-Covance combination," said David P. King, Chairman and Chief Executive Officer of LabCorp. "Our central laboratory was the sole provider of testing for PD-L1 expression in the CheckMate-057 trial, which trial was the basis for regulatory approval, and LabCorp is one of the first laboratory providers of the PD-L1 IHC 28-8 pharmDx assay. We remain committed to our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic information."

"LabCorp’s support for CheckMate-057, a pivotal phase 3 registration trial evaluating survival benefit compared to chemotherapy, was an important contribution to OPDIVO’s clinical development program," said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. "We are very pleased with LabCorp’s seamless role supporting clinical development and regulatory approval of this new assay which can provide additional information to physicians."

"LabCorp’s support of a variety of BMS clinical trials involving OPDIVO gives us experience that no other lab has in performing and interpreting the results of this important complementary diagnostic assay," stated Steve Anderson, Chief Scientific Officer of Covance. "The availability of this test in support of an important new therapy reflects how our combined capabilities in drug development and diagnostics will support improved patient outcomes and reduced healthcare costs by delivering world class diagnostics and bringing innovative new medicines to patients."

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the U.S. and is the second most commonly diagnosed cancer, with an estimated 221,200 new cases diagnosed in 2015. Approximately 85-90% of patients with lung cancer are diagnosed with either squamous or non-squamous NSCLC, and a majority of these patients present with advanced stage disease at their initial diagnosis. For more information on the PD-L1 IHC 28-8 pharmDx, contact LabCorp’s Center for Molecular Biology and Pathology customer service line at (800) 345-4363.

Celsion Announces Impressive Preclinical Data for its GEN-1 IL-12 Immunotherapy in Combination with Avastin® and Doxil® for Ovarian Cancer

On October 12, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported data from a large preclinical study of the Company’s GEN-1 IL-12 immunotherapy in combination with Avastin and Doxil for the treatment of ovarian cancer (Press release, Celsion, OCT 12, 2015, View Source [SID:1234507690]). Results from the comprehensive studies confirmed remarkable initial GEN-1 + Avastin findings and show convincingly that GEN-1 when combined with Avastin and Doxil, standard of care for platinum resistant patients, demonstrated a greater than 98% reduction in tumor burden when compared to the untreated control group. The findings represent a statistically significant reduction in tumor burden and disease progression when compared to the combination of Avastin and Doxil in a SKOV3 human cell line implanted into immunocompromised (nude) mice.

"The immune stimulating nature of GEN-1 in combination with Avastin and Doxil makes for an ideal therapy, bolstering the anti-cancer effect beyond what has been observed when used alone," said Nicholas Borys, M.D., senior vice president and chief medical officer of Celsion. "Results from this study are highly encouraging and suggest that when these therapies are combined, they offer the potential to significantly reduce tumor burden and disease progression in this highly aggressive cancer in patients who have failed first line platinum-based therapies."

The study was designed to evaluate in a mouse model of disseminated ovarian cancer, the efficacy of a combined treatment regimen that consisted of weekly administrations of GEN-1 with therapeutically relevant doses of Doxil and Avastin. In the study, the combination of GEN-1 with Avastin and Doxil demonstrated a robust anti-tumor advantage compared to untreated animals as well as a statistically significant improvement over the combination of Avastin and Doxil.

Analysis of serum chemistry and hematology suggested no overt toxicities associated with the combined treatments. The preclinical data are consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties in addition to its well-characterized immunomodulatory activities.

GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1 has already demonstrated encouraging safety and efficacy clinical data in combination with PEGylated doxorubicin (Doxil) in patients with platinum-resistant ovarian cancer, with a clinical response rate (CR+PD+SD) of 86% at the highest GEN-1 dose cohort. GEN-1 has also produced encouraging data in combination with Avastin alone in earlier preclinical studies in a model of ovarian cancer, leading to a significant reduction in tumor burden and disease progression. Additionally, the data show that GEN-1 treatment alone resulted in anti-tumor activity that was as good as or better than Avastin treatment alone.

"The biology of GEN-1 continues to demonstrate a strong anti-tumor effect when combined with Avastin and Doxil, two of the most widely used cancer therapies," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "In addition to evaluating GEN-1 in first-line ovarian cancers, with Avastin’s recent approval for platinum resistant ovarian cancer patients, we now have an opportunity to study how our IL-12 immunotherapy may work in a clinical setting with Avastin, one of the most widely used cancer treatments with 2014 revenues of over $7 billion, to improve efficacy while enhancing tolerability. Confirmation of our initial findings now provides substantial evidence for a clinical program that includes Doxil and Avastin. We look forward to completing enrollment of the OVATION Study, next year, followed by the launch of this combination trial later in 2016."

The Company is currently enrolling patients in the OVATION Study, a Phase 1b dose escalating trial combining GEN-1 with neo-adjuvant therapies in newly diagnosed ovarian cancer patients which will provide a starting dose for the follow-on Phase 1/2 study combining GEN-1 with Avastin and Doxil. The Phase 1/2 combination trial is expected to begin in mid-2016.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer. GEN-1 has also demonstrated preclinical activity in glioblastoma multiforme (brain cancer) and the Company plans to initiate a Phase I study in this indication in the second half of 2015.