On July 12, 2015 Varian Medical Systems reported the Koo Foundation Sun Yat-Sen Cancer Center (KF-SYSCC) has established an entirely paperless and filmless clinical process in radiation oncology, designed to enhance patient safety as well as operational efficiency (Press release, InfiMed, JUL 12, 2015, View Source [SID:1234506321]). Using the ARIA oncology information system from Varian Medical Systems (NYSE: VAR), the clinical team has automated essential tasks, built in safety-checks, and centralized patient information for easier access by staff members.

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ARIA combines a comprehensive, oncology-specific patient electronic medical record (EMR) with numerous tools for managing clinical, administrative and financial operations in multidisciplinary cancer care settings.

"We were using both Varian and Siemens information management software, but we standardized on Varian’s ARIA platform. Within three months we had removed all paper charts from the department," said Yeh-Chi Lo, Ph.D., chief of the Department of Medical Physics. "Varian and its local agent, Cooperative C.L. Enterprise Co., provided us with valuable assistance, helping us to configure the ARIA software to manage different types of treatment, and to reflect our preferences in terms of clinical work flow. The software is set up to interrupt the clinical workflow at critical junctures unless specific safety checks have been completed and documented."

"Conversion to an electronic process actually made our workflow more efficient, and potentially safer due to careful automation of essential steps," added Skye Hung-Chun Cheng M.D., chief of the Department of Radiation Oncology. "Our goal was to become a fully paperless and filmless department. ARIA has also enhanced the communication between our clinical team members."

The KF-SYSCC Radiation Therapy Department is a mixed-vendor environment, treating patients on three Varian linear accelerators including a TrueBeam system plus a Primus-M machine from Siemens.

Seven radiation oncologists working with nine medical physicists at the cancer center offer patients a broad range of advanced treatments, including intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), RapidArc radiotherapy, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy (SBRT). Clinicians use respiratory gating to compensate for breathing motion during treatments for lung or breast cancer.

The cancer center also manages high-dose-rate brachytherapy and seed implant procedures using the ARIA platform, resulting in one comprehensive database of patient information that can be mined for insights about trends and outcomes.

"The future of health care will center on the use of evidence-based protocols within a pay-for-performance framework," said Dr. Cheng. "Realizing that vision will rely on our ability to mine our clinical data–something that would not be feasible without a comprehensive EMR like ARIA."

"The Radiation Therapy Department of the Koo Foundation Sun Yat-Sen Cancer Center is the first department in Taiwan to use ARIA to establish a fully paperless clinical environment," said Zhang Xiao, Varian’s vice president and managing director of the greater China region. "Varian commends the clinical and management teams for being forward-looking thought leaders in the use of digital technology to improve the quality of cancer care."

On July 12, 2015 Provectus Pharmaceuticals reported studies presented at the European Society for Medical Oncology 17th World Congress on Gastrointestinal cancer, Barcelona, Spain,1-4 July, helped define the hepatocellular carcinoma and liver metastatic colorectal cancer patient populations in which established treatments work best and provided insights into emerging therapies (Press release, Provectus Pharmaceuticals, JUL 12, 2015, View Source [SID:1234506324]).Patients with hepatocellular carcinoma (HCC) have a poor prognosis with median survivals of 10 to 11 months despite use of sorafenib first line. Liver metastases develop in nearly 20% of patients with stage II and 50% of patients with stage III colorectal cancer and represent the major cause death in this disease. Unfortunately, radical surgical resection of liver metastases is only possible in 10 to 25% of patients with CRC confined to the liver. In most patients the number, localization and/or size of the liver metastases or poor hepatic reserve preclude resection. All this points to the unmet medical need for both HCC and metastatic liver cancer.

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The latest analysis of the GIDEON study, which set out to evaluate the safety of sorafenib in a real world population of HCC patients, showed improved outcomes for patients over 70 years compared to those under 70 years. The current subgroup analysis explored 278 patients from the Italian cohort of the main study, of whom 141 were older than 70 years and 133 younger.

Results showed that the median overall survival was 10 months in the younger age group versus 20 months in the older age group. Furthermore, elderly patients had a PFS of 6 months versus 4.1 months for younger patients; and elderly patients had a time to progression of 7.6 months versus 5 months for younger patients. The authors believe that younger patients have shorter overall survivals due to more advanced disease.

The latest sub-analysis from the SIRFLOX study showed patients with metastatic colorectal cancer (mCRC) that has spread only to the liver at study entry do better with selective internal radiation therapy (SIRT) than those with more widespread metastases.

With SIRT, a technique granted CE Mark approval in the EU in 2002 for unresectable liver tumours, yttrium-9-resin microspheres (Sirtex) are delivered to the liver via a hepatic artery injection. Key to the success of the procedure is occlusion of extra-hepatic vessels to prevent deposition of radioactive microspheres outside the liver. Since there have never been large randomized controlled trials for SIRT in combination with modern first-line standard of care chemotherapy the SIRFLOX study was initiated.

Data presented at ASCO (Free ASCO Whitepaper) 2015 failed to show overall progression free survival advantages for patients treated with mFOLFOX6 + SIRT compared to those treated with chemotherapy alone. The findings were attributed to the inclusion of 40% of patients with extra-hepatic metastatic disease in the analysis.

In the current sub-group analysis the investigators explored the 318 patients with metastases limited to the liver at the time they entered the study separately from the 212 patients with both liver and extra hepatic metastases at study entry.

Results showed that for those treated with metastases limited to the liver median PFS in the liver was 21.1 months for those treated with chemotherapy + SIRT compared to 12.4 months for those treated with chemotherapy alone (p=0.003, HR 0.64). "These new pre-planned sub-group findings for PFS in the liver should lead oncologists to consider adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy," said Guy van Hazel, the co-principal investigator of the SIRFLOX study, from the University of Western Australia, Perth.

Rose bengal solution as hepatocellular carcinoma treatment
According to one intriguing abstract study, a single injection with PV-10 led to the complete disappearance of HCC in one patient, and colorectal liver metastases in another. PV-10, a 10% solution of rose bengal used originally to stain necrotic tissue in the cornea, has been showing promise in melanoma. A phase 2 study, presented at ESMO (Free ESMO Whitepaper) last year, demonstrated that 50% of patients with stage III melanoma patients who had all their cutaneous lesions injected with PV-10 achieved a complete response.

For the current study two cohorts of patients, one with non-resectable HCC (n=6) and a second with other forms of cancer metastatic to the liver (n=7, three originally colorectal tumors, two nonsmall cell lung, two melanoma and one ovarian) underwent a single percutaneous injection of PV-10 guided by CT to one target lesion in the liver at least 1 cm in diameter.

From the analysis of the first five patients (who had six tumours injected) the investigators found that two patients showed no evidence of disease at more than 40 months follow-up according to RECIST and EASL criteria. The first patient was a 68 year old male with HCC (hepatitis B and cirrhosis) alive at 54 months follow-up with no evidence of disease; while the second patient was a 61-year-old male with metastatic CRC alive at 42 months follow-up with no evidence of disease.

"Having liver cancer patients alive at up to 54 months follow-up with no evidence of disease is remarkable. This is even more extraordinary when you consider these patients received just one or two intralesional injections," says Eric Wachter, the author of the abstract who co-developed PV-10.

As with melanoma, the mechanism of PV-10 in liver cancers is believed to be due to local chemoablative effects where the agents enters lysosomes causing tumor necrosis that can stimulate immunological effects.

Furthermore, melanoma patients injected with PV-10 have been shown to have increased T cells in peripheral blood, including CD8+, CD4+, CD3+ and NKT.

On July 9, 2015 Mylan reported the U.S. launch of Bexarotene 75mg Capsules, which is the generic version of Valeant’s Targretin Capsules (Press release, Mylan, JUL 9, 2015, View Source [SID:1234506195]). This product is indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy.(1)

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Mylan CEO Heather Bresch commented: "Mylan’s launch of the first and only generic Targretin is another example of our commitment to expand access to high quality, more affordable medicines. The launch also strengthens Mylan’s growing oncology franchise of more than 30 approved oncology treatments, and associated supportive care and diagnostic products in the U.S. We look forward to continue meeting patient, payor and provider needs in this space."

Bexarotene 75mg Capsules had U.S. sales of approximately $155.5 million for the 12 months ending March 31, 2015, according to IMS Health.

Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products and the company’s strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company’s business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; changes in third party relationships; uncertainties and matters beyond the control of management; and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
(1) Targretin Capsules are a member of the retinoid class of drugs that is associated with birth defects in humans. Targretin Capsules must not be administered to a pregnant woman.

On July 9, 2015 Cancer Research UK and Cancer Research Technology (CRT) reported they have reached an agreement with Monopar Therapeutics LLC, an emerging biopharmaceutical company focused on developing orphan oncology compounds*, to take forward Monopar’s experimental antibody treatment HuATN-658 into clinical trials in cancer patients with advanced solid tumours (Press release, Cancer Research Technology, JUL 9, 2015, View Source [SID1234523204]).

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HuATN-658 is an antibody that targets the cell surface protein uPAR, which is found in high levels in some of the most deadly cancers.

Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will finance and complete preclinical development of HuATN-658 and conduct a Phase 1 clinical trial in cancer patients. Although drug efficacy will be monitored, the trial’s main objective will be to evaluate the safety of the antibody.

The trial will be managed and run by the CDD through the Experimental Cancer Medicine Centre (ECMC) network, a UK-wide initiative funded by Cancer Research UK and the UK’s four Health Departments.

Upon completion of the clinical trial, Monopar has the right to acquire the clinical trial data. If Monopar declines the option, CRT may continue the development and commercialisation of HuATN-658 in exchange for a share to Monopar of any future revenues from the drug.

Dr Chandler D. Robinson, co-founder and CEO of Monopar Therapeutics, said: "While these are still the early days of the company, we have created a very strong team and development strategy.

"HuATN-658, our lead compound, was discovered by our chief scientific officer, Dr Andrew Mazar, one of the world’s experts on the uPAR pathway.

"The development partnership with Cancer Research UK allows Monopar to leverage a strong platform for the clinical advancement of this compound as it brings long established clinical, regulatory, and manufacturing expertise and resources that would be difficult for an emerging company to amass quickly."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said, "We’re excited to be working with Monopar Therapeutics to take this promising new treatment a step further on its journey towards the clinic. The collaboration forms part of our Clinical Development Partnerships scheme, which aims to help progress promising treatments from drug company pipelines and bring them into early phase trials sooner. Thanks to this, six new treatments are now in clinical trials that may otherwise never have moved beyond the lab."

On July 9, 2015 Eli Lilly reported the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) met today to discuss the data supporting Eli Lilly and Company’s necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) (Press release, Eli Lilly, JUL 9, 2015, View Source [SID:1234506198]).

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Squamous NSCLC is a devastating and difficult-to-treat form of lung cancer. The five-year survival rate for patients with metastatic disease is less than five percent.[1] Necitumumab in combination with gemcitabine and cisplatin is the first regimen to show a significant improvement in overall survival over chemotherapy alone, specifically in the first-line setting.

"We are encouraged by the Committee’s constructive discussion on the benefit-risk profile of necitumumab as few advances have been made over the past two decades in the first-line treatment of advanced squamous NSCLC, leaving a significant unmet medical need," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "We believe necitumumab with gemcitabine and cisplatin represents a meaningful advance in the search for a new first-line treatment option and look forward to working closely with the FDA as they continue their review."

The FDA is expected to make a decision on Lilly’s biologics license application for necitumumab later this year.

About Necitumumab
Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death.

About Squamous Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer, and accounts for about 85 percent of all lung cancer cases.[2] Squamous NSCLC, which represents about 30 percent of all people affected by NSCLC,[3] is a devastating, difficult-to-treat form of the disease. Patients face an imposing disease and symptom burden with very poor prognosis; the five-year survival rate for patients with metastatic disease is less than five percent.[4] Little progress has been made over the last two decades, particularly in the first-line setting, leaving a significant unmet medical need. In order to address the unique and complex needs of individual patients with advanced squamous NSCLC, more first-line treatment options are needed.