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Leading Cancer Clinic in Taiwan Replaces Paper Charts with An All-Electronic Clinical Process And Enhanced Patient Safety Features

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."

8-K – Current report

On July 9, 2015 Epizyme reported that it has amended and restated its agreement with Celgene Corporation to extend the research collaboration between the two companies for at least three additional years (Filing, 8-K, Epizyme, JUL 9, 2015, View Source [SID:1234506203]). Under the collaboration, Celgene will have the option to license histone methyltransferase (HMT) inhibitors being developed by Epizyme against three predefined targets.

Under the terms of the revised agreement:
• Epizyme will receive a $10 million extension fee from Celgene in return for an option to individually license global rights for two of the targets and ex-US rights for the third target.
• Celgene may exercise its option with respect to each of the targets at the time of the IND filing for an additional pre-specified license payment.
• Epizyme will be responsible for leading and funding development for each target candidate through phase 1 clinical trials.
• Following the completion of phase 1, if Celgene chooses to continue its license for a specific target, it may do so by making an additional pre-specified payment.
• Epizyme may earn total potential milestones of up to $610 million on the three targets, including up to $75 million in development milestones and license fees, $365 million in regulatory milestones, and $170 million in sales milestones
• Epizyme also may earn a royalty of up to a low double-digit percentage on worldwide net sales for two of the product candidates, and on ex-US net sales for the third product candidate.
• Epizyme will retain global rights to the remainder of its pipeline, as Celgene’s option to license ex-US rights for any other preclinical programs will terminate.

In addition, Celgene will retain its ex-US license to, and the companies will continue their ongoing clinical collaboration on, pinometostat (EPZ-5676), a HMT inhibitor targeting DOT1L. Pinometostat is in phase 1 development for the treatment of patients with acute leukemia with alterations in the MLL gene (MLL-r).

"We believe that the extension of our agreement with Celgene will accelerate our goal of developing new therapies that have the potential to help many patients with epigenetically driven cancers," said Robert Gould, Ph.D., President and Chief Executive Officer, Epizyme. "Celgene is a leading company in oncology development and commercialization and we are pleased to continue our partnership on pinometostat and these three exciting novel targets."

The term of this agreement is based on specific development milestones, including the timing of IND filings and completion of phase 1 studies, but will extend for a minimum of three years. In addition, Celgene will no longer have the right of first negotiation on a business combination with Epizyme.

Financial Update
The Company also announced today that, based on its current operating plans, it projects that its cash and cash equivalents will be sufficient to fund operations through at least the end of the second quarter of 2017, prior to including any potential option exercise fees or future milestone payments. This new cash outlook reflects a significant reallocation of resources, implementation of cost savings initiatives, the additional capital provided from the Celgene extension fee payment and the partial exercise of the overallotment option in April from the Company’s March public financing.

"We have increased investment in tazemetostat development, both as a single agent and in future studies in combination with other agents," said Andrew Singer, Executive Vice President and Chief Financial Officer at Epizyme. "This required reprioritizing our pipeline development plans and reducing operating costs. We are excited about the updated data from our dose escalation and dose expansion studies presented at the International Congress on Malignant Lymphoma in Lugano, Switzerland on June 20. We look forward to presenting additional data at the European Society for Medical Oncology’s European Cancer Congress in Vienna, Austria on September 26."

About Tazemetostat (EPZ-6438)

Epizyme is developing tazemetostat for the treatment of non-Hodgkin lymphoma patients and patients with INI1-deficient solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 developed by Epizyme. In many human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Tazemetostat is the second HMT inhibitor to enter human clinical development (following Epizyme’s DOT1L inhibitor, pinometostat).

Epizyme is conducting a five-arm, multi-center international phase 2 clinical trial that will assess the safety and activity of tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma. A phase 1 dose escalation and dose expansion trial of tazemetostat is also ongoing, with additional data expected to be reported later in 2015. Additional information about this program, including clinical trial information, may be found here: View Source

About Pinometostat (EPZ-5676)

Epizyme is developing pinometostat, a small molecule inhibitor of DOT1L created with Epizyme’s proprietary product platform, for the treatment of patients with acute leukemia in which the MLL gene is rearranged due to a chromosomal translocation (MLL-r). Due to these rearrangements, DOT1L is misregulated, resulting in the increased expression of genes causing leukemia. Pinometostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-5676.

Epizyme believes that pinometostat was the first HMT inhibitor to enter human clinical development. Epizyme is currently conducting a two-stage Phase 1 study in adult MLL-r patients
and in May 2014, initiated a Phase 1b study of pinometostat in pediatric patients with rearrangements of the MLL gene. The adult dose escalation cohorts have completed enrollment, and an adult MLL-r dose expansion cohort is now enrolling patients. Additional information about these ongoing Phase 1 studies can be found here: View Source

Pinometostat has been granted orphan drug designation for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) by the Food and Drug Administration in the U.S. and by the European Commission in Europe.

Epizyme retains all U.S. rights to pinometostat and has granted Celgene an exclusive license to pinometostat outside of the U.S.

Lilly Statement on FDA Advisory Committee Review of Necitumumab

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]).

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.

Mylan Launches First Generic Targretin® Capsules

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)

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.

DelMar Pharmaceuticals to Present Updated Phase I/II Clinical Data on VAL-083 in the Treatment of Refractory Glioblastoma Multiforme at GBM2015: 2nd International Symposium on Clinical and Basic Investigation in Glioblastoma

On July 9, 2015 DelMar Pharmaceuticals reported that the Company will be presenting updated clinical data on its lead product candidate, VAL-083, from its Phase I/II clinical trial in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer (Press release, DelMar Pharmaceuticals, JUL 9, 2015, View Source [SID:1234506194]).

DelMar’s abstract entitled, "Update on Phase 1/2 study of VAL-083 (dianhydrogalactitol) in patients with recurrent malignant glioma," will be presented during a poster session at GBM2015, II International Symposium on Clinical and Basic Investigation in Glioblastoma, being held September 9 – 12, 2015, in Toledo, Spain.

In spite of recent advances in cancer care, GBM continues to be the most common and malignant primary brain tumor in adults carrying a dismal prognosis with less than 15 months median survival. The symposium is designed with a focus on clinical and basic research in this devastating disease.

DelMar recently presented interim data from the trial at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar’s multicenter Phase I/II clinical study with VAL-083 is ongoing in patients with recurrent GBM. Eligible GBM patients must have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). (ClinicalTrials.gov Identifier NCT01478178). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).