8-K – Current report

On October 7, 2015 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, and its subsidiary OncoCyte Corporation ("OncoCyte"), reported that OncoCyte has filed a Form 10 Registration Statement with the Securities and Exchange Commission ("SEC") in connection with BioTime’s planned distribution OncoCyte common stock to holders of BioTime common shares, on a pro rata basis (Filing, 8-K, BioTime, OCT 7, 2015, View Source [SID:1234507666]).

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The filing represents an important milestone in separating BioTime’s therapeutics and cancer diagnostics businesses. BioTime expects that the distribution will provide OncoCyte with greater access to capital markets in order to obtain its own financing for its operations, separately from BioTime financings. The distribution will also allow BioTime and OncoCyte to each focus on its own strategic priorities relating to its own management, capital structure, business model, and financial goals. The distribution may also provide enhanced liquidity to holders of BioTime common shares, who after the distribution will hold two separate publicly traded securities that they may choose to monetize or retain.

BioTime continues to believe in the opportunity for cancer diagnostics and expects to continue to own a majority of the outstanding common stock in OncoCyte immediately after the distribution. The "record date" for determining BioTime shareholders entitled to receive OncoCyte common stock in the planned distribution, and the date on which the distribution will occur, have not yet been determined. However, BioTime’s plan is to effect the distribution to BioTime shareholders in late 2015, subject to certain conditions.

OncoCyte is engaged in the development of new "liquid biopsy" diagnostic tests for cancer based on analyzing patient blood or urine samples for specific gene or protein markers indicative of the presence of particular types of cancer. OncoCyte is presently developing diagnostic tests for lung cancer, breast cancer and bladder cancer.

More information about OncoCyte and the planned shared distribution can be found in the Information Statement filed as an exhibit to OncoCyte’s Form 10 Registration Statement, which is available on the "Latest News" page of OncoCyte’s website: www.oncocyte.com and the website maintained by the SEC at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any OncoCyte securities. The distribution of OncoCyte common stock by BioTime will be made only in those states and other jurisdictions where permitted or not prohibited by law.

Sunesis Announces Anticipated Submission of European Marketing Authorization Application for Vosaroxin in AML Before Year End

On October 7, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the company intends to submit a Marketing Authorization Application (MAA) for vosaroxin as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency (EMA) by the end of 2015 (Press release, Sunesis, OCT 7, 2015, View Source;p=RssLanding&cat=news&id=2095135 [SID:1234507667]).

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The company recently announced that it met separately with the Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands) assigned to provide advice and guidance to the company through the MAA process. Based on these discussions, the company is proceeding with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company’s pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML.

"The filing of an MAA for vosaroxin in Europe by year end is our top corporate priority. As for the U.S., we are refining a plan to find a timely path towards market," said Daniel Swisher, Chief Executive Officer of Sunesis. "With these efforts underway, we also expect to achieve meaningful progress in our kinase inhibitor pipeline, including data presentations at the upcoming November AACR (Free AACR Whitepaper)-NCI-EORTC Conference in Boston. Among those being highlighted at the conference is our second generation, differentiated BTK program, SNS-062."

Sunesis also announced today changes to the executive management team. Chief Medical Officer, Adam R. Craig will step down from his role at the end of the year to pursue other opportunities. Dr. Craig will remain available to the company on an advisory basis throughout the regulatory process with the EMA. Also within the Development group, Jennifer A. Smith has been appointed Vice President of Biometrics, where her responsibilities include the statistical design of the company’s clinical trials as well as clinical data analyses and presentations, including those supporting ongoing regulatory filings. Dr. Smith joined Sunesis in 2012 from BiPar Sciences where she was Senior Director of Biometrics. Prior to BiPar, she served in similar roles at Geron, Pharmacyclics and Aviron.
Mr. Swisher added: "We thank Adam for his leadership and significant contributions at Sunesis as Chief Medical Officer and look forward to continuing to work with him as a valued advisor in 2016. We have begun a search to complement our experienced internal team with additional clinical development expertise."

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be approximately 20,830 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

Kite Pharma Commends Steven A. Rosenberg, M.D., Ph.D., on the Prestigious Medal of Honor Award From the American Cancer Society

On October 7, 2015 Kite Pharma, Inc. (Kite) (Nasdaq:KITE) reported that Steven A. Rosenberg, M.D., Ph.D., Chief of Surgery at the National Cancer Institute (NCI) and a special advisor to Kite, has received three significant awards for his achievements and career dedicated to advancing cancer research (Press release, Kite Pharma, OCT 7, 2015, View Source [SID:1234507657]). The American Cancer Society (ACS), the largest voluntary health organization in the United States, awarded Dr. Rosenberg its Medal of Honor for his pioneering leadership in cancer immunotherapy. The Medal of Honor is the ACS’ highest honor and was presented to Dr. Rosenberg at a ceremony held in Washington, DC, on September 30, 2015. Additional recent awards include:

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Dr. Rosenberg has been awarded the Samuel J. Heyman Service to America Medal for career achievement by the Partnership for Public Service. The "Sammies" are bestowed upon individuals to highlight excellence in the federal workforce and inspire other talented and dedicated individuals to go into public service. Dr. Rosenberg will receive his award during a gala and ceremony that is taking place tonight, October 7, in Washington, DC.

Susan G. Komen, the world’s largest breast cancer organization, awarded Dr. Rosenberg the Betty Ford Lifetime Achievement Award for his four decades of work in fighting cancer at the NCI. This award recognizes individuals who have committed their lives to engaging the public in the fight against breast cancer, advocating for meaningful change, and educating communities to support women and men facing the disease. Dr. Rosenberg was recognized during the Honoring the Promise gala, which took place in Washington, DC, on September 24, 2015.

In 2012, Kite partnered with Dr. Rosenberg and the NCI under a Cooperative Research and Development Agreement (CRADA) to further the research and development of multiple chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates for the treatment of advanced solid and hematological malignancies. Many of these product candidates are now being assessed in clinical trials and Kite has since exclusively licensed intellectual property related to certain of these product candidates.

"We have always appreciated the great honor of being able to advance cancer therapies with Steve and are thrilled that three of the most prominent awards in medicine and public service have been made in recognition of the pivotal role Steve has played in cancer care and research on the national stage," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "During his long and successful career, Steve’s insights time and again have had an astounding impact on the direction of cancer research. His contributions, including to the exciting field of cancer immunotherapy, have been immense, and we are elated for Steve to receive these awards."

Cancer Research UK invests £15 million to unite finest minds across UK to develop better treatments

On October 7, 2015 Cancer Research UK reported that it has invested £15 million to inspire collaborative cancer research between scientists across the UK through a new awards scheme launched today (Press release, Cancer Research UK, OCT 7, 2015, View Source [SID:1234507659]).

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"Effective partnerships are crucial for delivering the greatest science and boosting advancements in fighting cancer." – Dr David Scott

The Cancer Research UK Centres Network Accelerator Award is a new initiative which provides infrastructure support to research centres in order to encourage collaboration between different organisations and boost ‘bench to bedside’ science.

Four centres – Queens University Belfast (link is external), the University of Leicester (link is external), the Francis Crick Institute (link is external), and the University College London (link is external)– have each received a five-year grant.

Queens University Belfast* received £3.9 million to develop new pathology and image analysis techniques for solid tumours. This includes research to improve cancer diagnosis through tissue imaging, biomarker discovery, and clinical trials. The award will also invest in the next generation of scientists with a Clinical Fellowship programme in molecular pathology.

The University of Leicester** received £1.7 million to set up facilities to study structural biology among centres to improve drug development. The award will focus on research to translate the understanding of structural biology into drugs that could treat patients.

The Francis Crick Institute*** received £4.2 million to support more experimental cancer research and create Clinical Research Fellowships to help unite different research centres in London. This will help turn innovation in the laboratory into tangible benefits for patients – to save more lives from the disease in the future.

University College London**** received £5 million to help advance immunotherapy research – a field of cancer research which has shown promise for a long time and recently provided exciting breakthroughs in cancer treatments. The award will fund research to understand how patients develop immune responses – and why they stop responding to treatments. The award will also help scientists develop new therapies, and safe ways to give treatments.

Professor David Waugh, Director of the Centre for Cancer Research and Cell Biology at Queens University Belfast, said: "This award will allow us to accelerate the development of clinically-robust diagnostic tests that assist in personalizing cancer therapy. The network will help us set technology standards for this increasingly important and fast growing area of cancer research."

Professor Catrin Pritchard, science director at the Cancer Research UK Leicester Centre, said: "Personalised medicine is the future of cancer treatment, and by collaborating with centres across the UK, we look forward to accelerating research underpinning drug development."

Dr Richard Treisman, a research director at the Francis Crick Institute, said: "Thinking outside the box and collaborating across different disciplines and institutions is what we need to invigorate more innovative cancer research."

Professor Henning Walczak, scientific director of the Cancer Research UK – UCL Centre, said: "There has been great progress in the field of cancer immunotherapy and by collaborating with centres across London our Accelerator Network aims to bring successful cancer immunotherapies to more patients and to overcome some of the hurdles in this field."

Dr David Scott, Cancer Research UK’s director of science funding, said: "Effective partnerships are crucial for delivering the greatest science and boosting advancements in fighting cancer. We’re proud to invest in collaborative and innovative research across the UK with the new Centres Network Accelerator awards. It’s through working together and uniting expertise that we will do better research and save more lives."

Varian Announces U.S. Clearance and CE Mark for VitalBeam™ Package; Chirayu Medical College in Bhopal Acquires the New Platform for Advanced Radiotherapy

On October 7, 2015 Varian Medical Systems reported that the Chirayu Medical College and Hospital (CMCH) in Bhopal, India, is among the first cancer treatment centers around the world to acquire the new VitalBeam platform from Varian Medical Systems (NYSE: VAR), offering clinics a modular technology package for affordable, high-quality, high-throughput radiotherapy, and for expanding clinical capabilities over time (Press release, InfiMed, OCT 7, 2015, View Source [SID:1234507660]).

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The VitalBeam radiotherapy treatment platform from Varian Medical Systems
Varian recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as well as the CE Mark for the VitalBeam platform. In addition to the CMCH in India, treatment centers in the U.S. and Europe have now ordered the system, which incorporates many of the innovations Varian developed to enhance the precision, safety, and speed of treatment on its popular TrueBeam radiotherapy system.

The VitalBeam system at the CMCH will anchor a new radiotherapy department there, complementing existing medical oncology services. "We are looking to increase the capacity in our region for helping cancer patients with the most advanced treatments possible and we are making efforts to provide patients with the best available treatments in the world," said Ajay Goenka, M.D., owner of CMCH. "We chose VitalBeam because we wanted something with the advantages of the TrueBeam platform that would enable us to go beyond basic intensity-modulated radiotherapy."

"The VitalBeam system will enable us to complete image-guided treatments quickly—in as little as 2-4 minutes when using advanced capabilities like RapidArc—and to shape the radiation dose very precisely," added T. P. Sahoo, M.D., physician at the CMCH. "That will be good news for the cancer patients of our region."

According to Dr. Sahoo, the clinical team at the CMCH will use the VitalBeam system to treat patients with tumors in vital locations where toxicity to healthy tissues must be minimized. "I anticipate that we will use it curatively, to treat head and neck, brain, pancreatic, and other abdominal malignancies, because these are common cancers that can be addressed with advanced radiotherapy."

"Our goal, with this platform, was to help increase access to quality cancer care around the world," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "We are gratified to work with institutions like the Chirayu Medical College in bringing advanced, image-guided radiotherapy to more cancer patients."