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Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib – a CDK 4 and 6 Inhibitor – in Advanced Breast Cancer

On October 8, 2015 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer (Press release, Eli Lilly, OCT 8, 2015, View Source [SID:1234507665]).

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This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.

According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

"If caught before it spreads, patients can survive breast cancer. However, for the nearly 10 percent of patients who are initially diagnosed at stage IV,1 and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease,1 there remains an urgent need for effective therapy options," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "We are pleased that the FDA has designated abemaciclib as a breakthrough therapy for patients with advanced breast cancer and Lilly will work closely with the FDA in this process to expedite its development and review."

Lilly has an active clinical development program studying abemaciclib in breast cancer. MONARCH 1 is a Phase II trial evaluating the use of abemaciclib as monotherapy in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two Phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. each year, nearly 232,000 new cases of invasive breast cancer will be diagnosed and about 40,000 women will die from breast cancer.3 Of all diagnosed breast cancer cases in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.1 Metastatic breast cancer is considered incurable, but is generally treatable.

About Abemaciclib
Cyclin-dependent kinases play a key role in regulating cell cycle progression. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and 6. Lilly’s abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6, the results from the cell-free enzymatic assays have shown that it was most active against Cyclin D 1 and CDK 4. Results from preclinical and early-stage clinical studies support the further evaluation of abemaciclib for the treatment of human cancers – including breast cancer and lung cancer – in which aberrant CDK 4 and 6 pathways enhance cancer cell growth. Abemaciclib has now entered into Phase III development with two trials in HR+ breast cancer patients, as well as a Phase III trial in lung cancer.

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]).

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.

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]).

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.

Myriad Genetics and Tufts Health Plan Sign Agreement to Cover Prolaris(R) for Members With Localized Prostate Cancer

On October 7, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that it has signed a three-year contract with Tufts Health Plan through which the plan will provide coverage of Prolaris for members diagnosed with localized prostate cancer (Press release, Myriad Genetics, OCT 7, 2015, View Source [SID:1234507661]). Prolaris is the first and only biopsy test validated against prostate cancer specific mortality.

Tufts Health Plan is a leading health plan in the Northeast with more than one million members. Tufts Health Plan’s members will benefit from this agreement, which is designed to drive optimal treatment because men can confidently pursue active surveillance for tumors identified as being less aggressive with Myriad’s extensively validated Prolaris combined score. Recent data show that many men realize no benefit from interventional treatment, and many suffer needlessly from the side effects associated with radical prostatectomy and radiation.

"Myriad is excited to offer Prolaris testing to Tufts Health Plan’s members. We believe it will help to improve patient care and lower healthcare costs," said Nicole Lambert, general manager, Urology Business Unit, Myriad Genetic Laboratories. "The Prolaris test has been validated in multiple clinical studies and provides substantially stronger prognostic power than standard pathology. The Prolaris test enables physicians to confidently tailor treatment plans for their patients."

About Prolaris

Prolaris is a prognostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris is the only test that provides insight into meaningful oncologic endpoints by predicting 10-year prostate cancer-specific mortality, thereby guiding medical management. For more information visit: www.prolaris.com.

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]).

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."