On December 1, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will present data from its most recent breast cancer diagnostic study during a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 7, 2017 (Press release, BioTime, DEC 1, 2017, View Source;p=RssLanding&cat=news&id=2319585 [SID1234522329]). The SABCS will take place at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 5-9, 2017.

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The data to be presented are from the Company’s NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer follow-on study. The data confirm the findings from OncoCyte’s previous breast cancer study, which were presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2016. In the earlier study, the 15-marker model resulted in an area under the curve (AUC) of 0.92 with a sensitivity of 90% and specificity of 76%. Given this level of accuracy, and subject to successful completion of further R&D and clinical studies, OncoCyte’s novel panel of serum protein biomarkers may become the foundation of a highly accurate, non-invasive breast cancer diagnostic test.

The AUC of a test is a measure that combines sensitivity and specificity to express its total accuracy, with 1.0 being perfect accuracy and 0.50 being a random result. Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant lumps or masses that are identified correctly by the test and specificity measuring the percentage of benign lumps or masses correctly identified.

"We look forward to reporting data from our breast cancer diagnostic development program at this prestigious conference," said William Annett, President and Chief Executive Officer. "The data from our breast cancer studies are compelling and we look forward to continuing to advance the development program in 2018. We believe our test would address a significant unmet need by reducing the number of unnecessary invasive breast biopsies and lowering the financial burden to the healthcare system."

The data from the NICE-BC study will be presented at SABCS 2017 by Philip McQuary, Ph.D., Director, Product Development, at OncoCyte.

Abstract Title: Assessment of an immune response panel of serum protein biomarkers for the non-invasive detection of breast cancer
Poster Session: 2 (P2-02-03)
Session Title: Detection/Diagnosis: Circulating Markers
Session Date: December 7, 2017
Session Time: 7:00 am CT – 9:00 am CT

The current standard of care for breast cancer diagnosis – annual or biannual mammogram screenings – does not meet the needs of large populations of women for whom mammography alone is not sufficient. These populations include women with dense breast tissue, genetic mutations (BRCA), a family history of breast cancer, or those who have suspicious mammogram screening results (BIRADs 3 or 4). The Company’s non-invasive liquid biopsy breast cancer diagnostic is intended to be a confirmatory, post-mammogram test that would address the needs of some of these populations, thereby reducing the number of patients subjected to invasive procedures.

According to published reports, there are about 39 million mammograms performed annually in the U.S., resulting in 1.6 million breast biopsies per year. Of these, only 260,000 (16%) result in a cancer diagnosis. The large number of suspicious findings in diagnostic mammograms leads to a significant amount of unnecessary invasive follow-up procedures. The financial burden to the healthcare system imposed by the follow-up testing of false-positive mammograms and breast cancer over-diagnosis is estimated to be $4 billion a year.

About Breast Cancer

Breast cancer is the second most common cancer among US women. Current screening guidelines set forth by the American Cancer Society recommend screening mammography for the early detection of breast cancer in women at average risk. Specifically, guidelines call for annual mammography for asymptomatic women age 45 to 54 and once every two years for women age 55 and older. Suspicious screening mammograms are generally followed up with a diagnostic mammogram and sometimes by an MRI (Magnetic Resonance Image) or an ultrasound. Ultimately, suspicious findings unresolved by imaging typically result in the recommendation of a breast biopsy.

On December 1, 2017 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported that it will participate in the Citi 2017 Global Healthcare Conference on Wednesday, December 6, 2017, in New York City (Press release, Medtronic, DEC 1, 2017, View Source;p=RssLanding&cat=news&id=2319639 [SID1234522334]).

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Geoff Martha, executive vice president and president of the Medtronic Restorative Therapies Group (RTG), will answer questions about the company beginning at 8:45 a.m. EST (7:45 a.m. CST).

A live audio webcast of the presentation will be available on December 6, 2017, by clicking on the Investor Events link at View Source, and an archive of the session will be available on the same webpage later in the day.

On December 1, 2017 Carrick Therapeutics, a biopharmaceutical company focusing on the innovative research and development of transformative oncology medicines, reported that the first patient has been dosed in the phase 1 clinical programme of CT7001 – an orally bio-available Cyclin-dependent Kinase 7 (CDK7) selective inhibitor, that has shown striking efficacy in multiple pre-clinical cancer models (Press release, Evotec, DEC 1, 2017, View Source [SID1234522324]).

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Elaine Sullivan, chief executive of Carrick Therapeutics, said:

"We are excited by the potential of CT7001 to make a major difference in cancer treatment, and intend to rapidly progress CT7001 through clinical development and bring this promising new medicine to patients as quickly as possible. This is a significant achievement for Carrick to take a pre-clinical candidate to first patient dosed in less than two years."

CDK7 inhibition has emerged as a promising strategy in a range of cancer indications. CDK7 acts as a master regulator of transcription, as well as a regulator of the cell cycle through phosphorylation of members of the CDK family. Inhibition of CDK7 suppresses the expression of key oncogenes such as c-Myc.

CT7001 was found to be effective in pre-clinical models of breast cancer, both hormone receptor positive and triple-negative, and transcriptionally driven cancers such as acute myeloid leukemia and small-cell lung cancer (SCLC). All these cancers continue to have major unmet medical need, for example, very little progress has been made for decades in the treatment of SCLC and triple-negative breast cancer (TNBC). Due to its differentiated mechanism, CT7001 is also predicted to be efficacious where resistance has developed to current therapies.

CT7001 originated from Cancer Research UK funded scientists at Imperial College London and was licensed to Carrick by the charity’s Commercial Partnerships Team. Rapid subsequent preclinical development by the company’s experienced research and development team has led to approval for the first-in-human Phase I study. Efficacy studies are planned to start in 2018.

Carrick Therapeutics was established with an initial funding round that saw it raise $95 million, and continues to build its portfolio through partnering. Significantly, whilst other companies bank on a single molecule or biological mechanism, Carrick will build a portfolio that targets multiple mechanisms that drive cancer. In close partnership with a network of clinicians and scientists in internationally leading research institutes and hospitals, the business will drive its portfolio of ground-breaking cancer therapies from laboratories to the clinic.

The funding of Carrick Therapeutics was co-led by ARCH Venture Partners and Woodford Investment Management, with participation from Cambridge Enterprise, Cambridge Innovation Capital, Evotec, GV (formerly Google Ventures), and Lightstone Ventures.

On November 30, 2017 Pfizer Inc. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, reported they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole) (Press release, Pfizer, NOV 30, 2017, View Source [SID1234522326]). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis1, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

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Under the terms of the agreement, Pfizer will have exclusive rights to develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific countries and China (including Hong Kong and Macao). These rights do not include Japan. In addition, Pfizer will become the marketing authorization holder for the Asia Pacific Region and China. The specific financial terms of the agreement remain confidential. The agreement is subject to customary regulatory approval.

In July 2017, Pfizer completed an agreement with Basilea to obtain the exclusive commercialization rights to CRESEMBA in Europe (with the exception of the Nordic countries). Since that time, Pfizer has assumed responsibility for the commercialization of CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom and successfully launched CRESEMBA in Spain with additional launches expected in 2018 and beyond.

CRESEMBA was developed in response to the urgent medical need for antifungal medicines for the treatment of invasive fungal infections, which are naturally resistant to many antifungal therapies and have become increasingly resistant to other available therapies. Today, invasive aspergillosis is the most frequently reported fungal infection in immunocompromised individuals within the Asian Pacific region.

"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, global president of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China, together with our expertise in successfully commercializing innovative medicines, will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."

"CRESEMBA is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections," said Ronald Scott, chief executive officer of Basilea. "We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.

About invasive aspergillosis and mucormycosis

Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection and those with cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. Today, there are limited treatment options available for patients diagnosed with invasive aspergillosis and mucormycosis.

About CRESEMBA (isavuconazole)

CRESEMBA is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.

On November 30, 2017 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that new data on the Company’s first FDA-approved anticoagulant, betrixaban, and its two investigational hematologic compounds – the anticoagulant reversal agent andexanet alfa and the oral, dual Syk/JAK kinase inhibitor cerdulatinib – will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 9-12 in Atlanta, Georgia (Press release, Portola Pharmaceuticals, NOV 30, 2017, View Source;p=RssLanding&cat=news&id=2319373 [SID1234522319]). The Company also will present outcomes-based research on prophylaxis of venous thromboembolism in two real-world settings.

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Oral Presentation Details:

• Presentation Title: Effect of Andexanet-TFPI Interaction on in Vitro Thrombin Formation and Coagulation Markers in the TF-Pathway

Session: 332 (Antithrombotic Therapy: Anticoagulation in Cancer and Beyond)
Presenter: Genmin Lu, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 at 11:30 a.m. ET
Location: Building B, Level 2, B207-B208 (Georgia World Congress Center)
Poster Presentation Details:

• Poster Title: Physiologically-Based Pharmacokinetic (PBPK) Modeling for Betrixaban and the Impact of P-glycoprotein Inhibition on Betrixaban Pharmacokinetics

Poster Session: 321 (Blood Coagulation and Fibrinolytic Factors: Poster III)
Presenter: Janet M. Leeds, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Impact of D-Dimer Assays Performed at Local Labs vs. Central Laboratory in the Evaluation of APEX Trial Outcomes

Poster Session: 332 (Antithrombotic Therapy: Poster II)
Presenter: Lisa Jennings, Ph.D., CirQuest Labs, Memphis, Tennessee
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Did Patients with Renal Disease Receive Sufficient Prophylaxis for Venous Thromboembolism in the Real-World Settings?: A Study Among Hospitalized Acutely Medically Ill Patients

Poster Session: 903 (Outcomes Research—Non-Malignant Conditions: Poster II)
Presenter: Donna Hesari, R.N., Portola Pharmaceuticals
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: The Frequency of Venous Thromboembolism (VTE) Prophylaxis Among Patients Hospitalized for Cancer in the US

Poster Session: 903 (Outcomes Research—Non-Malignant Conditions: Poster III)
Presenter: Andrea Hafeman, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Monday, Dec. 11, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)
• Poster Title: Cerdulatinib Pharmacodynamics and Relationships to Tumor Response Following Oral Dosing in Patients with Relapsed/Refractory B Cell Malignancies: Results from a Phase I Dose Escalation Study

Poster Session: 623 (Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II)
Presenter: Greg Coffey, Ph.D., Portola Pharmaceuticals
Presentation Date and Time: Sunday, Dec. 10, 2017 from 6:00 p.m. – 8:00 p.m. ET
Location: Building A, Level 1, Hall A2 (Georgia World Congress Center)

Important U.S. Safety Information for Bevyxxa (betrixaban) capsules

INDICATION
Bevyxxa is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

LIMITATIONS OF USE
The safety and effectiveness of Bevyxxa have not been established in patients with prosthetic heart valves because this population has not been studied.

SELECT IMPORTANT SAFETY INFORMATION

___________________________________________________________________________________________________________________________________________________

WARNING: SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS TREATED WITH BEVYXXA WHO ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THE RISK OF THESE EVENTS MAY BE INCREASED BY THE USE OF IN‑DWELLING EPIDURAL CATHETERS OR THE CONCOMITANT USE OF MEDICAL PRODUCTS AFFECTING HEMOSTASIS. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
___________________________________________________________________________________________________________________________________________________

CONTRAINDICATIONS

Active pathological bleeding
Severe hypersensitivity reaction to Bevyxxa

WARNINGS AND PRECAUTIONS
Risk of Bleeding

Bevyxxa increases the risk of bleeding and can cause serious and potentially fatal bleeding
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs)
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room
Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement
Discontinue Bevyxxa in patients with active pathological bleeding
There is no established way to reverse the anticoagulant effect of Bevyxxa, which can be expected to persist for at least 72hours after the last dose
It is unknown whether hemodialysis removes Bevyxxa
Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of Bevyxxa

Spinal/Epidural Anesthesia or Puncture

When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis
Do not remove an epidural catheter earlier than 72hours after the last administration of Bevyxxa. The next Bevyxxa dose is not to be administered earlier than 5hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Bevyxxa for 72hours
Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary
Prior to neuraxial intervention, consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis

Use in Patients with Severe Renal Impairment

Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault) taking Bevyxxa may have anincreased risk of bleeding events
Reduce dose of Bevyxxa, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients

Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors

Patients on concomitant P-gp inhibitors with Bevyxxa may have an increased risk of bleeding
Reduce dose of Bevyxxa in patients receiving or starting concomitant P-gp inhibitors, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients
Avoid use of Bevyxxa in patients with severe renal impairment receiving concomitant P‑gp inhibitors

ADVERSE REACTIONS

The most common adverse reactions with Bevyxxa were related to bleeding (> 5%)

USE IN SPECIFIC POPULATIONS
Hepatic Impairment

Bevyxxa has not been evaluated in patients with hepatic impairment, because these patients may have intrinsic coagulation abnormalities
Bevyxxa is not recommended in patients with hepatic impairment