On May 19, 2016 Clovis Oncology, Inc. (NASDAQ: CLVS) reported its presence at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where it will share updated results from clinical studies of rucaparib (Press release, Clovis Oncology, MAY 19, 2016, View Source;p=irol-newsArticle_Print&ID=2170005 [SID:1234512606]). ASCO (Free ASCO Whitepaper) will take place June 3-7, 2016 in Chicago.

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"We look forward to providing updates on rucaparib data in ovarian cancer, including in patients with mutations beyond BRCA, as well as the first presentation of our pancreatic cancer data," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "These datasets demonstrate rucaparib’s encouraging clinical activity and tolerability profile in the treatment of ovarian and pancreatic cancers. Both represent diseases in which BRCA mutations play a significant role in certain patients, as well as areas where additional treatment options are very much needed."

Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1-3 currently being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as "BRCA-like." Data from rucaparib studies are the subject of three poster presentations at the conference:

Abstract 4110 – RUCAPANC: An open-label, phase 2 trial of the PARP inhibitor rucaparib in patients (pts) with pancreatic cancer (PC) and a known deleterious germline or somatic BRCA mutation.

Susan M. Domchek, MD, University of Pennsylvania, Philadelphia, PA
Saturday, June 4 from 8:00am-11:30am CDT
Location: Hall A, Poster Board #102
Abstract 5540 – Refinement of prespecified cutoff for genomic loss of heterozygosity (LOH) in ARIEL2 part 1: A phase II study of rucaparib in patients (pts) with high grade ovarian carcinoma (HGOC).

Robert L. Coleman, MD, The University of Texas MD Anderson Cancer Center, Houston, TX
Monday, June 6 from 1:00pm-4:30pm CDT
Location: Hall A, Poster Board #363
Abstract 5549 – Feasibility of monitoring response to the PARP inhibitor rucaparib with targeted deep sequencing of circulating tumor DNA (ctDNA) in women with high grade serous carcinoma on the ARIEL2 trial.

Anna Piskorz, PhD, Cancer Research UK Cambridge Institute, University of Cambridge
Monday, June 6 from 1:00pm-4:30pm CDT
Location: Hall A, Poster Board #372
About Rucaparib

Rucaparib is an oral, potent small molecule inhibitor of PARP1-3 being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) commonly referred to as "BRCA-like." Clovis is also exploring rucaparib in other solid tumor types with significant BRCA and BRCA-like populations, including prostate, breast and gastroesophageal cancers. Rucaparib was granted Breakthrough Therapy designation by the U.S. FDA in April 2015. Clovis holds worldwide rights for rucaparib.

On May 19, 2012 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2016 (Press release, Nordic Nanovector, MAY 19, 2016, View Source [SID:1234512605]). A presentation of the results by the company’s senior management team will take place today at 8:30 a.m. CEST in Oslo – details below.

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Nordic Nanovector reports steady operational progress on Betalutin’s clinical development plan in Follicular Lymphoma (FL), with recruitment of both sites and patients proceeding according to schedule. The Lymrit 37-01 study is on track to define the optimized dose regimen to be used in PARADIGME, the pivotal Phase 2 study planned to start in 2H 2017. Updated data from this ongoing clinical study, presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in April, confirm Betalutin’s efficacy potential, durability of response and favourable safety profile in patients with advanced FL.

The company continues to advance its product pipeline. Having received clearance of the Investigational New Drug (IND) Application from the FDA and acceptance of the protocol design from EU Authorities, Nordic Nanovector is ready to initiate its Phase 1 clinical study for Betalutin in diffuse large B cell lymphoma (DLBCL). Other progresses include the research and development collaboration with Paul Scherrer Institute, aiming at developing new Antibody-Radionuclide-Conjugates (ARCs) for treatment of single cell leukaemias. During the first quarter, the company received a grant of up to NOK 15 million from the Research Council of Norway’s User-driven Research-based Innovation programme to support the discovery and development of novel targeted therapeutics for leukaemia and NHL.

Luigi Costa, CEO of Nordic Nanovector, comments: "We are pleased to report that our operations are progressing according to plan and on track to meet milestones. The updated results from Betalutin in FL are promising and reinforce our belief in its promise to become a significant new treatment of NHL. We have also made good progress across all key areas, including the initiation of a clinical study for Betalutin in a second NHL indication, with a significant unmet medical need, and promising preclinical research highlighting further opportunities for our pipeline."

Operational Highlights

• Steady operational progress on Betalutin’s clinical development plan in number of sites activated and patients enrolled

• Received grant from Research Council of Norway

• Presented updated clinical results at AACR (Free AACR Whitepaper) in April, which confirm Betalutin’s promising efficacy and increasing Duration of Response

• Received clearance of the Investigational New Drug (IND) application, enabling initiation of the study in the US, for a new Phase 1 clinical study of Betalutin in DLBCL

• Research and development collaboration entered with Paul Scherrer Institute, aiming at developing new Antibody-Radionuclide-Conjugates for treatment of single cell leukaemias

• First good manufacturing process batch of the chimeric HH1 antibody successfully completed

Financial Highlights Q1 2016

(Figures in brackets = same period 2015 unless otherwise stated)

• Revenues amounted to MNOK 0.078 (MNOK 0.076)

• Total operating expenses were MNOK 52.7 (MNOK 35.9)

• Loss for the quarter amounted to MNOK 52.7 (loss of MNOK 35.8)

• Cash and cash equivalents amounted to MNOK 671.9 at 31 March 2016 (MNOK 743.4 at 31 December 2015)

Outlook

The promising updated results from the ongoing Phase 1/2 study with Betalutin, the good progress made in advancing this study and strong findings from the research and development pipeline bode well for Nordic Nanovector’s operations going forward. Management will continue to focus its efforts on the efficient execution of its plans and to meet the anticipated clinical milestones. Current cash resources are expected to be sufficient to reach the first regulatory submission for Betalutin in FL in 1H 2019.

Presentation and web cast details

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST at:

Thon Hotel Vika Atrium Munkedamsveien 45 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investor Relations/Webcast.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Quarterly Reports/2016 from 7:00 am CEST the same day.

On May 19, 2016 Varian Medical Systems (NYSE: VAR) reported that it has been selected by the Apollo Hospitals Group to supply 12 advanced medical linear accelerators and five brachytherapy systems as India’s largest private hospital chain rolls out a program to replace ageing cancer treatment machines (Press release, Varian Medical Systems, MAY 19, 2016, View Source [SID:1234512604]). Based on an order placed in March, Varian will supply 11 TrueBeam systems, one Edge Radiosurgery system, and five GammaMed brachytherapy systems for the Apollo network over the next two years.

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The Edge Radiosurgery system, which will be installed in one of Apollo’s tertiary care centers, is a precise, non-invasive alternative to conventional surgery. With enhanced precision and speed, the Edge system offers state of the art radiosurgery and can treat a wide range of conditions across an ever increasing number of clinical indications. Varian’s flagship TrueBeam family of linear accelerators, to be installed at hospitals throughout the Apollo chain, incorporates numerous technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery during a radiotherapy or radiosurgery procedure.

As well as advanced treatment equipment, Apollo is ordering a full suite of Varian software tools including the Eclipse treatment planning system and ARIA oncology information management system, along with specific modules such as RapidPlan to enhance the speed and quality of treatment plans, and the InSightive Analytics real-time dashboard to maximize workflow in a clinic.

"We are pleased that Apollo has selected our technology-leading hardware and software to offer their cancer patients fast and precise treatments," says Ashok Kakkar, senior managing director of Varian India. "India is severely under-equipped when it comes to radiotherapy treatment machines and more than two million new cancer cases are detected each year in the country. Programs such as this help to make a big difference in the treatment of cancer patients in India."

Commenting on the collaboration, Dr. Preetha Reddy, executive vice chairperson of Apollo Hospitals Enterprise Limited said, "Healthcare has evolved by leaps and bounds in the past few years and technology has played a critical role in improving clinical outcomes for patients. Providing high quality healthcare on a par with global standards is our prime objective and we are glad to partner with Varian in this endeavor. Already enriched with highly skilled doctors, technicians and physicians, cutting edge technology will further enhance India’s positioning as a global healthcare destination."

Last year, Varian and Apollo announced a collaboration on the first radiotherapy educational co-operation of its kind between industry and a care provider in India. In this collaboration, Varian and Apollo will work together to bring greater access to training in modern radiotherapy by leveraging the existing Apollo Knowledge network that comprises several educational entities in the healthcare space in India. This collaboration with Apollo is a furtherance of Varian’s Access to Care program, which seeks to bridge the gap between the growing need for modern radiotherapy treatment machines in developing countries and the lack of trained personnel to operate them.

On May 19, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported the availability online of an abstract titled "Intralesional rose bengal for treatment of melanoma" to be presented as a poster at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") being held in Chicago June 3-7, 2016 (Press release, Provectus Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512598]).

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To see this abstract, visit: View Source

The poster for the abstract, ID: TPS9600, is scheduled for presentation June 4, 2016, running from 1:00-4:30 Central Daylight Time.

On May 19, 2016 OncoCyte Corporation (NYSE MKT: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported the abstract of data from a bladder cancer study that will be presented as a poster and also highlighted during a live panel discussion on June 6, 2016, during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in Chicago, Illinois (Press release, BioTime, MAY 19, 2016, View Source [SID:1234512597]).

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"Our bladder test results are highly encouraging and reflect the depth of quality diagnostics products in our robust pipeline," commented OncoCyte Chief Executive Officer William Annett. "There is a high unmet need for non-invasive tests for bladder cancer and our gene expression classifiers have been shown to provide superior sensitivity in a procedure that is less invasive to patients than the current standard of care. Our results indicate the feasibility of using a urine-based diagnostic test to detect urothelial carcinoma both in screening (hematuria) and recurrence settings."

The abstract entitled Derivation of Gene Expression Classifiers for the Non-invasive Detection of Bladder Cancer in the Hematuria and Recurrence Surveillance Populations, describes OncoCyte’s recent results in the development of a urine-based test for bladder cancer. The detection of bladder cancer is typically accomplished with a combination of cystoscopy and urine cytology, each with inherent limitations. Urine cytology lacks the desired level of sensitivity, whereas cystoscopy is relatively invasive for routine screening and recurrence surveillance. OncoCyte’s study describes the development of four gene expression classifiers (GECs) optimized for the non-invasive detection of both high-grade and low-grade urothelial carcinoma in patients presenting with hematuria or for bladder cancer recurrence surveillance. The results for high-grade screening, high-grade recurrence, low-grade screening and low-grade recurrence were all obtained from single urine samples utilizing four different algorithms. A multi-center study involving 241 patient urine samples was used in the development of this assay.

OncoCyte’s approach of sequential GECs optimized for the detection of high-grade and low-grade malignancies provides the necessary data to distinguish between these different types of lesions and benign conditions in a non-invasive manner. Low-grade urothelial carcinoma is usually a non-aggressive cancer, whereas high-grade urothelial carcinoma is more aggressive, invasive and causes significantly more cancer-related mortality than low-grade urothelial carcinoma.

The GEC optimized for the detection of high-grade urothelial carcinoma in patients presenting with hematuria performed, with a cross-validated ROC AUC of 0.93, while the low-grade performed with an AUC of 0.81. In the recurrence surveillance cohort, the detection of high-grade performed with an AUC of 0.81 and low-grade with an AUC of 0.64. The following table summarizes these results.

ROC AUCs

Low Grade High Grade
Screening (Hematuria) 0.81 0.93

Recurrence 0.64 0.81
"These data establishes the feasibility of our approach, and we look forward to continuing our larger, multicenter study to further validate these findings," added Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research, who led the study.

About Bladder Cancer

Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease. The detection of bladder cancer in Hematuria and Recurrence patients is routinely accomplished with a combination of urine cytology and cystoscopy which is invasive, and lacks the desired level of sensitivity.