On March 27, 2017 Cellceutix Corporation, (OTCQB: CTIX) ("the Company"), reported positive results from the Company’s ongoing randomized, double-blind Phase 2 study of Brilacidin in the prevention and control of Oral Mucositis (OM) in patients receiving chemoradiation for treatment of Head and Neck Cancer (Filing, 8-K, CellCeutix, MAR 27, 2017, View Source [SID1234518285]). In a preliminary interim analysis, a marked reduction in incidence of Severe OM (WHO Grade > 3) was observed in patients treated with Brilacidin who received at least 55 Gy cumulative units of radiation. Study results, complementing favorable data released last week in the treatment of Ulcerative Proctitis/Proctosigmoiditis with Brilacidin, further establish Brilacidin as a novel anti-inflammatory drug candidate with potentially broad applications. Schedule your 30 min Free 1stOncology Demo!
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Presented below is information on Cellceutix’s clinical trial of Brilacidin for OM, including preliminary Interim Analysis of 19 patients (9 administered Brilacidin; 10 administered placebo) who have reached or passed the planned visit at the end of 5 weeks on study, and received a cumulative radiation dose of at least 55 Gy.
STUDY DESIGN
CTIX-BRI-205 is a Phase 2 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Brilacidin as an oral rinse in preventing and controlling OM in patients receiving chemoradiation therapy for Head and Neck Cancer. The study is anticipated to enroll approximately 60 patients in the United States, 30 each to Brilacidin treatment or to placebo (water). Brilacidin (45 mg/15 ml oral rinse—"swish and spit") is administered 3 times daily across 7 weeks (49 days). Pharmacokinetics of Brilacidin are to be evaluated if there is measurable systemic exposure (from drug concentrations in plasma).
The Brilacidin OM trial uses a World Health Organization (WHO) OM Grading Scale, a common measurement tool in assessing the presence and severity of OM, as defined below.
WHO Scale for OM
· Grade 0 = None
· Grade 1 = Erythema and Mouth Pain Soreness; no Ulceration/Pseudomembrane formation
· Grade 2 = Ulceration/Pseudomembrane formation; solid diet
· Grade 3 = Ulceration/Pseudomembrane formation; liquid diet
· Grade 4 = Ulceration/Pseudomembrane formation; not able to tolerate a solid or liquid diet (except enough liquid for medication)
Primary Endpoints of the Brilacidin OM trial are:
· Incidence of Severe OM (WHO Grade > 3) experienced during radiation therapy (across 7 weeks) by patients with Head and Neck Cancer receiving a cumulative radiation dose of at least 55 Gy in the course of their chemoradiation treatment
·
Safety and Tolerability of Brilacidin
A Secondary Endpoint included in the Interim Analysis is:
· Duration of Severe OM (WHO Grade > 3)
Pharmacokinetics of Brilacidin is determined from:
· Brilacidin concentrations in plasma
INTERIM ANALYSIS
Preliminary efficacy and safety data from 19 patients who met the criteria for evaluation were reviewed. To be included, patients needed to have reached or passed the planned visit at the end of 5 weeks on study, and have received a cumulative radiation dose of at least 55 Gy. Patients receiving Brilacidin, as compared to patients on placebo, showed a markedly reduced rate of Severe OM (WHO Grade > 3). Additionally, Brilacidin was generally safe and well-tolerated.
Primary Efficacy Results Incidence of Severe OM (WHO Grade > 3)
· Active Arm (Brilacidin): 2 of 9 patients (22.2 percent)
· Control Arm (Placebo): 7 of 10 patients (70 percent)
Secondary Efficacy Results Duration of Severe OM (WHO Grade > 3)
· Active Arm (Brilacidin): Mean 10.5 days (Range 3 to 18 days; 2 patients)
· Control Arm (Placebo): Mean 14 days (Range 3 to 39 days; 7 patients)
2
Safety and Tolerability Profile
· Brilacidin administered as an oral rinse was generally well-tolerated by patients
· Safety findings were typical for patients with Head and Neck Cancer being treated with chemoradiation; no treatment group differences were apparent on vital signs and clinical laboratory safety tests
·
Six patients (2 in Active Arm, 4 in Control Arm) experienced at least one adverse event categorized as serious. Nine Serious Adverse Events (SAEs) were reported for these 6 patients, and all were classified by the Investigator as Not Related to study drug
· Incidence of Treatment-Emergent Adverse Events (TEAEs)
o
Majority of the TEAEs reported (Active Arm, 164 TEAEs; Control Arm, 143 TEAEs) were related to chemoradiation or the underlying study indication
o
No TEAEs were classified as Likely Related or Definitely Related to study treatment
Pharmacokinetics
· Plasma samples from 6 patients treated with Brilacidin were analyzed and all concentrations of Brilacidin were below the lower limit of quantification (i.e., < 10 ng/mL)
"These interim results suggest the potential for an even greater effective therapeutic response as formulation and dosing is further optimized," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. "There currently is no existing preventative treatment available for OM patients in this population, with only limited therapies focusing on symptom relief. Already under Fast Track designation, should Brilacidin earn FDA approval for the treatment of Oral Mucositis, countless patients may no longer have to suffer from this horribly debilitating condition as a side effect of cancer treatment. The use of Brilacidin to prevent the onset of OM could even lead to an entirely new standard of care in this area as we strive to bring this drug to market."
Cellceutix, over the past months, has added additional clinical sites to this study. Completion of the clinical trial is expected before year-end.
Alerts:
Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alerts
About Brilacidin
Brilacidin is Cellceutix’s lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the "front-line" of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, Cellceutix is studying Brilacidin’s effect on oral mucositis (under Fast Track designation) and on ulcerative proctitis/proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: hidradenitis suppurativa and acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and a potential extra 5 years of United States market exclusivity upon drug approval.
Learn more here:
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Month: March 2017
TESARO Announces Expanded Development Program for Niraparib Focused on the Treatment of Front-Line Metastatic Ovarian and Lung Cancers and Metastatic Breast Cancer
On March 27, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported a substantial expansion of its niraparib clinical development program (Press release, TESARO, MAR 27, 2017, View Source [SID1234518284]). Following the landmark results of the Phase 3 NOVA trial of niraparib, a comprehensive portfolio review, and the FDA approval of ZEJULA (niraparib) for patients with recurrent ovarian cancer, TESARO is implementing its plans to initiate registration strategies in the settings of metastatic ovarian, breast and lung cancers.
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"Based on the unprecedented results of the NOVA trial in women with recurrent ovarian cancer, we previously announced the expansion and refinement of our PRIMA and QUADRA trials to include a broad patient population, and in the case of PRIMA, eliminated the enrollment requirement for a biomarker selected tumor. With the approval of ZEJULA in hand, we will now begin to execute on our plans to pursue potentially transformational applications of niraparib in a broad range of metastatic cancer indications," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We plan to expand our first-line ovarian cancer strategy to include a combination study that assesses the potential benefit of niraparib plus an anti-PD-1 antibody in the maintenance setting and initiate a clinical study of niraparib in combination with bevacizumab in patients with a first recurrence of ovarian cancer, with an intent to replace chemotherapy in this setting. We remain strongly committed to studying niraparib in the breast cancer setting and also expect to initiate a new trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Finally, our goal to move niraparib into indications beyond ovarian and breast cancers encompasses plans to initiate a registration strategy for the first-line treatment of patients with metastatic non-small cell lung cancer that includes a phase 2 trial of niraparib in combination with an anti-PD-1 antibody in patients, regardless of PDL-1 tumor expression, and a phase 3 trial of niraparib in combination with an anti-PD-1 antibody in patients with high levels of PDL-1 tumor expression."
Niraparib is the only PARP inhibitor approved in the U.S. for the maintenance treatment of women with recurrent ovarian, fallopian or primary peritoneal cancers. This approval was based upon the results of a randomized, prospectively designed Phase 3 clinical trial where niraparib demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer following a response to platinum-based chemotherapy.
The BRAVO study is assessing niraparib in patients with breast cancer who are germline BRCA mutation carriers. This study is sponsored by TESARO and is being conducted by Breast International Group (BIG) and the European Organisation for Research and Treatment of Cancer (EORTC). Following a recent interim analysis of data by the independent data monitoring committee (IDMC), TESARO believes the BRAVO study is unlikely to produce data that is interpretable and therefore suitable for registration in this indication. A large number of patients in the chemotherapy control arm did not continue in the trial long enough to receive their first radiological scan, which is required to assess disease progression, resulting in an unusually high rate of censoring in the control arm. At this time, TESARO believes this is likely associated with the desire of patients who carry germline BRCA mutations to be treated with a PARP inhibitor rather than chemotherapy and the increased availability of PARP inhibitors. A final determination as to whether the planned enrollment in BRAVO should be completed will be made by the Steering Committee in the near term. No safety concerns have been noted by the IDMC with respect to niraparib. Approximately 5-10% of women with breast cancer are germline BRCA mutation carriers. TESARO expects the results and experience gained from the BRAVO trial to be supportive of the planned trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Approximately 15-20% of women with breast cancer have triple negative breast cancer.
The expanded niraparib clinical development program now includes the following:
Ovarian Cancer
OvCa 3000-03-003: A Phase 3 clinical trial of niraparib in combination with an anti-PD-1 antibody in comparison to niraparib in first-line maintenance treatment of patients with advanced ovarian cancer who have responded to platinum induction therapy.
OvCa 3000-03-002: A Phase 3 clinical trial of niraparib in combination with bevacizumab in comparison to standard of care in patients with a first recurrence of ovarian cancer.
PRIMA: A Phase 3 clinical trial of niraparib in patients with advanced ovarian cancer who have responded to platinum induction therapy.
TOPACIO: A Phase 2 trial to evaluate the preliminary safety and efficacy of niraparib plus KEYTRUDA in patients with triple negative breast cancer and in patients with platinum resistant recurrent ovarian cancer being conducted by TESARO in collaboration with Merck.
QUADRA: A registration trial of niraparib for the treatment of patients with recurrent ovarian cancer who have received three or four regimens of therapy.
AVANOVA: An NSGO (Nordic Society of Gynaecological Oncology) Phase 1/2 trial (in collaboration with ENGOT) evaluating niraparib plus bevacizumab in patients with recurrent ovarian cancer.
Breast Cancer
TNBC 3000-03-004: A Phase 3 clinical trial of niraparib in combination with anti- PD-1 antibody in comparison to standard of care in patients with advanced triple negative breast cancer.
TOPACIO: A Phase 2 clinical trial to evaluate the safety and efficacy of niraparib plus KEYTRUDA in patients with triple negative breast cancer and patients with platinum resistant recurrent ovarian cancer being conducted by TESARO in collaboration with Merck.
Lung Cancer
Lung 3000-02-001: A Phase 2 clinical trial of niraparib in combination with an anti-PD-1 antibody in patients with advanced NSCLC and niraparib alone in patients with advanced squamous cell carcinoma of the lung.
Lung 3000-03-001: A Phase 3 clinical trial of niraparib in combination with an anti-PD-1 antibody in comparison to anti-PD-1 alone in patients with advanced NSCLC and high levels of PDL-1 tumor expression.
Prostate Cancer
Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.
TESARO Investor Conference Call and Webcast
TESARO will webcast a conference call with investors and analysts today, March 27, 2017 at 4:30 PM ET. Investors and analysts may access this call by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international); no passcode is necessary. During this conference call, TESARO management will review the approval of ZEJULA and expanded niraparib development program, as well as answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.
About ZEJULA (Niraparib)
ZEJULA (niraparib) is an oral, once-daily poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.
Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in all clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.
Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.
In clinical studies, the most common adverse reactions included: thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, abdominal pain/distension, mucositis/stomatitis, diarrhea, fatigue/asthenia, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash and hypertension.
Please see full Prescribing Information for additional Safety Information.
NanoString Highlights a Record Number of nCounter-Based Research Abstracts in Precision Oncology and Predictive Biomarkers at the 2017 American Association of Cancer Research (AACR) Annual Meeting
On March 27, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the upcoming presentation of recent research in precision oncology and predictive biomarkers using the nCounter Analysis System (Press release, NanoString Technologies, MAR 27, 2017, View Source [SID1234518283]). More than 45 NanoString-related abstracts will be presented at the Annual Meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper), which is being held April 1-5, 2017, in Washington, DC. Schedule your 30 min Free 1stOncology Demo! "We are proud to see our products and technologies being used so broadly to advance the understanding of cancer. We salute these researchers and the groundbreaking contributions to cancer research that are being presented at the 2017 Annual Meeting of the AACR (Free AACR Whitepaper)," said Brad Gray, president and chief executive officer of NanoString Technologies. "Our nCounter technology has become an essential tool for biomarker research, and we continue to expand the capabilities and content to drive adoption in other areas of research such as autoimmune syndromes, infectious disease and neurology."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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The 2017 AACR (Free AACR Whitepaper) abstracts describe research applications that underscore the diverse capabilities and robust performance of the nCounter platform. These studies cover a wide range of cancers, tissue types (FFPE, peripheral blood and urine), and treatment modalities. There are at least 33 abstracts authored by academic researchers and 13 by biopharma researchers. These abstracts span translational research from biomarker validation and disease characterization, to drug resistance and autoimmune toxicities of checkpoint inhibitors.
NanoString will be exhibiting at AACR (Free AACR Whitepaper) (booth# 3115) and hosting a workshop entitled "Powering Precision Oncology Research with 3D Biology Technology: High Plex Multi-Analyte Profiling on FFPE with Spatial Resolution" at 10:00am ET on Monday April 3.
Abstract # Title Hyperlink
471/12 HER2 regulates PARP-1 expression by suppressing the let-7a microRNA in HER2+ breast cancer View Source!/4292/presentation/2057
414/14 Identifying selective vulnerabilities in colorectal cancer molecular subtypes using in vivo functional genomic screens View Source!/4292/presentation/6665
811/17 Histological heterogeneity contributes to sunitinib resistance in clear cell renal cell carcinoma View Source!/4292/presentation/1784
588/22 Advanced molecular characterization of severe autoimmune toxicities associated with checkpoint inhibitor therapies View Source!/4292/presentation/6096
491/5 Elucidating de novo PATRR-mediated t(3;8) balanced translocation and clear cell renal cell carcinoma View Source!/4292/presentation/1159
829/7 MicroRNA regulation of radiation sensitivity in colorectal cancer View Source!/4292/presentation/2397
1682/1 Correlation of immune co-stimulatory molecule OX40 and outcome in trastuzumab treated HER2-positive breast cancer patients in the NCCTG-N9831. View Source!/4292/presentation/5987
1750/10 Analysis of non-metastatic HCC patient tumors revealed the significance of cell cycle regulation and tumor immunity in association with overall survival and identified clinically relevant druggable targets View Source!/4292/presentation/2931
1469/11 Integrated analysis of microRNA, mRNA, and protein expression utilizing MultiOmyx and NanoString from formalin-fixed paraffin-embedded, lung, head and neck, breast, and melanoma tumors View Source!/4292/presentation/2080
1785/15 Technical validation of novel 325 RNA predictive biomarkers using gene expression data generated by Nanostring n-counter and Affymetrix microarray View Source!/4292/presentation/1589
1904/5 Novel 5-fluorouracil-thymoquinone hybrid kills colon cancer stem cells View Source!/4292/presentation/5919
2088/15 The activity of the FGFR selective inhibitor Debio 1347 is correlated with high mRNA expression View Source!/4292/presentation/3926
2841/14 Investigating drivers of disease progression in invasive lobular carcinoma View Source!/4292/presentation/3513
2441/28 NanoString 3D Biology technology: simultaneous digital counting of DNA, RNA and protein View Source!/4292/presentation/6870
2251/5 Tumor tissue gene expression in association with survival of triple-negative breast cancer View Source!/4292/presentation/2562
2422/9 Simultaneous detection of activating somatic DNA mutations and expressed fusion transcripts from lung tumor FFPE samples View Source!/4292/presentation/6827
3814/10 A pan cancer analysis of the tumor inflammation signature View Source!/4292/presentation/1652
3612/11 Combination FGFR4 and ER-targeted therapy for invasive lobular carcinoma View Source!/4292/presentation/2276
3431/11 The oncogenic role of miR-150-5p in triple-negative breast cancer View Source!/4292/presentation/2127
3706/19 Validation of human and mouse myeloid panels on the NanoString nCounter Platform View Source!/4292/presentation/3240
3738/23 Use of tumor mRNA expression for patient selection in a phase I study of the pan-fibroblast growth factor receptor inhibitor BAY 1163877 View Source!/4292/presentation/3003
3955/22 Spatially resolved, multiplexed digital characterization of protein and mRNA distribution and abundance in formalin-fixed, paraffin-embedded (FFPE) tissue sections based on NanoString’s Digital Spatial Profiling (DSP) technology: applications to immuno-oncology (IO) and tumor heterogeneity View Source!/4292/presentation/3416
3652/25 Combinational activity of LAG3 and PD-1 targeted therapies is significantly enhanced by the addition of phosphatidylserine targeting antibodies and establishes an anti-tumor memory response in murine triple negative breast cancer View Source!/4292/presentation/6260
3983/26 A cross comparison of technologies for the detection of immune system related gene expression signatures in clinical FFPE samples of metastatic prostate cancer patients View Source!/4292/presentation/9068
3684/27 Inhibition of STAT3 by antisense oligonucleotide treatment decreases the immune suppressive tumor microenvironment in syngeneic and GEM tumor models View Source!/4292/presentation/6345
3423/3 Elucidation of the role of miR-575 on tumorigenesis in glioblastoma View Source!/4292/presentation/2119
3810/6 Validation of novel high-plex protein spatial profiling quantitation based on NanoString’s Digital Spatial Profiling (DSP) technology with quantitative fluorescence (QIF) View Source!/4292/presentation/1648
3377/8 Simultaneous analysis of the mutational landscape and RNA and protein expression profile of HER2-positive breast cancer using 3D Biology View Source!/4292/presentation/6631
NG04 Mechanisms of resistance to anti-PD-1 immunotherapy through interferon pathway mutations View Source!/4292/presentation/11061
4649/10 Development of an ethnicity informed gene expression panel with potential to improve prostate cancer diagnosis View Source!/4292/presentation/1628
4334/13 Interleukin-6 is a key player in stroma-induced resistance to chemotherapy for gastric carcinomas View Source!/4292/presentation/5224
4387/19 The clonal composition of colorectal cancer cell lines is defined by the maintenance of specific genomic imbalances, not by ongoing chromosomal instability View Source!/4292/presentation/6569
4197/20 Interaction of B lymphoma cells with the microenvironment affects ibrutinib sensitivity View Source!/4292/presentation/3904
4442/20 micoRNA in FA defective tumor View Source!/4292/presentation/2156
4262/28 Inflammatory gene expression differences among prostate cancer patients exposed to the World Trade Center aftermath View Source!/4292/presentation/4794
4971 IACS-010759, a novel inhibitor of complex I in Phase I clinical development to target OXPHOS dependent tumors View Source!/4292/presentation/3226
5000 A stromal liver gene signature predictive of HCC risk across all liver disease etiologies View Source!/4292/presentation/7455
5095/11 Development of a pharmacodynamic biomarker assay for AZD4785, an antisense oligonucleotide targeting KRAS View Source!/4292/presentation/2614
5448/13 An exosomal biomarker for prostate cancer View Source!/4292/presentation/2172
5645/17 Associations between biomarkers and outcome in a patient cohort with invasive lobular carcinoma View Source!/4292/presentation/993
5563/21 3D Biology view of cancer: Simultaneous detection of somatic DNA mutations and expression profiling of genes and signaling proteins from melanoma tumor FFPE samples View Source!/4292/presentation/1756
5726/20 A novel tumor-promoting role for miR-4516 in glioblastoma View Source!/4292/presentation/1479
5757/21 Study of human mammary tumor virus (HMTV) in human breast cancer by NanoString nCounter and FISH analysis View Source!/4292/presentation/2332
5652/6 Translational evidence of reactivated innate and adaptive immunity with intratumoral IMO-2125 in combination with systemic checkpoint inhibitors from a Phase I/II study in patients with anti-PD-1 refractory metastatic melanoma View Source!/4292/presentation/6014
5350/6 A comprehensive and integrated approach to genomic and proteomic analysis of FFPE NSCLC tumor specimens View Source!/4292/presentation/6724
5092/8 ZVex lentiviral vector strongly activates pro-inflammatory, antigen processing, and antiviral defense response pathways in monocyte-derived dendritic cells
Roche announces launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets accepting the CE mark
On March 27, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the CE-IVD launch of cobas HPV for use on the cobas 6800/8800 Systems for cervical cancer screening (Press release, Hoffmann-La Roche, MAR 27, 2017, View Source [SID1234518282]). Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, and gives laboratories the ability to run HPV DNA testing simultaneously with other previously released cobas assays including: Chlamydia and Gonorrhea (CT/NG), HIV-1, HCV, HBV, CMV, plus three next-generation assays for donor screening: cobas MPX, cobas WNV and cobas HEV. Schedule your 30 min Free 1stOncology Demo! As demonstrated by the prospective clinical study "ATHENA" comparing screening strategies using cobas HPV test on the cobas 4800 System, screening with the HPV test detects more high-grade disease than a Pap test alone. Identifying women at risk, before pre-cancer or cancer develops, is an important prevention strategy as it helps maintain screening efficiency and helps protect women from the potential harms of overtreatment. Countries are increasingly looking to adopt HPV DNA screening ahead of Pap cytology as part of their national cervical cancer programs.
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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"In addition to the powerful clinical benefits of the cobas HPV test, Roche now caters to the needs of both low-to-mid volume labs and high-throughput labs who want to consolidate a multitude of validated assays onto a single platform," said Roland Diggelmann, CEO Roche Diagnostics. "As laboratories look toward the future, they require systems that provide the highest performance standards that Roche delivers as well as new ways to increase efficiency, which ultimately benefit everyone receiving or providing health care."
The fully automated cobas 6800/8800 Systems provide the fastest turn-around time, highest throughput and the longest walk-away time compared to other automated molecular platforms, giving laboratories the flexibility to adapt to changing testing demands.
About the Roche Cervical Cancer Portfolio
The Roche Cervical Cancer Portfolio enables healthcare professionals to better screen, manage and diagnose women, based on the confidence and clarity of results across a continuum of patient care. The unique combination of molecular, cellular and tissue-based diagnostic tests provides healthcare professionals powerful information to make patient care decisions and minimize unnecessary treatment.
cobas HPV testing is clinically validated for HPV primary screening, ASC-US triage, or co-testing (HPV and Pap cytology) using the cobas 4800 or cobas 6800/8800 Systems *. The cobas HPV assays provides specific genotyping information for HPV 16 and HPV 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one test and from one patient sample. More information about cobas HPV is available at www.hpv16and18.com.
Using advanced, dual-biomarker technology to simultaneously detect p16 & Ki-67, CINtec PLUS Cytology* definitively identifies transforming HPV infections, providing greater certainty to clinicians to stratify patients for follow-up or intervention. CINtec PLUS Cytology* is an objective triage solution for managing HPV-positive or abnormal Pap cytology primary screening results and helps address some of the limitations of traditional Pap cytology.
CINtec Histology is used to confirm the presence or absence of high-grade cervical disease in women who have had a tissue biopsy. CINtec Histology uses the p16 biomarker for a more conclusive diagnosis to provide distinctive visual confirmation of pre-cancerous cervical lesions that may be missed by H&E or morphologic interpretation alone. Both CINtec assays have been fully automated on the VENTANA BenchMark IHC/ISH instruments*.
About Human Papillomavirus and Cervical Cancer
Persistent infection with high-risk Human Papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. It can take 10 to 15 years or longer for cervical cancer to develop, so knowing a woman’s individual risk and finding disease early, before cancer develops, is an important prevention strategy. The World Health Organization estimates there are more than 500,000 new cases of cervical cancer annually.
About the cobas 6800/8800 Systems
The cobas 6800 and cobas 8800 systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health and microbiology. Based on Nobel prize-winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.
The systems provide up to 96 results in less than 3.5 hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800) and four hours (cobas 8800) of walk-away time with minimal user interaction.
Additional molecular assays for use on the cobas 6800/8800 Systems include: cobas HIV-1, cobas HCV; cobas HBV and cobas CMV plus three next-generation assays for donor screening: cobas MPX, cobas WNV and cobas HEV.
For more information about the Systems, visit www.cobas68008800.com or View Source
Endocyte Announces Presentations at American Association for Cancer Research (AACR) Annual Meeting 2017
On March 27, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that eight posters will be presented by Endocyte scientists at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 to be held in Washington, DC, April 1 – 5, 2017 (Press release, Endocyte, MAR 27, 2017, View Source [SID1234518281]). Schedule your 30 min Free 1stOncology Demo! Key presentations during the meeting include a late-breaking poster presentation of new research from investigators and faculty at the Purdue University Center for Drug Discovery on the application of Endocyte’s SMDC technology in a chimeric antigen receptor (CAR) therapy setting. Additionally, the company will present several posters with preclinical data relating to Endocyte’s SMDC technology, including developments in combination therapies and novel proPBD warheads.
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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The presentation materials will be available on Endocyte’s website following presentation at the conference.
Presentations are as follows:
Abstract #: 2057
Title: Evaluation of anti-tumor efficacy of EC1456 in low-passage and pre-treated patient-derived xenograft models of triple-negative breast cancer
When: Monday, April 3, 1 p.m. – 5 p.m. CDT
Session Title: Drug Resistance: Other Topics
Location: Halls A-C, Poster Section 3
Abstract #: 2133
Title: Pre-clinical studies of EC2629, a highly potent FR targeted DNA crosslinking agent
When: Monday, April 3, 1 p.m. – 5 p.m. CDT
Session Title: New Targets 2
Location: Halls A-C, Poster Section 6
Abstract #: LB-187
Title: New methods for controlling CAR T-cell mediated cytokine storms
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Late-Breaking Research: Immunology
Location: Poster Section 35
Abstract #: 3670
Title: Treatment of epithelial ovarian cancer with folate receptor (α/β) targeted chemotherapy is enhanced by CTLA-4 blockage: Learning from animal models
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Dendritic Cells as Critical Immune Targets
Location: Halls A-C, Poster Section 27
Abstract #: 3228
Title: Development and characterization of in vitro assays to detect and quantitate tubulysin B hydrazide in biological samples
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Novel Molecular Targets 2
Location: Halls A-C, Poster Section 8
Abstract #: 4017
Title: Development and application of an immunohistochemistry-based assay for evaluating functional and accessible folate receptor expression in vivo
When: Tuesday, April 4, 1 p.m. – 5 p.m. CDT
Session Title: Assay Technology
Location: Halls A-C, Poster Section 1
Abstract #: 4574
Title: Combinatorial strategies of folate receptor-targeted chemotherapy guided by improved understanding of tumor microenvironment and immunomodulation
When: Tuesday, April 4, 1 p.m. – 5 p.m. CDT
Session Title: Clinical Immunotherapy, Viruses, and bacteria
Location: Halls A-C, Poster Section 25
Abstract #: 5147
Title: Novel warheads for targeted therapies of cancer: The concept and design of proPBDs
When: Wednesday, April 5, 8 a.m. – 12 p.m. CDT
Session Title: Novel Drug Delivery Technology
Location: Halls A-C, Poster Section 5
About Endocyte’s SMDC Bi-Specific Adaptors
Endocyte’s SMDC bi-specific adaptors represent a novel approach that makes possible the engineering of a single universal CAR T-cell, designed to bind with high affinity to fluorescein isothiocyanate (FITC). This universal CAR T-cell can be specifically directed to cancer cells through the administration of a tumor targeted FITC-containing SMDC, known as a bi-specific adaptor that acts to bridge the universal CAR T-cell with the cancer cells to cause localized T-cell activation. This approach has been shown pre-clinically to address three key CAR T-cell issues by: (i) avoiding hyper-activation of CAR T-cells leading to a cytokine storm, (ii) enabling termination of CAR T-cell activity upon eradication of the tumor, and (iii) potentially enabling elimination of all cancer cells in heterogeneous solid tumors. In March 2017, Endocyte entered into a research collaboration with Seattle Children’s Research Institute and Dr. Michael Jensen for the development of Endocyte’s SMDC platform in the chimeric antigen receptor T-cell (CAR T-cell) immunotherapy setting through the use of Endocyte’s proprietary SMDC bi-specific adaptor molecules.