On May 16, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the Bernstein 34th Annual Strategic Decisions Conference in New York, NY (Press release, Allergan, MAY 16, 2018, View Source(1) [SID1234526735]). The presentation will begin at 10:00 a.m. Eastern Time on Wednesday, May 30, 2018.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: https://cc.talkpoint.com/bern0…

An archived version will be available within approximately 3 hours of the live presentation, and can be accessed at the same location for 180 days

On May 16, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported it will present data from preclinical studies of inhaled NanoPac (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC) (Press release, NanOlogy, MAY 16, 2018, View Source [SID1234526907]).

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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 data will be presented in an abstract entitled "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model" during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 3rd, from 8:00 AM to 11:30 AM in Hall A of McCormick Place in Chicago.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in rat lung tissue following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression.

Gere diZerega, MD, VP of Medical Affairs, said, "In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials."

Lung cancer is by far the leading cause of cancer death according to the American Cancer Society with more than 154,000 deaths expected this year. More people die of lung cancer every year than breast, prostate, and colon cancers combined.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

On May 16, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported that data from its Phase 2b clinical trial of GC4419 for severe oral mucositis in patients with head and neck cancer will be presented during an oral abstract session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 1-5, 2018 in Chicago (Press release, Galera Therapeutics, MAY 16, 2018, View Source [SID1234526703]). GC4419 is a highly selective and potent small molecule dismutase mimetic that rapidly converts superoxide to hydrogen peroxide and oxygen.

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Presentation details are as follows:

Title: Results of a randomized, placebo (PBO) controlled, double-blind P2b trial of GC4419 (avasopasem manganese) to reduce duration, incidence and severity and delay onset of severe radiation-related oral mucositis (SOM) in patients (pts) with locally advanced squamous cell cancer of the oral cavity (OC) or oropharynx (OP)

Abstract Number: 6006

Oral Abstract Session: Head and Neck Cancer

Date / Time / Location: June 3, 2018 / 10-10:12 a.m. CDT / McCormick Place E451

Presenter: Carryn M. Anderson, MD, Radiation Oncologist, University of Iowa Hospitals and Clinics

The abstract has also been selected for inclusion in the 2018 Best of ASCO (Free ASCO Whitepaper) program, which aims to increase global access to cutting-edge science by condensing highlights from ASCO (Free ASCO Whitepaper)’s Annual Meeting into a two-day program to be held this summer.

For information about the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit View Source

About GC4419

GC4419 is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. GC4419 works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

GC4419 has been studied in patients with head and neck cancer, GC4419’s lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis (SOM). Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.

On May 16, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five ZEJULA (niraparib) abstracts, including two oral presentations, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1 to June 5, 2018, in Chicago, Illinois (Press release, TESARO, MAY 16, 2018, View Source [SID1234526719]). In addition, TESARO will webcast an investor and analyst briefing on Monday, June 4 at 6:15PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting.

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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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"TESARO has a targeted clinical development program to assess ZEJULA monotherapy activity in the front-line ovarian cancer setting and in combination with bevacizumab or anti-PD-1 in ovarian, breast and lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, we look forward to oral presentations of results from the TOPACIO trial of niraparib plus anti-PD-1 in patients with triple-negative breast cancer or recurrent ovarian cancer, and a poster presentation of data from the QUADRA trial, which evaluated niraparib as a treatment for patients with advanced ovarian cancer."

Please plan to visit TESARO at Booth #10123 to learn more about ZEJULA, TSR-042 (anti-PD-1 antibody), TSR-022 (anti-TIM-3 antibody), and TSR-033 (anti-LAG-3 antibody).

Presentation Details:

Sunday, June 3, 2018, 9:45AM to 11:15AM
TOPACIO/Keynote-162 (NCT02657889): A phase 1/2 study of niraparib + pembrolizumab in patients (pts) with advanced triple-negative breast cancer or recurrent ovarian cancer (ROC): results from ROC cohort.
Oral Presentation; Abstract #106, 10:21AM, Location: Hall D1

Monday, June 4, 2018, 1:15PM to 4:45PM
Cost-effectiveness of niraparib versus routine surveillance, olaparib, and rucaparib for the maintenance treatment of adult patients with ovarian cancer in the United States.
Poster Presentation; Abstract #5559, Poster Board #286, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
OVARIO: The phase 2, single-arm, open-label study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer following response on frontline platinum- based chemotherapy.
Poster Presentation; Abstract #TPS5606, Poster Board #330a, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer (ROC) who have received >3 prior chemotherapy regimens.
Poster Presentation: Abstract #5514, Poster Board #241 Location: Hall A
Poster Discussion: Monday, June 4, 4:45PM – 6:00PM; Location: S100bc

Monday, June 4, 2018, 3:00PM to 4:30PM
TOPACIO/Keynote-162: Niraparib + pembrolizumab in patients (pts) with metastatic triple- negative breast cancer (TNBC), a phase 2 trial.
Oral Presentation; Abstract #1011, 3:36PM, Location: Hall D2

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Monday, June 4th at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting. A reception will begin at 6:00 PM CT, preceding the presentation. During this briefing, TESARO management will provide a business overview and pipeline update and will 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.

The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.

On May 16, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the German Guidelines Program in Oncology (GGPO) has included treatment with Delcath’s CHEMOSAT in the German national treatment guidelines for liver metastases from melanoma (Press release, Delcath Systems, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349370 [SID1234526685]). This inclusion of treatment with CHEMOSAT is in the S3 Guidelines, which represents the highest level within the classification of the guidelines indicating that it is based on evidence and consensus within the German clinical community.

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The GGPO’s update was based on its evaluation of published data on treatment with CHEMOSAT as a loco-regional treatment for melanoma liver metastases. Following this evaluation, and after soliciting additional feedback from the oncology community in Germany, treatment with CHEMOSAT was classified with Evidence Level 1B, indicating the second highest level of evidence. Treatment with CHEMOSAT is the sole therapy classified with this top designation. Other loco-regional therapies previously included in the guidelines have been designated with Evidence Level 4, indicating an absence of clinical trial supporting evidence.

"Inclusion in the GGPO treatment guidelines reflects the steady accumulation of both clinical data and experience built with our therapy in Germany over the last several years," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "Importantly, the guidelines established that treatment with CHEMOSAT is the best supported option for patients with melanoma liver metastases based on current evidence. Through our Clinical Development Program and our commercialization efforts in Germany and other European markets, we are working toward establishing treatment with CHEMOSAT as a first line treatment option for appropriately selected patients.