On May 16, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that seven abstracts highlighting progress in the Rubraca preclinical research and clinical development program will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Clovis Oncology, MAY 16, 2018, View Source [SID1234526702]).

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The accepted abstracts include additional data from the phase 3 ARIEL3 clinical trial, as well as summaries of ongoing preclinical research and multiple clinical trials in which Rubraca is being studied as monotherapy and in combination in cancer types including ovarian, bladder, prostate and breast cancers.

"Rubraca has demonstrated its ability to reduce the risk of disease progression following platinum-based chemotherapy for women with advanced ovarian cancer, and our team is dedicated to fully exploring the potential of this molecule as a new treatment option for patients being treated for other cancer types where PARP inhibitors have shown encouraging results," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing updates on the progress of our clinical development program at ASCO (Free ASCO Whitepaper) 2018."

The four Clovis Oncology-sponsored abstracts accepted for presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting comprise:

Abstract TPS4592 (Poster 415a) – ATLAS: A phase 2, open-label study of rucaparib in patients (pts) with locally advanced or metastatic urothelial carcinoma (mUC).

Presenter: Petros Grivas, MD, PhD, University of Washington
Session: Genitourinary (Nonprostate) Cancer
Date/Time: Saturday, June 2, 8:00 -11:30 a.m. CT
Location: Hall A
Abstract 5537 (Poster 264) – Evaluation of rucaparib in platinum-sensitive recurrent ovarian carcinoma (rOC) in patients (pts) with or without residual bulky disease at baseline in the ARIEL3 study.

Presenter: Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Abstract 5545 (Poster 272) – Exploratory analysis of percentage of genomic loss of heterozygosity (LOH) in patients with platinum-sensitive recurrent ovarian carcinoma (rOC) in ARIEL3.

Presenter: Ana Oaknin, MD, PhD, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO)
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Abstract 5582 (Poster 309) – Efficacy and immune modulation of the tumor microenvironment with the combination of the PARP inhibitor rucaparib and CD122-biased agonist NKTR-214.

Presenter: Andrew Simmons, PhD, Clovis Oncology
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Additionally, three additional collaborator and investigator sponsored abstracts investigating Rubraca in metastatic breast and prostate cancers are also being presented:

Abstract TPS1112 (Poster 187a) – An open-label, phase II study of rucaparib, a PARP inhibitor, in HER2- metastatic breast cancer patients with high genomic loss of heterozygosity.

Presenter: Anne Patsouris, Institute of West Cancerology Paul Papin
Session: Breast Cancer – Metastatic
Date/Time: Saturday, June 2, 8:00-11:30 a.m. CT
Location: Hall A
Abstract TPS5095 (Poster 317b) – Phase II trial of rucaparib (without ADT) in patients with metastatic hormone-sensitive prostate cancer harboring germline DNA repair gene mutations (TRIUMPH).

Presenter: Mark Christopher Markowski, MD, PhD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Session: Genitourinary (Prostate) Cancer
Date/Time: Saturday, June 2, 1:15-4:45 p.m. CT
Location: Hall A
Abstract TPS3126 (Poster 327b) – An open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD).

Presenter: Karim Fizazi, MD, PhD, Gustave Roussy
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00-11:30 a.m. CT
Location: Hall A
Clovis Oncology’s Rubraca posters will be available online at View Source as of the time they are presented at the meeting.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved 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. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S.

On May 16, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that the Company will present on the design of its Phase 1 clinical trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Syros Pharmaceuticals, MAY 16, 2018, View Source [SID1234526718]).

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The Phase 1 trial is currently enrolling advanced solid tumor patients in the dose-escalation portion of the trial, with planned expansion cohorts to further evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Syros expects to open the expansion phase of the trial in mid-2018 and to report data from the dose-escalation portion of the trial in the fourth quarter of 2018.

Details on the presentations are as follows:

Date & Time: Monday, June 4, 8:00 a.m. – 11:30 a.m. CDT
Presentation Title: Trial Design of a First-in-Human Phase 1 Evaluation of SY-1365, a First-in-
Class Selective CDK7 Inhibitor, with Initial Expansions in Ovarian and Breast Cancers
Session Title: Developmental Therapeutics—Clinical Pharmacology and Experimental
Therapeutics
Presenter: Geoffrey Shapiro, M.D., Ph.D., Dana-Farber Cancer Institute
Abstract Number: TPS2600
Location: McCormick Place, Hall A

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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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 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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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 15, 2018 Atossa Genetics Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it has received a second positive interim safety review on its Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement), a common condition in patients being treated for prostate cancer (Press release, Atossa Genetics, MAY 15, 2018, View Source [SID1234526610]). The Independent Safety Committee reviewed the blinded data generated from the second group in the study (eight subjects) and concluded that the study may advance to the final dosing level.

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Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa commented, "We can now advance to the next level of the study which is to escalate the dosage in the third and final cohort of subjects as we continue to monitor safety and tolerability in the first and second cohorts of the study. We plan to complete enrollment this quarter and announce results from the study next quarter," added Dr. Quay.

The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is to assess the pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.

About Gynecomastia

Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).

According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti-anxiety medications; cancer treatments (chemotherapy), and some heart medications. Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking these important medications.

There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.