Atossa Genetics Completes all Dosing and Clinical Visits in its Phase 1 Study of Topical Endoxifen in Men

On June 20, 2018 Atossa Genetics Inc. (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 completed dosing and clinical visits in its Phase 1 study of its proprietary topical Endoxifen in men (Press release, Atossa Genetics, JUN 20, 2018, View Source [SID1234527402]).

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"We are now proceeding to the final stages of this study, which are to complete analysis of blood samples and then collect and analyze the data," commented Steve Quay, Ph.D., M.D., President and CEO of Atossa. "We expect to report preliminary results from the study in the next quarter," added Dr. Quay.

The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of a proprietary topical Endoxifen dosage form over 28 days, as well as to assess safety and tolerability.

Atossa is developing topical Endoxifen for a condition in men called gynecomastia, which is male breast enlargement. According to the Mayo Clinic, 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, suffer from gynecomastia. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. For example, in prostate cancer treatment, testosterone is suppressed with androgen deprivation therapy resulting is higher estrogen levels that usually triggers gynecomastia. 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). There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the daily use of oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated.

Atossa’s Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. Many patients taking tamoxifen, however, do not properly metabolize tamoxifen into therapeutic levels of Endoxifen.

Atossa has completed a comprehensive Phase 1 clinical study using both a topical and an oral formulation of Endoxifen in women. Results from the topical arm of the Phase 1 study in women indicated that the topical formulation was safe, well tolerated and that topical Endoxifen crossed the skin barrier in a dose-dependent fashion.

Topical Endoxifen Opportunities

In addition to gynecomastia, Atossa is also developing its proprietary topical Endoxifen to reduce Mammographic Breast Density (MBD), which has been shown in studies conducted by others to be an independent risk factor for developing breast cancer. To date, 34 U.S. states have enacted laws requiring that findings of MBD be communicated to the patient. And according to the National Cancer Institute, approximately 10 million women in the U.S. have high breast density (BI-RADS level C or D with "D" being the highest). Although oral tamoxifen has been shown to reduce MBD, the benefit-risk ratio is generally not acceptable to most patients. For example, it is estimated that only ~ 2% of women at high-risk of developing breast cancer, including those with MBD, take oral tamoxifen to prevent breast cancer because of the risks of, or actual side-effects of, oral tamoxifen. There is no FDA-approved treatment for MBD.

Atossa is planning a Phase 2 study of its topical Endoxifen in women with MBD. The study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

The primary endpoint of this study is to determine if topical Endoxifen administration results in an individual change in MBD, which will be measured after three and six months. Secondary endpoints are safety and tolerability. The objective of the study is to determine the effect size on MBD between the placebo and active groups, which will permit sample size calculations in a future Phase III study. Enrollment is anticipated to be completed by the end of 2018.

Abbott Hosts Conference Call for Second-Quarter Earnings

On June 20, 2018 Abbott (NYSE: ABT) reported that it will announce its second-quarter 2018 financial results on Wednesday, July 18, 2018, before the market opens (Press release, Abbott, JUN 20, 2018, View Source [SID1234527401]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

ERYTECH to Present at JMP Securities Life Science Conference

On June 20, 2018 ERYTECH Pharma (Euronext Paris:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Chief Executive Officer, Gil Beyen, will present at the JMP Securities Life Science Conference, June 20, 2018 at The St. Regis, New York, in New York City (Press release, ERYtech Pharma, JUN 20, 2018, View Source;p=RssLanding&cat=news&id=2355228 [SID1234527399]).

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Conference Details:

– Conference: JMP Securities Life Science Conference

– Date: June 20, 2018

– Presentation Time: 9:00 AM EDT / 3:00 CET

eidos therapeutics announces pricing of initial public offering

On June 19, 2018 Eidos Therapeutics, Inc. (Nasdaq: EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), reported the pricing of its initial public offering of 6,250,000 shares of common stock at a public offering price of $17.00 per share (Press release, Eidos Therapeutics, JUN 19, 2018, View Source [SID1234576277]). All of the shares are being offered by Eidos. The shares are expected to begin trading on the Nasdaq Global Select Market on June 20, 2018 under the ticker symbol "EIDX." The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Eidos, are expected to be approximately $106.3 million. The offering is expected to close on June 22, 2018, subject to the satisfaction of customary closing conditions. In addition, Eidos has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the initial public offering price.

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J.P. Morgan Securities LLC and BofA Merrill Lynch are acting as joint book-running managers for the offering. Barclays Capital Inc. is also participating as a joint book-running manager.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on June 19, 2018. The offering will be made only by means of a prospectus, copies of which may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by emailing [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (888) 603-5847 or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

RhoVac’s reports positive and constructive response from the European Medicines Agency in the now completed Scientific Advice Procedure

On June 19, 2018, RhoVac AB ("RhoVac") reported that the company has received response from the European Medicines Agency (EMA) on the Scientific Advice Procedure (Press release, RhoVac, JUN 19, 2018, View Source [SID1234555934]). EMA has stated that there are no further preclinical studies needed to be conducted to support the development of the proposed Phase IIb trial and that there is a clear window for early prostate cancer treatment with RhoVac’s drug candidate RV001.

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In alignment with company’s original schedule, RhoVac initiated a Scientific Advice Procedure with EMA in March 2018, to discuss progression of company’s RV001 project into a clinical phase IIb development, and to ensure that RhoVac’s approach was in line with EMA’s guidelines and expectations. Following this, in May, RhoVac was invited to participate at the EMA’s Scientific Advice Working Party’s (SAWP) meeting in London to further discuss the project. Now RhoVac has received the response which was adopted by The Committee for Medicinal Products for Human Use (CHMP) at their meeting 28 – 31 May 2018. The response given by SAWP is based on the questions and supporting documentation RhoVac submitted at the initiation of the procedure.

In summary, EMA has agreed that no further pre-clinical studies are needed to support the proposed phase IIb clinical trial development. EMA has also agreed that the company’s approach in development of a quality specification for RV001 drug candidate was in compliance with relevant regulatory guidelines.

In the response relating to the proposed clinical trial, which targets the early stage of prostate cancer, immediately after radical prostatectomy, EMA agreed that there is a clear window to treat in this stage of the disease using RhoVac’s RV001 drug candidate. Finally, EMA provided valuable advice to further definition of the patient population and on inclusion criteria for the patients to be enrolled in the proposed clinical study.

Comments from RhoVac´s CEO, Anders Ljungqvist

-The Scientific Advice Procedure including the face to face meetings with relevant experts at EMA have been extremely valuable for RhoVac assuring us that we are now in a position to refine and progress our plans for our clinical phase IIb development. To our knowledge, there are no other drugs in development targeting this very early stage of disease progression in prostate cancer while relevant regulatory guidelines for adjuvant treatment in this stage are scarce. The comments and advice from EMA are therefore crucial for the further development of our drug candidate RV001.