Triphenylethylenes

Atossa Therapeutics Receives Approval from Swedish Regulators to Initiate Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density

Retrieved on:

Friday, June 11, 2021

Selective estrogen receptor modulators, Triphenylethylenes, Clinical medicine, Health sciences, Medicine, Drug discovery, Pharmaceutical industry, Preclinical development, Mammography, Endoxifen, Breast cancer, Toxicology

Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

Key Points:

Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.
This is a critical milestone in the development of our oral Endoxifen, commented Steven Quay, M.D., Ph.D., Atossas Chairman and CEO.
In addition to clinical data, regulators will require that we also develop preclinical information including toxicology studies and information about manufacturing oral Endoxifen prior to regulatory approval.
The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability.

Atossa Therapeutics Announces Final Data from Phase 2 Endoxifen Breast Cancer Study Primary Endpoint Met: 65.1% Reduction in Biomarker Ki-67; Secondary Endpoint Met: Endoxifen Safe and Well Tolerated

Retrieved on:

Wednesday, June 9, 2021

Medicine, Health, Selective estrogen receptor modulators, Triphenylethylenes, Endoxifen, Tolerability, Cancer, Breast cancer, Physical examination

Secondary Endpoints Were as Follows:

Key Points:

Secondary Endpoints Were as Follows:
Safety and tolerability: All adverse events were mild and considered related to the study drug.
There were no abnormal laboratory findings (serum chemistry, hematology, coagulation, urinalysis) and no differences in vital signs, physical examinations and ECGs.
Based on these results, Endoxifen was considered safe and well tolerated in this study.
The American Cancer Society (ACS) estimates that in 2021, 281,550women will bediagnosed with breast cancer in the U.S. and 43,600 willdie.

Sermonix Pharmaceuticals Announces Breast Cancer Research Publication of Preclinical Lasofoxifene Study in Endocrine-Resistant Breast Cancer

Retrieved on:

Monday, May 17, 2021

Selective estrogen receptor modulators, Hormones, Organic compounds, Drugs, Triphenylethylenes, Phenols, Progonadotropins, SERM, Estrogen

Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women\xe2\x80\x99s health, menopause and selective estrogen receptor modulator (SERM) therapy.

Key Points:

Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women\xe2\x80\x99s health, menopause and selective estrogen receptor modulator (SERM) therapy.
The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process.
Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena.
Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert\xe2\x80\x99s Pharmaceutical Division.

Atossa Therapeutics to Participate at the Investor Summit Conference and Present to Investors on May 18, 2021

Retrieved on:

Friday, May 14, 2021

Life sciences, Atossa Therapeutics, Biotechnology, Health sciences, Selective estrogen receptor modulators, Triphenylethylenes, Atossa, Biopharmaceutical, Endoxifen

b'SEATTLE, May 14, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, today announced that management will participate at the Investor Summit Conference on May 18, 2021.\nCEO Dr. Steven Quay and Kyle Guse, CFO and General Counsel will deliver a corporate presentation at 8:45am ET on May 18, 2021.\nInvestors can also request a one-on-one meeting with management to be arranged following the conclusion of the conference.\nAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19.

Key Points:

b'SEATTLE, May 14, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, today announced that management will participate at the Investor Summit Conference on May 18, 2021.\nCEO Dr. Steven Quay and Kyle Guse, CFO and General Counsel will deliver a corporate presentation at 8:45am ET on May 18, 2021.\nInvestors can also request a one-on-one meeting with management to be arranged following the conclusion of the conference.\nAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19.
For more information, please visit www.atossatherapeutics.com\nForward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with development plans, any variation between interim, preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa\xe2\x80\x99s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, whether change in mammographic breast density is an approvable end point for oral Endoxifen, and other risks detailed from time to time in Atossa\xe2\x80\x99s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.\n'

Atossa Therapeutics Urges Shareholders to Vote on Proposals Ahead of its Annual Stockholder Meeting May 14, 2021 at 1:00 PM Pacific Time

Retrieved on:

Tuesday, May 11, 2021

Life sciences, Atossa Therapeutics, Biotechnology, Health sciences, Selective estrogen receptor modulators, Triphenylethylenes, Atossa, Biopharmaceutical, Endoxifen

b'SEATTLE, May 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases urges stockholders to vote on proposals put forth in the proxy statement prior to the Company\xe2\x80\x99s May 14, 2021 annual stockholder meeting.\nAtossa stockholder as of the March 24, 2021 record date may vote by calling (833) 786-6488 Monday through Friday 9 a.m. to 9 p.m. Eastern Time.

Key Points:

b'SEATTLE, May 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases urges stockholders to vote on proposals put forth in the proxy statement prior to the Company\xe2\x80\x99s May 14, 2021 annual stockholder meeting.\nAtossa stockholder as of the March 24, 2021 record date may vote by calling (833) 786-6488 Monday through Friday 9 a.m. to 9 p.m. Eastern Time.
Details of the proposals, the stockholder meeting, and additional information on how to vote your shares can be found in the proxy statement, found here .
Holders of approximately 17.3 million shares of Atossa common stock as of the record date have entered into lock-up and voting agreements which require that they vote at the annual stockholder meeting.\nAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19.
For more information, please visit www.atossatherapeutics.com\nForward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with development plans, any variation between interim, preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa\xe2\x80\x99s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, whether change in mammographic breast density is an approvable end point for oral Endoxifen, and other risks detailed from time to time in Atossa\xe2\x80\x99s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.\n'

Atossa Therapeutics Announces Ovarian Cancer Patient has Begun Treatment with Oral Endoxifen under FDA’s Expanded Access Pathway

Retrieved on:

Thursday, April 8, 2021

Drugs, Health, Clinical medicine, Selective estrogen receptor modulators, Triphenylethylenes, Oncology, Hereditary cancers, Tamoxifen, Breast cancer, Ovarian cancer, Endoxifen, Cancer

The FDA previously issued a Safe to Proceed letter under their expanded access pathway, permitting the use of Atossas oral Endoxifen in this patient.

Key Points:

The FDA previously issued a Safe to Proceed letter under their expanded access pathway, permitting the use of Atossas oral Endoxifen in this patient.
The patient has recurrent ovarian cancer and did not tolerate tamoxifen, which is sometimes prescribed for ovarian cancer as well as breast cancer, commented Steven Quay, M.D., Ph.D., Atossas President and CEO.
Under the FDA expanded access program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient.
Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Atossa Therapeutics Announces Year End 2020 Financial Results and Provides Corporate Update

Retrieved on:

Wednesday, March 31, 2021

Endoxifen, Triphenylethylenes

Despite these challenges, 2020 was the year our proprietary Endoxifen programs began to show the potential breadth and depth of its medical and ultimate commercial value.

Key Points:

Despite these challenges, 2020 was the year our proprietary Endoxifen programs began to show the potential breadth and depth of its medical and ultimate commercial value.
Our nasal spray AT-301 being developed for COVID-19 patients to use at home showed encouraging results in preclinical and Phase 1 studies.
For the year ended December 31, 2020, Atossa has no source of sustainable revenue and no associated cost of revenue.
Operating expenses for 2020 consisted of research and development ("R&D") expenses of $6,608,000 and general and administrative ("G&A") expenses of $7,999,000.

Atossa Therapeutics Announces Two-Year Update of FDA-Approved Expanded Access Treatment with Endoxifen

Retrieved on:

Wednesday, February 3, 2021

Selective estrogen receptor modulators, Triphenylethylenes, Atossa Therapeutics, Endoxifen, Cancer, Breast cancer, Health, Branches of biology, Clinical medicine

At the end of 2018, the FDA authorized a single-patient study under its Expanded Access, or compassionate use program, for this breast cancer patient to receive Atossas oral Endoxifen in the window of opportunity between diagnosis of breast cancer and surgery.

Key Points:

At the end of 2018, the FDA authorized a single-patient study under its Expanded Access, or compassionate use program, for this breast cancer patient to receive Atossas oral Endoxifen in the window of opportunity between diagnosis of breast cancer and surgery.
She has now taken Atossas oral Endoxifen for approximately 26 months and is continuing to take oral Endoxifen daily under these authorizations.
We are very encouraged by this patients experience with our Endoxifen over the past two years.
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.

Atossa Therapeutics’ Phase 2 Endoxifen Breast Cancer Study Produces Substantially Positive Results Allowing Study to be Halted Early

Retrieved on:

Tuesday, February 2, 2021

Selective estrogen receptor modulators, Triphenylethylenes, Endoxifen, Drugs, Clinical research, Pharmaceutical industry, Health sciences, Health, Clinical trials

We believe that additional enrollment will not alter these positive results so we are terminating the study early.

Key Points:

We believe that additional enrollment will not alter these positive results so we are terminating the study early.
This saves at least a year on the development time line allowing us to accelerate clinical development in the Unites States.
We look forward to reporting final data from all patients in the study and sharing our continued progress in the development of oral Endoxifen.
The Phase 2 study was conducted on behalf of Atossa by Avance Clinical, a leading Australian CRO.

FDA Approves Novadoz Pharmaceuticals Toremifene and Aminocaproic Acid, Bolstering their Continued Growth in Generics

Retrieved on:

Thursday, December 10, 2020

Drugs, Hormones, Hepatotoxins, Sex hormones, Selective estrogen receptor modulators, Progonadotropins, Triphenylethylenes, Organochlorides, Toremifene, Estrogen, Medroxyprogesterone acetate

Novadoz is the U.S sales and marketing affiliate for MSN's portfolio of finished dosage forms.

Key Points:

Novadoz is the U.S sales and marketing affiliate for MSN's portfolio of finished dosage forms.
The company has commenced shipping of Toremifene, with Aminocaproic Acid to begin shortly.
Toremifene 60mg,an estrogen agonist/antagonist for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor-positive or unknown tumors.
Additionally, the company also manufactures oral solids, liquids, and specialty injectable products in sixty-five markets throughout the world, doing business in the U.S. as Novadoz Pharmaceuticals.