Tamoxifen

Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, March 28, 2024
Cream, Dysmenorrhea, Patient, History, Bacteria, G&A, Vaginal discharge, IND, Bayer, Human development, Investment, Diclofenac, NSAID, Menstruation, Research, Hormone, Bacterial vaginosis, P-value, Webcast, SAN, NIH, Trial of the century, Pleasure, Woman, Breast cancer, Safety, Pharmacokinetics, Food, Development, Menopause, Nonsteroidal anti-inflammatory drug, HR, ARPA, VVA, Tamoxifen, FDA, Attention, CRADA, Female, Dyspareunia, Ecosystem, NICHD, Bangladesh Technical Education Board

SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.

Key Points: 
  • In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
  • Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
    Cash and cash equivalents: $10.5 million at December 31, 2023.
  • Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.

Atossa Therapeutics Provides Five-Year (Z)-Endoxifen Treatment Update on FDA-Approved "Expanded Access" Program for a U.S. Breast Cancer Patient

Retrieved on: 
Tuesday, March 19, 2024
Diagnosis, Growth, Ki-67, Neoadjuvant therapy, Mammography, Cancer, Expanded access, Woman, Neoplasm, Therapy, Breast cancer, CYP2D6, Safety, Axis, Osteoporosis, Hot, Recurrence, Tamoxifen, FDA, Enzyme inhibitor, PR, Pharmaceutical industry

Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

Key Points: 
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • Over five years of adjuvant treatment, her daily (Z)-endoxifen treatment has been well tolerated, and there were no vasomotor symptoms commonly associated with standard of care adjuvant pharmaceuticals.
  • She remains cancer-free today and we are grateful to have been able to help her with a difficult treatment problem.”
    Diagnosis.
  • Under the FDA Expanded Access IND program, the use of Atossa's proprietary (Z)-endoxifen is restricted to this patient only.

Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Wednesday, March 20, 2024
Research, General Health, Pharmaceutical, Oncology, Public Relations, Investor Relations, Clinical Trials, Science, Biotechnology, Communications, Practice Management, Other Science, Health, Fulvestrant, Carcinoma, Progression-free survival, Patient, JAMA Oncology, Pharming, Biomarker, CDK, Letrozole, IND, Triple-negative breast cancer, Puma Biotechnology, Cancer, Paclitaxel, Breast cancer, Anastrozole, Tamoxifen, FDA, Food, Pharmaceutical industry

This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.

Key Points: 
  • This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.
  • Puma plans to initiate this trial in the second half of 2024.
  • Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial.
  • We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Daré Bioscience Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1, a Novel Intravaginal Formulation of Tamoxifen for Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy Associated with Menopause

Retrieved on: 
Thursday, December 7, 2023
Personal lubricant, Quality of life, Food, Woman, IND, Breast cancer, HR, FDA, Prevalence, Menopause, Syndrome, Dyspareunia, SAN, Inflammation, VVA, History, Tamoxifen, Pharmaceutical industry

With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1.

Key Points: 
  • With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1.
  • VVA is an inflammation and thinning of the vaginal epithelium due to chronic hypo-estrogenism, which is the reduction in levels of circulating estrogen.
  • Typical symptoms include vaginal dryness, itching, burning, and painful intercourse (dyspareunia), adversely impacting quality of life.
  • Products containing estrogen are commonly used to treat VVA but some women cannot or choose not to use these products, including those with a history of hormone-receptor positive (HR+) breast cancer.

Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Paclitaxel, Tamoxifen, CDK, Food, Letrozole, Carcinoma, Fulvestrant, Progression-free survival, Doctor of Pharmacy, Breast cancer, Patient, Anastrozole, PFS, BID, FDA, Puma Biotechnology, DOR, DCR, ORR, PUMA, Phase, Biomarker, Cancer, Pharmaceutical industry, Birth control

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).
  • The Company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.
  • “There continues to be a need for new drugs for the treatment of metastatic HER2-negative, hormone receptor-positive breast cancer,” said Alvin Wong, PharmD, Chief Scientific Officer of Puma Biotechnology.
  • “The clinical trials of alisertib to date in HER2-negative, hormone receptor-positive metastatic breast cancer have demonstrated alisertib’s potential clinical benefit in this patient population, and we look forward to initiating the PUMA-ALI-1201 trial in 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Daré Bioscience Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, November 9, 2023
Cream, Female, FDA, Bacterial vaginosis, Research, Human development, Trial of the century, Cooperative research and development agreement, Vaginal discharge, Food, Hot, Organon, Human services, Eunice Kennedy Shriver National Institute of Child Health and Human Development, G&A, Progesterone, Phase 3, Quarter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Call, Development, NICHD, Webcast, Clinical trial, ID, Tamoxifen, FSAD, Bacteria, Hormone, NIH, Woman, Safety, Office of Inspector General, U.S. Department of Health and Human Services, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Patient, Bangladesh Technical Education Board, Pharmaceutical industry, Birth control, Bayer, Conference

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2023 and provided a company update.

Key Points: 
  • ET
    SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2023 and provided a company update.
  • XACIATO™ provides a new therapeutic option for the millions of women suffering from bacterial vaginosis in the U.S.
  • Financial Highlights for the Quarter ended September 30, 2023
    Cash and cash equivalents: $13.8 million at September 30, 2023.
  • Daré will host a conference call and live webcast today, November 9, 2023, at 4:30 p.m. Eastern Time to review financial results for the quarter ended September 30, 2023 and to provide a company update.

Senti Bio Announces Multiple Data Presentations at the Society for Immunotherapy of Cancer Annual Meeting

Retrieved on: 
Tuesday, October 31, 2023
Society for Immunotherapy of Cancer, Biotechnology, Gene, Doctor of Philosophy, Factorization of polynomials, Logic gate, SITC, SNTI, Immunotherapy, Cell death, Science, NK, Tamoxifen, Cancer, Inverter (logic gate), Molecular logic gate, Annual general meeting, Safety, Society, Bluerock Wildland Provincial Park, David N. Senty, SAN, Mobile phone, Vaccine, MD

SOUTH SAN FRANCISCO, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced four poster presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held November 1-5, 2023, in San Diego, CA.

Key Points: 
  • “This continues to be a definitive year for Senti with multiple presentations across multiple medical and scientific venues,” said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio.
  • “The four posters at this year’s SITC meeting highlight the breadth and modularity of our platform.
  • Senti’s Bio proprietary Logic Gating can help design cell therapies that address more tumor types by increasing the therapeutic window.
  • Senti Bio has developed a robust platform for high-throughput promoter discovery that leverages both pooled library screening and automated end-to-end clonal screening.

Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group

Retrieved on: 
Monday, October 30, 2023
DCIS, FDA, NCI, Atossa, Testosterone, Biomarker, SERM, MD, Breast disease, Growth, Ductal carcinoma, Disease, Risk, Tamoxifen, National Cancer Institute, Breast cancer, SAN, Woman, Safety, Anastrozole, Patient, Toxicity, Breast, Pharmaceutical industry, Birth control

SAN FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announces the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics (Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. 

Key Points: 
  • Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer, which means that patients are often over-treated with invasive procedures.
  • A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery.
  • RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting.
  • The three collaborators for this trial, Atossa Therapeutics, Havah Therapeutics, and Stemline, all aim to find alternative solutions for DCIS patients and are providing different agents for assessment.

Sermonix Pharmaceuticals Announces Results of ELAINE-1 Exploratory Analysis Evaluating Effect of Patient Characteristics on Baseline Genitourinary Symptoms

Retrieved on: 
Monday, October 2, 2023
North American Menopause Society, Therapy, Progression-free survival, International Menopause Society, ESR1, ESMO, Life, Fulvestrant, Quality of life, Woman, NAMS, Mutation, Oncology, European Society for Medical Oncology, Goldfarb, Eli Lilly, Congress, Patient, Memorial Sloan Kettering Cancer Center, Annual general meeting, Diagnosis, Poster, AI, Menopause, Tamoxifen, Breast cancer, Birth control, Pharmaceutical industry, COLUMBUS

Prior adjuvant tamoxifen was associated with more severe vaginal/vulvar symptoms, as was a longer total duration of AI use in both adjuvant and metastatic settings.

Key Points: 
  • Prior adjuvant tamoxifen was associated with more severe vaginal/vulvar symptoms, as was a longer total duration of AI use in both adjuvant and metastatic settings.
  • Duration of prior AI in the adjuvant setting alone did not impact baseline vaginal or vulvar symptoms.
  • “As women are living longer with ER+ metastatic disease, it is extremely important to treat their symptoms to improve quality of life.
  • A secondary exploratory analysis showed numeric improvements in vaginal/vulvar symptoms with lasofoxifene versus fulvestrant (Goldfarb et al., 2023, ISSWSH).

Daré Bioscience to Present at The Menopause Society 2023 Annual Meeting

Retrieved on: 
Wednesday, September 20, 2023
University, North American Menopause Society, Menopause, Safety, Indianapolis Marriott Downtown, NAMS, University of Adelaide, University of Western Australia, Pharmacokinetics, SAN, Treatment, Poster, Diabetes, Tamoxifen, Medical research

SAN DIEGO, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE ), a leader in women’s health innovation, today announced that Dr. Andrew Goldstein, Daré Medical Advisor, will present at the 2023 Annual Meeting of The Menopause Society (formerly known as The North American Menopause Society, or NAMS) taking place September 27-30, 2023 at the Marriott Downtown in Philadelphia, PA. Additionally, three poster presentations relating to two of Daré’s investigational products designed to address common menopausal symptoms will be shared at the meeting.

Key Points: 
  • SAN DIEGO, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE ), a leader in women’s health innovation, today announced that Dr. Andrew Goldstein, Daré Medical Advisor, will present at the 2023 Annual Meeting of The Menopause Society (formerly known as The North American Menopause Society, or NAMS) taking place September 27-30, 2023 at the Marriott Downtown in Philadelphia, PA. Additionally, three poster presentations relating to two of Daré’s investigational products designed to address common menopausal symptoms will be shared at the meeting.
  • Pharmacokinetics, Safety and Preliminary Pharmacodynamic Evaluation of DARE-VVA1: A Soft Gelatin Capsule containing Tamoxifen for the Treatment of the Genitourinary Syndrome of Menopause
    2.
  • PARC Clinical Research and Robinson Research Institute, University of Adelaide, Adelaide, Australia
    3.
  • Keogh Institute for Medical Research, Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, University of Western Australia, Nedlands, Australia