Vulvar cancer

PDS Biotech Reports Median Overall Survival (OS) of 21 Months in Advanced, Refractory Cancer Patients Having Few Remaining Treatment Options and with Reported Historical Survival of 3-4 months

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星期三, 十二月 28, 2022
Cancer, OS, Head, NCI, Infection, Vulvar cancer, ORR, Platinum, Biotechnology, ASCO, AES, Patient, CPI-0610, Fourth grade, PD-L1, FDA, IL-12, CCR, Grade 3, Merck Group, PDSB, HPV, Neck, National Cancer Institute, TGF, American Society of Clinical Oncology, Society, Pharmaceutical industry, CPI

All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment.

Key Points: 
  • All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment.
  • The interim efficacy data (n=50) involves 37 HPV16-positive evaluable patients, including 29 patients who have, in addition, failed treatment with CPIs (CPI refractory).
  • The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

Nykode announces expanded clinical development plan for its lead cancer vaccine VB10.16 in HPV16-positive cancers

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星期二, 十二月 20, 2022
ASA, CET, ORR, Vulvar cancer, Patient, Safety, Cervical cancer, Conference, Pharmaceutical industry

OSLO, Norway, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced an expanded clinical development plan for VB10.16, the Company’s wholly-owned cancer vaccine, for the treatment of HPV16-positive cancers with high unmet need. Nykode Management will host a webcast today, December 20, 2022, to discuss the development plan at 11 a.m. CET (in Norwegian) and 4 p.m. CET/10 a.m. ET (in English).

Key Points: 
  • Nykode Management will host a webcast today, December 20, 2022, to discuss the development plan at 11 a.m. CET (in Norwegian) and 4 p.m. CET/10 a.m.
  • VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies.
  • The drug candidate has reported interim data from VB-C-02, a Phase 2 trial in heavily pre-treated cervical cancer patients.
  • “Today we announce our expanded VB10.16 development plan underlining our confidence in the product candidate’s potential to treat a broad group of HPV-related cancer patients with significant unmet need.

Koya Medical Announces the Addition of Chief Medical Officer Dr. Thomas Maldonado to Their Executive Leadership Team

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星期二, 十二月 27, 2022
Dayspring, Breast cancer, Trauma, Venous insufficiency, Stasis dermatitis, Lymphedema, Education, Neoplasm, Koya, Food, Extremities, Head, Lymphoma, Stanford University School of Medicine, Leg, Uterine cancer, Melanoma, Academic health science centre, FDA, American Cancer Society, Ovarian cancer, Health, Multimedia, Publication, Wound healing, Pain, Vulvar cancer, Movement, Primary lymphedema, Arm, Edema, Vascular and Endovascular Surgery, Lipedema, Research, Regulation of tobacco by the U.S. Food and Drug Administration, Maintenance, Prostate cancer, Pharmaceutical industry

OAKLAND, Calif., Dec. 27, 2022 /PRNewswire/ -- Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced the addition of Dr. Thomas Maldonado as Chief Medical Officer. The addition of Dr. Maldonado further strengthens Koya Medical's clinical advisory board, led by Stanley Rockson, M.D., cardiologist and professor in the Falk Cardiovascular Research Center at Stanford University School of Medicine.

Key Points: 
  • OAKLAND, Calif., Dec. 27, 2022 /PRNewswire/ -- Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced the addition of Dr. Thomas Maldonado as Chief Medical Officer.
  • The addition of Dr. Maldonado further strengthens Koya Medical's clinical advisory board, led by Stanley Rockson, M.D., cardiologist and professor in the Falk Cardiovascular Research Center at Stanford University School of Medicine.
  • has been one of New York City's top vascular surgeons in one of the nation's premier academic medical centers for over two decades.
  • He is regularly featured as Top Doctor by Castle Connolly and has served as president of numerous national and regional vascular societies.

New Study Highlights Poorer Quality of Life, Health Outcomes for African American Women During Menopause

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星期三, 十二月 14, 2022
Health, Consumer, Women, Genetics, Other Health, General Health, Memory, Dizziness, Urinary tract infection, Racism, Menopause, Quality of life, Sleep deprivation, Vulvar cancer, Clumsy, Patient, Menopause (journal), Friends, Inclusion, Collaborative writing, Cardiovascular disease, Tobacco, Personal lubricant, SWAN, Professor, FDA, Vaginitis, Diabetes, Pain, Bleeding, Woman, Overalls, Trauma, Tablet, Flash, Itch, Equity, Breast, Marital status, Mortality, Health, African Americans, Depression, Cognition, Birth control, Pharmaceutical industry, MD

The racial disparity in health conditions is attributed to poverty-induced trauma, lack of access to health insurance, chronic stress and dietary choices.

Key Points: 
  • The racial disparity in health conditions is attributed to poverty-induced trauma, lack of access to health insurance, chronic stress and dietary choices.
  • All are reported to have a significant impact on overall health and have led to the identification of racism as a public health crisis.
  • The cross-sectional screening survey evaluated responses from approximately 16,000 women, 28.1% of whom were African American.
  • Researchers found African American women start menopause earlier, have the highest rates for early onset menopause and experience longer transition periods than other races.

Daré Bioscience Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study

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星期一, 十一月 14, 2022
Cream, Trial of the century, Tablet, Breast cancer, Intravaginal administration, Safety, Disease, Fertility, Risk, Plasma, Prevalence, Organon, Birth, PK, Form, Aromatase, Social media, Vaginal discharge, Survivor, Personal lubricant, Progesterone, Inflammation, Intellectual property, Pain, Tamoxifen, COVID-19, Health, Vulvar cancer, FDA, Failure, SERM, Quality of life, Female, Pharmacokinetics, Bacterial vaginosis, Recurrence, Food, Woman, Oncology, 8-K, Health minister, Dyspareunia, PD, Menopause, Tissue, History, Patient, Birth control, Pharmaceutical industry, VVA, Bayer

SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced topline data from its Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed for the treatment of moderate to severe vulvar and vaginal atrophy. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA. The topline data from the study demonstrated safety and tolerability of DARE-VVA1, as well as improvement in the vaginal cytology parameters and the bothersome vaginal symptoms associated with VVA. DARE-VVA1 has the potential to be the first therapeutic specifically approved for the treatment of VVA in U.S. patients with HR+ breast cancer. There are currently no FDA-approved products labeled for VVA treatment in HR+ breast cancer patients.

Key Points: 
  • We are highly encouraged by the positive topline results of the Phase 1/2 study of DARE-VVA1 as this study is a critical step in developing a potential non-hormonal treatment alternative for VVA, said Dr. Annie Thurman, Medical Director of Dar Bioscience.
  • The Phase 1/2 study evaluated different doses of DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women with VVA.
  • The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluated the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1.
  • Dar plans to submit data from the Phase 1/2 clinical study of DARE-VVA1 for publication in a peer-reviewed publication.

PDS Biotech Announces 100% Clinical Response in Cervical Cancer Patients in Preliminary Data from IMMUNOCERV Phase 2 Clinical Trial

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星期一, 十一月 14, 2022
Trial of the century, Communication, Survival, Neck, Lymph, National Cancer Institute, Type 1, CT scan, Cancer, Mayo Clinic, Disease, Radiation, PDS, Toxicity, Immunotherapy, Treatment, Vaccine, Cervical cancer, Blood, Partnership, PET, University, Neoplasm, Research, Nature, Society, MD Anderson Cancer Center, Biotechnology, COVID-19, Merck & Co., Vulvar cancer, Warfarin necrosis, NCI, Merck, MRI, Human, CD8, Sharp, Nominal interest rate, Clinical professor, Therapy, FIGO, CRT, CPI, Gamma ray, III, Risk, Infection, Merck Sharp & Dohme Federal Credit Union, PDSB, Positron emission tomography, CR, Head, SITC, Pharmaceutical industry, Medical imaging, Patient

FLORHAM PARK, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that updated clinical data from the ongoing IMMUNOCERV Phase 2 clinical trial was presented during a poster session on November 11 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022). These data expand upon results detailed in the abstract submitted to SITC 2022 that was released to the public on November 7.

Key Points: 
  • This includes 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).
  • 100% (9/9) of patients treated with the combination of PDS0101 and CRT had a clinical response with tumor shrinkage >60% at mid-point evaluation by MRI.
  • We look forward to the continued advancement of the IMMUNOCERV Phase 2 clinical trial and the opportunity to report updated data during 2023.
  • A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center.

PDS Biotech Announces Presentation of Preliminary PDS0101 Efficacy, Safety, and Immunology Data at Society for Immunotherapy of Cancer (SITC 2022)

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星期一, 十一月 7, 2022
National Cancer Institute, Neck, Population, Sharp, PDSB, Cervical cancer, Clinical trial, National, Partnership, University, SEC, SITC, Company, Merck, CT scan, GLOBE, Radiation, NCI, Vulvar cancer, Immunotherapy, Clinical professor, CEO, CR, CRT, Forward-looking statement, Vaccine, CPI, Society, Cancer, Blood, PET, Research, Biotechnology, Toxicity, Risk, Neoplasm, PDS, Merck & Co., COVID-19, Nature, Review, Head, Infection, Positron emission tomography, Goal, Mayo Clinic, Therapy, Lymph, Safety, Trial of the century, Nasdaq, MD Anderson Cancer Center, Merck Sharp & Dohme Federal Credit Union, Center, Communication, Pharmaceutical industry, Medical imaging, Patient

FLORHAM PARK, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) being held November 8-12, 2022 in Boston. PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.

Key Points: 
  • PDS0101 is PDS Biotechs lead candidate being developed as a potential treatment for HPV-positive cancers.
  • 8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
  • The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
  • PDS Biotechs lead candidate, PDS0101, combines the utility of the Versamune platform with targeted antigens in HPV-expressing cancers.

PDS Biotech Announces Abstract Demonstrating Versatility of the Versamune® Platform in Oncology Accepted for Presentation at AACR Special Conference on Tumor Immunology and Immunotherapy

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星期一, 十月 17, 2022
American Association for Cancer Research, Lung, Infection, Colon, Communication, Therapy, SEC, Head, Review, Conference, MUC1, AML, Vaccine, Neck, Neoplasm, Patient, Vulvar cancer, Research, Twitter, Cancer, Immunotherapy, Nasdaq, Risk, Technology, Hepatitis C alternative reading frame stem-loop, Goal, Immune system, Company, AACR, Prostate, Alternative, TARP, PDSB, American Association, Nature, GLOBE, Forward-looking statement, Peptide, PDS, COVID-19, Biotechnology, Breast, Pharmaceutical industry

The AACR Tumor Immunology and Immunotherapy Conference is being held October 21-24, 2022, in Boston.

Key Points: 
  • The AACR Tumor Immunology and Immunotherapy Conference is being held October 21-24, 2022, in Boston.
  • Versamune is PDS Biotechs novel investigational T cell activating platform designed to stimulate a precise immune system response to cancer-specific proteins.
  • The research accepted for presentation at the AACR Tumor Immunology and Immunotherapy Conference highlights this important versatility of the platform and, specifically, the rationale for our PDS0102 and PDS0103 programs, commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech.
  • Versamune is a registered trademark and Infectimune is a trademark of PDS Biotechnology.

PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers

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星期二, 十月 11, 2022
Merck, Therapy, Head, Merck & Co., Vulvar cancer, National, University of Texas at Austin, Survival, Infection, Communication, Population, ASCO, Twitter, Cancer, Merck Sharp & Dohme Federal Credit Union, Company, National Cancer Institute, PDSB, CCR, Nature, GLOBE, Clinical trial, HPV, Biotechnology, Risk, Review, Vaccine, Neck, Research, Goal, Trial of the century, CPI, Cervical cancer, Immunotherapy, University, NCI, SEC, Sharp, Neoplasm, Patient, AES, Nasdaq, Partnership, Safety, Merck Group, MD Anderson Cancer Center, Forward-looking statement, Center, PDS, COVID-19, Institute, Pharmaceutical industry

The triple combination is being studied in CPI-nave and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.

Key Points: 
  • The triple combination is being studied in CPI-nave and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.
  • Highlights of the expanded interim data are as follows:
    Survival data: 66% (19/29) of HPV 16-positive CPI refractory patients in the cohort were alive at a median follow up of 16 months.
  • PDS Biotechs lead candidate, PDS0101, combines the utility of the Versamune platform with targeted antigens in HPV-positive cancers.
  • A third phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

Marsai Martin Teams Up with the Foundation for Women's Cancer to Raise Awareness of Gynecologic Cancer as Move4Her Celebrity Ambassador

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星期二, 八月 2, 2022
Message, Oncology nursing, SGO, Universal, Diagnosis, Cancer, Education, Awareness, Walking, FWC, Physician, Society of Gynecologic Oncology, Twitter, Instagram, Foundation, Woman, Memorial Sloan Kettering Cancer Center, Research, Health, Ginger, Risk, Cervical cancer, Movement, Society, Vulvar cancer, MD, Patient, ABC, Gynecologic Oncology (journal), Black-ish, Birth control, Medicine, Facebook

CHICAGO, Aug. 2, 2022 /PRNewswire-PRWeb/ -- The Foundation for Women's Cancer (FWC) is pleased to announce that Marsai Martin, known for her roles in the ABC sitcom Black-ish and Universal's Little, will be a Celebrity Ambassador for Move4Her. Now in its third year, Move4Her is the FWC's primary fundraising event to power research and awareness of the five gynecologic (gyn) cancers – cervical, ovarian, uterine/endometrial, vaginal or vulvar cancer. For the first time, this year Move4Her will be a Month of Movement held throughout September for Gynecologic Cancer Awareness Month.

Key Points: 
  • Actress Marsai Martin, whose grandmother battled cervical cancer, partners with the Foundation for Women's Cancer for its annual fundraising initiative Move4Her to power research and awareness of gynecologic cancers.
  • CHICAGO, Aug. 2, 2022 /PRNewswire-PRWeb/ -- The Foundation for Women's Cancer (FWC) is pleased to announce that Marsai Martin, known for her roles in the ABC sitcom Black-ish and Universal's Little, will be a Celebrity Ambassador for Move4Her.
  • For the first time, this year Move4Her will be a Month of Movement held throughout September for Gynecologic Cancer Awareness Month.
  • The Foundation for Women's Cancer (FWC) is dedicated to increasing public awareness of gynecologic cancer risk, prevention, early detection, and optimal treatment.