Progonadotropins

Prostate Cancer Clinical Landscape Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 15, 2021
Health, Oncology, Anatomy, Organ systems, Prostate cancer, Chemical compounds, Nonsteroidal antiandrogens, Progonadotropins, Histopathology, Enzalutamide, MCRPC, Prostate, Cancer, Prostvac

In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.

Key Points: 
  • In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.
  • Prostate cancer drugs, on average, take 9.0 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
  • Pfizer's next-generation androgen receptor (AR) inhibitor Xtandi is the market leader in prostate cancer due to its established efficacy across prostate cancer segmentations and a lack of near-term generic competition.
  • Future expansion opportunities include potential use in combination with PARP inhibitors Talzenna or Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients.

Veru Enrolls First Patient in Phase 3 VERACITY Clinical Trial of Sabizabulin (VERU-111) in Metastatic Castration Resistant and Androgen Receptor Targeting Agent Resistant Prostate Cancer

Retrieved on: 
Friday, June 25, 2021
Organ systems, Clinical medicine, Chemical compounds, Prostate cancer, Nonsteroidal antiandrogens, Progonadotropins, Histopathology, Androgen receptor, Enzalutamide, James L. Gulley

The Phase 3 VERACITY clinical trial is an open label, randomized (2:1), multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy nave men with metastatic castration resistant prostate cancer who have progressed on at least one androgen receptor targeting agent.

Key Points: 
  • The Phase 3 VERACITY clinical trial is an open label, randomized (2:1), multicenter registration study to evaluate the efficacy and safety of sabizabulin 32mg oral daily dosing versus an alternative androgen receptor targeting agent for the treatment of chemotherapy nave men with metastatic castration resistant prostate cancer who have progressed on at least one androgen receptor targeting agent.
  • Unfortunately, advanced prostate cancer patients receiving androgen receptor targeting agents in combination with standard ADT will eventually have tumor progression.
  • Verus prostate cancer pipeline includes: sabizabulin, an oral, first-in-class, new chemical entity that targets the cytoskeleton disruptor which in prostate cancer also disrupts the transport of the androgen receptor.
  • A Phase 3 VERACITY clinical trial evaluating the efficacy and safety of sabizabulin in approximately 245 men for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer is enrolling.

Veru Enrolls First Patient in Phase 2 Clinical Trial of VERU-100, Novel Long-acting GnRH Antagonist Decapeptide Injection Formulation, for the Treatment of Hormone Sensitive Advanced Prostate Cancer

Retrieved on: 
Thursday, June 10, 2021
Hormones, Endocrine system, Organ systems, Sex hormones, Enones, Testosterone, Prostate cancer, Progonadotropins, Gonadotropin-releasing hormone antagonist, Androgen deprivation therapy, Gonadotropin-releasing hormone, Gonadotropin-releasing hormone agonist

The ADT market is well-established for advanced prostate cancer and is estimated to be approximately $2.8 billion worldwide.

Key Points: 
  • The ADT market is well-established for advanced prostate cancer and is estimated to be approximately $2.8 billion worldwide.
  • Androgen deprivation therapy using a GnRH antagonist is preferred because castration occurs rapidly within a week with no surges or flares in testosterone levels.
  • Unfortunately, there are no GnRH antagonist depot injection formulations for ADT approved by FDA for treatment beyond a one-month duration.
  • The Phase 2 clinical trial is an open label, multicenter, dose finding study evaluating the efficacy and safety of subcutaneous injected doses of VERU-100 in 35 men with hormone sensitive advanced prostate cancer.

Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI® for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization

Retrieved on: 
Thursday, May 27, 2021
Hormones, Sex hormones, Organ systems, Progonadotropins, Fertility medicine, Antiandrogens, Antiestrogens, Gonadotropin-releasing hormone agonist, Gonadotropin-releasing hormone, Prostate cancer

We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.

Key Points: 
  • We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.
  • CAMCEVI 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.
  • "Camcevi 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer," Said Chrys Kokino, U.S. President Accord BioPharma specialty products.
  • CAMCEVI is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or the components of CAMCEVI.

Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI® for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization

Retrieved on: 
Thursday, May 27, 2021
Hormones, Sex hormones, Organ systems, Progonadotropins, Fertility medicine, Antiandrogens, Antiestrogens, Gonadotropin-releasing hormone agonist, Gonadotropin-releasing hormone, Prostate cancer

We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.

Key Points: 
  • We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.
  • CAMCEVI 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.
  • "Camcevi 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer," Said Chrys Kokino, U.S. President Accord BioPharma specialty products.
  • CAMCEVI is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or the components of CAMCEVI.

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.

Veru Announces the Presentation of Positive Phase 2 Clinical Data of Enobosarm in AR+ER+HER2- Metastatic Breast Cancer Patients that Have Progressed on Estrogen Blocking Agents and CDK 4/6 Inhibitor at the ESMO Breast Cancer Congress 2021

Retrieved on: 
Wednesday, May 5, 2021
Chemical compounds, Branches of biology, Drugs, Protein kinase inhibitors, Piperazines, Aromatase inhibitors, Progonadotropins, Cyclin-dependent kinase 4, Oncogenes, Letrozole, Breast cancer, Nonsteroidal

Patients who have metastatic breast cancers that progress on estrogen receptor blocking agent and CDK4/6 inhibitor therapies are a group in which we need to define the most optimal drug treatment.

Key Points: 
  • Patients who have metastatic breast cancers that progress on estrogen receptor blocking agent and CDK4/6 inhibitor therapies are a group in which we need to define the most optimal drug treatment.
  • Enobosarm is in clinical development for the treatment of metastatic ER+HER2- breast cancer patients whose disease has progressed after treatment with a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor.
  • In the U.S., FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies.
  • An NDA was filed by FDA in April 2021 with a PDUFA date in December 2021.

Astellas' XTANDI™ (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer

Retrieved on: 
Tuesday, May 4, 2021
Organic compounds, Chemical compounds, Prostate cancer, Organ systems, Nonsteroidal antiandrogens, Progonadotropins, Benzamides, Nitriles, Enzalutamide, Astellas Pharma, Abiraterone acetate, Stampede

b'TOKYO, May 4, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the European Commission (EC) has approved an additional indication for the oral once-daily therapy XTANDI (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).

Key Points: 
  • b'TOKYO, May 4, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the European Commission (EC) has approved an additional indication for the oral once-daily therapy XTANDI (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).
  • "This new indication for enzalutamide provides men with mHSPC a much-needed, additional therapy option earlier in their treatment journey.
  • We look forward to working with health authorities across Europe to ensure men with mHSPC have access to enzalutamide as soon as possible.
  • Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard.

Zenith Epigenetics Announces Dosing of First mCRPC Patient with a Combination of ZEN-3694 + Merck’s Immune Check Point Inhibitor KEYTRUDA

Retrieved on: 
Monday, March 15, 2021
Prostate cancer, Health sciences, Organic compounds, Chemical compounds, Nonsteroidal antiandrogens, Progonadotropins, MCRPC, Enzalutamide, Therapy, Prostvac

ZEN-3694, the Companys lead therapeutic compound, is being developed for epigenetic combination therapies in multiple oncology indications.

Key Points: 
  • ZEN-3694, the Companys lead therapeutic compound, is being developed for epigenetic combination therapies in multiple oncology indications.
  • This clinical trial will evaluate the aforementioned triple combination therapy in mCRPC patients that have become resistant to a 1stline ARSI therapy.
  • Zenith Capital Corp. is a biotechnology investment company originally spun out of Resverlogix Corp. (TSX: RVX) in 2013.
  • The lead compound, ZEN-3694, is in clinical development for:
    Metastatic Castration Resistant Prostate Cancer (mCRPC) in combination with androgen receptor inhibitor, XTANDI

Global Selective Estrogen Receptor Degrader SERD Inhibitors Drug Market Clinical Trials Report 2025

Retrieved on: 
Monday, March 15, 2021
Hormones, Endocrine system, Organ systems, Antiestrogens, Hepatotoxins, Prolactin releasers, Estranes, Progonadotropins, Selective estrogen receptor degrader, Estrogen receptor, Estrogen, Breast cancer

Selective estrogen receptor degrader therapy market has led to the overall fragmentation of the market towards the applications of the market that it has distributed in such short period of time.

Key Points: 
  • Selective estrogen receptor degrader therapy market has led to the overall fragmentation of the market towards the applications of the market that it has distributed in such short period of time.
  • The overall combined shift led by the selective estrogen receptor degrader therapy market perhaps is representing a major breakthrough that has pushed the patients to receive real treatment for their local or advanced breast cancer.
  • As per "Selective Estrogen Receptor Degrader (SERDs) Market, Dosage, Price & Clinical Trials Insight 2025" report findings, it is estimated that the market is capable of offering advancements in the medical treatment with its ability to target the major receptors that are however important for regulating the growth of the cancer cells.
  • The current selective estrogen receptor degrader therapy market landscape is estimated to grow even more stronger and cause a steep growth in market size in the next few years.