On January 7, 2015 Medivation, Inc. (NASDAQ: MDVN) and NanoString Technologies, Inc., (NASDAQ: NSTG) reported they have entered into a collaboration, together with Astellas Pharma Inc., to pursue the translation of a novel gene expression signature algorithm from Medivation into a companion diagnostic assay using NanoString’s nCounter Dx Analysis System (Press release, Medivation, JAN 7, 2016, View Source [SID:1234508684]). Under the terms of the collaboration agreement, NanoString will be responsible for developing and validating the diagnostic test and, if the parties thereafter determine to proceed, NanoString would also be responsible for seeking regulatory approval for and commercializing the diagnostic test. NanoString is eligible to receive up to $22 million for technology access, near-term milestones and development funding, in addition to other potential undisclosed downstream payments.

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Under the Collaboration Agreement, NanoString will modify its PAM50-based Prosigna Breast Cancer Assay for potential use as a companion diagnostic test for enzalutamide for triple negative breast cancer. The modified test will be based upon data from a Phase 2 trial conducted by Medivation and Astellas that evaluated enzalutamide in patients with triple negative breast cancer.

"We are excited about the partnership with NanoString given their expertise in diagnostic development and that the Prosigna assay has regulatory clearance in the U.S. and European Union," said Amy Peterson, M.D., vice president, clinical development at Medivation. "Triple negative breast cancer has no recognized target and standard therapy is therefore cytotoxic chemotherapy. This diagnostic has the potential to identify patients with triple negative breast cancer appropriate for treatment with enzalutamide. We look forward to generating additional clinical data that validates this potential in a severely underserved patient population."

"We’re excited to work with Medivation and Astellas to translate their discoveries and Phase 2 findings into a potential label expansion for enzalutamide with a companion diagnostic," said Brad Gray, president and chief executive officer of NanoString Technologies. "We’re also pleased to have the opportunity to leverage our PAM50-based Prosigna breast cancer franchise, potentially expanding its role in informing breast cancer treatment decisions and enhancing the description of the intrinsic biology of breast cancer to aid in therapeutic treatment decisions. Furthermore, we believe this collaboration will provide additional validation of our nCounter Dx Analysis System as the platform-of-choice for development of multiplexed companion diagnostic assays."

XTANDI (enzalutamide) capsules is currently approved for the treatment of metastatic castration-resistant prostate cancer; it is not approved for use in women and is contraindicated in women who may become pregnant. Enzalutamide is not approved for women with advanced triple negative breast cancer. See Important Safety Information below.

About the Prosigna Breast Cancer Prognostic Gene Signature Assay
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

In the United States, the Prosigna Assay has 510K clearance and is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes. For more information, please visit www.prosigna.com.

On January 7, 2016 C4 Therapeutics reported that it has launched from Dana-Farber Cancer Institute with the closing of a $73 million Series A round of financing (Press release, C4 Therapeutics, JAN 7, 2016, View Source;series-a.html [SID:1234508695]).

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The Company is developing novel treatments in the field of targeted protein degradation using proprietary Degronimid technology. The Degronimid platform technology was pioneered since 2010 by researchers in the Bradner Lab at Dana-Farber Cancer Institute and described in a seminal paper published in the Journal Science in June 2015. Degronimids represent a new class of small molecule targeted protein degradation (TPD) therapeutics that target disease-causing proteins and facilitate their rapid destruction and clearance from the cell. The Company has executed a license agreement with Dana-Farber that provides worldwide exclusivity for all applications of the Degronimid technology.

The groundbreaking Degronimid platform utilizes an innovative, all-chemical solution for potent, targeted and rapid protein degradation. Degronimids are novel chemical adapters that are conjugated with selective small molecules designed to recruit the cell’s ubiquitin/proteasome system (UPS) in order to "naturally" degrade targeted proteins. Degronimids offer a promising solution for the removal of previously undruggable proteins, including those that are known to develop resistance to inhibitors.

"We are building a word-class team of pioneers in the field of targeted protein degradation who are dedicated to our mission of developing a new class of therapeutics that will have a profound effect on many diseases," said Marc Cohen, Co-founder and Executive Chairman of C4 Therapeutics. "The use of Degronimids as a strategy for targeting traditionally undruggable proteins and overcoming resistance is extremely promising. By removing the need for ongoing target inhibition from the therapeutic equation, TPD therapeutics represent a new paradigm in drug development. C4 is a company that will develop many drugs over time in proprietary and partnered development programs."

C4 Therapeutics was co-founded by Ken Anderson, M.D., Kraft Family Professor of Medicine, Harvard Medical School, Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber, and a world-renowned expert in protein degradation and multiple myeloma; Nathanael Gray, Ph.D., Professor of Biological Chemistry and Molecular Pharmacology, Harvard Medical School, Principal Investigator at Dana-Farber and an expert in kinase inhibitors and drug discovery; software and biotech entrepreneur Marc Cohen; and James "Jay" E. Bradner, M.D., former Associate Professor of Medicine, Harvard Medical School and former Investigator at Dana-Farber. With Dr. Bradner’s new role at Novartis Institutes for BioMedical Research, he will no longer have involvement with the Company. C4 will be located at Mass Innovation Labs in Kendall Square, Cambridge. Cobro Ventures led the Series A round, with additional investments from Cormorant Asset Management, The Kraft Group, EG Capital Group, and angel investors. Other investors include Roche and Novartis.

"Drug discovery research around the ubiquitin/proteasome system is an exciting and growing field, and the discovery of Degronimids represents the first all-chemical solution to ligand-mediated protein degradation," said Dr. Nathanael Gray. "The Dana-Farber Cancer Institute has a strong track record of fostering the advancement of groundbreaking discoveries in numerous oncology applications. By licensing these technologies to companies such as C4, we are supporting the further development of highly promising therapeutic candidates for the betterment of human health."
In conjunction with the Series A financing, C4 announced the appointment of Jason Fisherman, M.D., as Chief Executive Officer of the Company and Member of the Board of Directors. Dr. Fisherman has an extensive track record of building companies as a venture investor at Synthesis Capital and Advent International, a global private equity firm, where his team led or managed over 35 investments in biotechnology, medical technology and healthcare information services. Prior to joining Advent International, Dr. Fisherman had over ten years of drug research and clinical development experience in biopharmaceutical companies, academia, and at the National Cancer Institute. Dr. Fisherman received a B.A. in Molecular Biophysics and Biochemistry from Yale, an M.D. from the University of Pennsylvania and an M.B.A. from the Wharton School of the University of Pennsylvania.

"We are pleased to have Dr. Fisherman join our growing team and believe that C4 will greatly benefit from his extensive financial, business and clinical development expertise," said Cohen. "Dr. Fisherman has 30 years of professional experience within the healthcare and life science industry and will help build our leading Degronimid pharmacology platform."

About C4 Therapeutics
C4 Therapeutics is developing a new class of targeted protein degradation (TPD) therapeutics for the treatment of a broad range of diseases. Our Degronimid platform incorporates highly selective small molecule binders to target disease-causing proteins and facilitate their rapid destruction and clearance from the cell through the natural ubiquitin/proteasome system (UPS). Because of this distinctive mechanism, Degronimids are capable of hitting many more targets, including those previously thought to be undruggable, while reducing the potential for drug resistance. The broad applicability of Degronimids, and our chemical biology platform designed for accelerated validation, have the potential to make an unprecedented impact across many diseases through multiple industry collaborations as well as proprietary programs.

On January 07, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new data will be highlighted on prostate and renal cancers at the 2016 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, January 7-9, in San Francisco, Calif (Press release, Myriad Genetics, JAN 7, 2016, View Source [SID:1234508685]). These presentations reaffirm the Company’s commitment to developing pioneering molecular diagnostics in the fight against urological cancers.

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"We are committed to continuing our pioneering work in urology," said Dr. Michael Brawer, M.D., senior vice president of Medical Affairs, Myriad Genetic Laboratories. "Urologic cancers claim thousands of lives every year and are a leading cause of disability. Myriad developed Prolaris, the first prostate cancer prognostic test, and is bringing that same level of rigorous scientific innovation to renal cancer prognosis as well. We remain dedicated to developing new biomarker-based diagnostics to combat urologic diseases and improve patient care."

The following key studies will be presented by collaborators during the ASCO (Free ASCO Whitepaper) GU symposium.

Highlighted Presentations

Title: Application of Active Surveillance Threshold to Series of Samples Submitted for Commercial Testing.
Date: Thursday, January 7, 2016: 11:30 a.m.—1:00 p.m. PT.
Location: Poster Session A.
Presenter: Daniel Lin, M.D., University of Washington.

In this study 11,665 men diagnosed with prostate cancer were evaluated to determine which patients would be candidates for active surveillance (AS) based on their combined clinical risk (CCR) score. CCR is a composite of the Prolaris test with clinical features measured by CAPRA (Cancer of the Prostate Risk Assessment). The results showed that 7,325 men (63 percent) qualified for AS based on their CCR score. Of these, a substantial number of patients, 3,306 (45 percent), would not have qualified for AS based on their clinical features alone. Therefore, for patients considering deferred treatment, the Prolaris test provides significant prognostic information at the time of diagnosis beyond traditional pathological measures of risk.

Title: Prognostic Utility of a Multi-Gene Signature (the Cell Cycle Proliferation Score) in Patients with Renal Cell Carcinoma after Radical Nephrectomy.
Date: Saturday, January 9, 2016: 11:30 a.m.—1:00 p.m. PT.
Location: Poster Session C.
Presenter: Todd Morgan, M.D., University of Michigan.

This study assessed the ability of the myPlan Renal Cancer test to predict disease recurrence or disease-specific mortality in 305 patients who had a radical nephrectomy. The results demonstrate that myPlan Renal Cancer is a significant predictor of key long-term oncologic outcomes in patients who have undergone a radical nephrectomy for renal cancer, providing information beyond what is available from clinical parameters alone. When the myPlan score is combined with pathological stage to provide a composite prognostic score (PS), patients with a high PS had a three-fold increased risk of recurrence compared to patients with a low score. These finding suggest that the myPlan Renal Cancer score may be useful in the clinical management of patients with renal cancer.
For more information about these presentations, please visit the ASCO (Free ASCO Whitepaper) GU website at View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about news and updates by using the hashtag #GU16.

About Prolaris

Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.

About Myriad myPlan Renal Cancer

Myriad myPlan Renal Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with renal cell carcinoma. For more information visit: View Source Jan. 07, 2016 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new data will be highlighted on prostate and renal cancers at the 2016 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, January 7-9, in San Francisco, Calif. These presentations reaffirm the Company’s commitment to developing pioneering molecular diagnostics in the fight against urological cancers.

"We are committed to continuing our pioneering work in urology," said Dr. Michael Brawer, M.D., senior vice president of Medical Affairs, Myriad Genetic Laboratories. "Urologic cancers claim thousands of lives every year and are a leading cause of disability. Myriad developed Prolaris, the first prostate cancer prognostic test, and is bringing that same level of rigorous scientific innovation to renal cancer prognosis as well. We remain dedicated to developing new biomarker-based diagnostics to combat urologic diseases and improve patient care."

The following key studies will be presented by collaborators during the ASCO (Free ASCO Whitepaper) GU symposium.

Highlighted Presentations

Title: Application of Active Surveillance Threshold to Series of Samples Submitted for Commercial Testing.
Date: Thursday, January 7, 2016: 11:30 a.m.—1:00 p.m. PT.
Location: Poster Session A.
Presenter: Daniel Lin, M.D., University of Washington.

In this study 11,665 men diagnosed with prostate cancer were evaluated to determine which patients would be candidates for active surveillance (AS) based on their combined clinical risk (CCR) score. CCR is a composite of the Prolaris test with clinical features measured by CAPRA (Cancer of the Prostate Risk Assessment). The results showed that 7,325 men (63 percent) qualified for AS based on their CCR score. Of these, a substantial number of patients, 3,306 (45 percent), would not have qualified for AS based on their clinical features alone. Therefore, for patients considering deferred treatment, the Prolaris test provides significant prognostic information at the time of diagnosis beyond traditional pathological measures of risk.

Title: Prognostic Utility of a Multi-Gene Signature (the Cell Cycle Proliferation Score) in Patients with Renal Cell Carcinoma after Radical Nephrectomy.
Date: Saturday, January 9, 2016: 11:30 a.m.—1:00 p.m. PT.
Location: Poster Session C.
Presenter: Todd Morgan, M.D., University of Michigan.

This study assessed the ability of the myPlan Renal Cancer test to predict disease recurrence or disease-specific mortality in 305 patients who had a radical nephrectomy. The results demonstrate that myPlan Renal Cancer is a significant predictor of key long-term oncologic outcomes in patients who have undergone a radical nephrectomy for renal cancer, providing information beyond what is available from clinical parameters alone. When the myPlan score is combined with pathological stage to provide a composite prognostic score (PS), patients with a high PS had a three-fold increased risk of recurrence compared to patients with a low score. These finding suggest that the myPlan Renal Cancer score may be useful in the clinical management of patients with renal cancer.
For more information about these presentations, please visit the ASCO (Free ASCO Whitepaper) GU website at View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about news and updates by using the hashtag #GU16.

About Prolaris

Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.

About Myriad myPlan Renal Cancer

Myriad myPlan Renal Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with renal cell carcinoma. For more information visit: View Source Jan. 07, 2016 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new data will be highlighted on prostate and renal cancers at the 2016 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, January 7-9, in San Francisco, Calif. These presentations reaffirm the Company’s commitment to developing pioneering molecular diagnostics in the fight against urological cancers.

"We are committed to continuing our pioneering work in urology," said Dr. Michael Brawer, M.D., senior vice president of Medical Affairs, Myriad Genetic Laboratories. "Urologic cancers claim thousands of lives every year and are a leading cause of disability. Myriad developed Prolaris, the first prostate cancer prognostic test, and is bringing that same level of rigorous scientific innovation to renal cancer prognosis as well. We remain dedicated to developing new biomarker-based diagnostics to combat urologic diseases and improve patient care."

The following key studies will be presented by collaborators during the ASCO (Free ASCO Whitepaper) GU symposium.

Highlighted Presentations

Title: Application of Active Surveillance Threshold to Series of Samples Submitted for Commercial Testing.
Date: Thursday, January 7, 2016: 11:30 a.m.—1:00 p.m. PT.
Location: Poster Session A.
Presenter: Daniel Lin, M.D., University of Washington.

In this study 11,665 men diagnosed with prostate cancer were evaluated to determine which patients would be candidates for active surveillance (AS) based on their combined clinical risk (CCR) score. CCR is a composite of the Prolaris test with clinical features measured by CAPRA (Cancer of the Prostate Risk Assessment). The results showed that 7,325 men (63 percent) qualified for AS based on their CCR score. Of these, a substantial number of patients, 3,306 (45 percent), would not have qualified for AS based on their clinical features alone. Therefore, for patients considering deferred treatment, the Prolaris test provides significant prognostic information at the time of diagnosis beyond traditional pathological measures of risk.

Title: Prognostic Utility of a Multi-Gene Signature (the Cell Cycle Proliferation Score) in Patients with Renal Cell Carcinoma after Radical Nephrectomy.
Date: Saturday, January 9, 2016: 11:30 a.m.—1:00 p.m. PT.
Location: Poster Session C.
Presenter: Todd Morgan, M.D., University of Michigan.

This study assessed the ability of the myPlan Renal Cancer test to predict disease recurrence or disease-specific mortality in 305 patients who had a radical nephrectomy. The results demonstrate that myPlan Renal Cancer is a significant predictor of key long-term oncologic outcomes in patients who have undergone a radical nephrectomy for renal cancer, providing information beyond what is available from clinical parameters alone. When the myPlan score is combined with pathological stage to provide a composite prognostic score (PS), patients with a high PS had a three-fold increased risk of recurrence compared to patients with a low score. These finding suggest that the myPlan Renal Cancer score may be useful in the clinical management of patients with renal cancer.
For more information about these presentations, please visit the ASCO (Free ASCO Whitepaper) GU website at View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about news and updates by using the hashtag #GU16.

About Prolaris

Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.

About Myriad myPlan Renal Cancer

Myriad myPlan Renal Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with renal cell carcinoma. For more information visit: View Source

On Jan 7, 2016 Medivation, Inc. (NASDAQ: MDVN) and NanoString Technologies, Inc., (NASDAQ: NSTG) reported they have entered into a collaboration, together with Astellas Pharma Inc., to pursue the translation of a novel gene expression signature algorithm from Medivation into a companion diagnostic assay using NanoString’s nCounter Dx Analysis System (Press release, NanoString Technologies, JAN 7, 2016, View Source [SID:1234508686]). Under the terms of the collaboration agreement, NanoString will be responsible for developing and validating the diagnostic test and, if the parties thereafter determine to proceed, NanoString would also be responsible for seeking regulatory approval for and commercializing the diagnostic test. NanoString is eligible to receive up to $22 million for technology access, near-term milestones and development funding, in addition to other potential undisclosed downstream payments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the Collaboration Agreement, NanoString will modify its PAM50-based Prosigna Breast Cancer Assay for potential use as a companion diagnostic test for enzalutamide for triple negative breast cancer. The modified test will be based upon data from a Phase 2 trial conducted by Medivation and Astellas that evaluated enzalutamide in patients with triple negative breast cancer.

"We are excited about the partnership with NanoString given their expertise in diagnostic development and that the Prosigna assay has regulatory clearance in the U.S. and European Union," said Amy Peterson, M.D., vice president, clinical development at Medivation. "Triple negative breast cancer has no recognized target and standard therapy is therefore cytotoxic chemotherapy. This diagnostic has the potential to identify patients with triple negative breast cancer appropriate for treatment with enzalutamide. We look forward to generating additional clinical data that validates this potential in a severely underserved patient population."

"We’re excited to work with Medivation and Astellas to translate their discoveries and Phase 2 findings into a potential label expansion for enzalutamide with a companion diagnostic," said Brad Gray, president and chief executive officer of NanoString Technologies. "We’re also pleased to have the opportunity to leverage our PAM50-based Prosigna breast cancer franchise, potentially expanding its role in informing breast cancer treatment decisions and enhancing the description of the intrinsic biology of breast cancer to aid in therapeutic treatment decisions. Furthermore, we believe this collaboration will provide additional validation of our nCounter Dx Analysis System as the platform-of-choice for development of multiplexed companion diagnostic assays."

XTANDI (enzalutamide) capsules is currently approved for the treatment of metastatic castration-resistant prostate cancer; it is not approved for use in women and is contraindicated in women who may become pregnant. Enzalutamide is not approved for women with advanced triple negative breast cancer. See Important Safety Information below.

About the Prosigna Breast Cancer Prognostic Gene Signature Assay
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

In the United States, the Prosigna Assay has 510K clearance and is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes. For more information, please visit www.prosigna.com.

On January 07, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that it has begun enrollment in its pivotal Phase 3 clinical trial evaluating 1404, a small molecule being developed as an imaging agent for prostate cancer (Press release, Progenics Pharmaceuticals, JAN 7, 2016, View Source [SID:1234508687]). 1404 targets prostate specific membrane antigen (PSMA), which is abundantly expressed on prostate cancer cells.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This Phase 3 clinical trial is expected to enroll approximately 450 patients with newly diagnosed low-grade prostate cancer who are candidates for active surveillance, but nonetheless are planning to undergo radical prostatectomy. This multi-center, open-label trial will evaluate the sensitivity and specificity of 1404 in correctly identifying whether or not patients have clinically significant prostate cancer (generally, Gleason score >3+4). In this trial, patients will be imaged prior to their scheduled radical prostatectomy. The truth standard in establishing the sensitivity and specificity of 1404 will be the histopathologist’s grading of the prostate tissue removed in the prostatectomy, which will be compared to the 1404 image assessments. An interim analysis of the study will be performed after approximately one-third of the subjects have been enrolled to assess futility and evaluate the need for a sample size re-estimation.

"An imaging agent like 1404, which may discriminate clinically significant prostate cancer from indolent disease, would provide a useful tool for disease management and treatment, as well as further supporting the use of active surveillance," said William J. Ellis M.D., Professor, Department of Urology, University of Washington School of Medicine and Lead Investigator for the Phase 3 Study. "The goal of active surveillance is to monitor low-grade disease and avoid the risks and complications associated with unnecessary surgical or therapeutic treatments; however, biopsies and other measures currently used to monitor disease progression have their own limitations and risks, curtailing the broader use of active surveillance."

"Commencing this Phase 3 study represents a significant step forward in the clinical development of 1404 and our efforts to bring forward a portfolio of PSMA-targeted imaging agents to help detect and monitor prostate cancer," stated Mark Baker, CEO of Progenics. "We look forward to the timely completion of this trial as we advance 1404 for the detection of clinically significant disease in prostate cancer patients who are candidates for active surveillance."

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with Technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.