Category Archives: Genetics

WASHINGTON--(BUSINESS WIRE)--

Today, the Genetics Policy Institute (GPI) announced the opening of a new, GPI National Affairs Office in Washington, D.C.

Recent years have seen GPIs involvement with policy and regulatory issues impacting the translation of stem cells and other advanced technologies into medicine steadily increase, necessitating the establishment of a new, permanent office location in the nations capital.

This new location will also give GPI the opportunity to begin hosting an array of high-level workshops, seminars, and events aimed at removing roadblocks to innovative bio-medical solutions found within the fields of stem cell research and regenerative medicine.

Said GPIs Executive Director, Bernard Siegel of the need for advocacy driven workshops and related events, While many other countries are establishing funded, national programs or strategies to advance cell therapies and regenerative medicine, the US lags.

He added that time is of the essence as patients are facing the crushing burden of chronic disease and immense human suffering. To fulfill the curative promise in years, rather than decades, Washington must declare regenerative medicine a national priority and immediately establish coordination between federal agencies. We need a consensus strategy that includes all necessary funding.

Being at the intersection of research, medicine, law and patient advocacy, GPI boasts a track record of bringing stakeholders together with the aim of delivering on the promise of stem cells and regenerative medicine.

About the Genetics Policy Institute (GPI): GPI is a 501(c)(3) nonprofit corporation with the mission to promote stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, the online newsletter 360 Weekly, special projects, speaking engagements, educational initiatives, and strategic collaborations.

GPI maintains offices in Palm Beach, Florida; Palo Alto, California and Washington, D.C. For more information, visit http://www.genpol.org.

Please direct all media inquires to GPI Associate Director, Alan Fernandez at Genetics Policy Institute, 701 8th Street NW, Suite 400, Washington, DC, telephone 888-238-1427 or email alan@genpol.org.

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Genetics Policy Institute Opens Washington, D.C. Office

PALM BEACH, Fla. & CAMBRIDGE, United Kingdom--(BUSINESS WIRE)--

The Genetics Policy Institute (GPI) and univerCELLmarket announced a joint initiative to produce the most comprehensive and timely online news aggregation and distribution service, providing actionable intelligence for the stem cell and regenerative medicine communities.

Expanding the current 360 newsletter published online by univerCELLmarket, the newsletter will be now co-published and distributed with GPI. Bernard Siegel, GPIs founder and executive director, joins Dr. Beverley Vaughan as the co-editor of the publication. GPI and univerCELLmarket maintain free subscription links on their respective web sites.

Bernard Siegel said, It is the aim of GPI to provide the highest quality information to all interested in stem cells and regenerative medicine. We are delighted to partner with univerCELLmarket. Their comprehensive news aggregation service enables users to efficiently research its archived news and records. With this partnership, interested stakeholders who are part of both GPIs and univerCELLmarkets extensive databases, honed over the past decade, will have easy access to news they can use to advance our field.

Dr. Cathy Prescott, respected thought-leader in the business of stem cells and regenerative medicine, and co-founder of univerCELLmarket said, As a result of partnering with GPI, 360 is now the most widely circulated news service in the world dedicated to this field. With this partnership, our combined contacts, which span academia, industry, government, law, ethics, medicine and advocacy will receive the news highlights in their in-box every Monday, with links to all the weeks news on univerCELLmarket.com.

Jeanette Walker, co-founder of univerCELLmarket stated, 360 is popular because it is so comprehensive and in a format that makes it quick and easy to scan. We are delighted to welcome Bernard Siegel to our editorial team as he is a recognized architect of the global stem cell community. Bernie founded GPI, the annual World Stem Cell Summit, the peer-reviewed World Stem Cell Report and is an acknowledged leader of the patient advocacy community.

About Genetics Policy Institute (GPI): GPI is a 501c3 nonprofit foundation with the mission to promote and defend stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, special projects, speaking engagements, teaching initiatives and strategic collaborations.

ABOUT univerCELLmarket

Launched in 2010, univerCELLmarket.com is an online, global source of relevant, up-to-date information for everyone interested in the field of stem cells and regenerative medicine. Users can rapidly search 10 directories for a wide range of information including stem cell tools, reagents, banks and therapies as well as manufacturers, professional services, academic centres, networks and societies all searchable by country/State - plus the latest news and upcoming events.

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Genetics Policy Institute and univerCELLmarket to co-publish 360 – the Free Newsletter Covering Stem Cells and ...

PALM BEACH, Fla. & CAMBRIDGE, United Kingdom--(BUSINESS WIRE)--

The Genetics Policy Institute (GPI) and univerCELLmarket announced a joint initiative to produce the most comprehensive and timely online news aggregation and distribution service, providing actionable intelligence for the stem cell and regenerative medicine communities.

Expanding the current 360 newsletter published online by univerCELLmarket, the newsletter will be now co-published and distributed with GPI. Bernard Siegel, GPIs founder and executive director, joins Dr. Beverley Vaughan as the co-editor of the publication. GPI and univerCELLmarket maintain free subscription links on their respective web sites.

Bernard Siegel said, It is the aim of GPI to provide the highest quality information to all interested in stem cells and regenerative medicine. We are delighted to partner with univerCELLmarket. Their comprehensive news aggregation service enables users to efficiently research its archived news and records. With this partnership, interested stakeholders who are part of both GPIs and univerCELLmarkets extensive databases, honed over the past decade, will have easy access to news they can use to advance our field.

Dr. Cathy Prescott, respected thought-leader in the business of stem cells and regenerative medicine, and co-founder of univerCELLmarket said, As a result of partnering with GPI, 360 is now the most widely circulated news service in the world dedicated to this field. With this partnership, our combined contacts, which span academia, industry, government, law, ethics, medicine and advocacy will receive the news highlights in their in-box every Monday, with links to all the weeks news on univerCELLmarket.com.

Jeanette Walker, co-founder of univerCELLmarket stated, 360 is popular because it is so comprehensive and in a format that makes it quick and easy to scan. We are delighted to welcome Bernard Siegel to our editorial team as he is a recognized architect of the global stem cell community. Bernie founded GPI, the annual World Stem Cell Summit, the peer-reviewed World Stem Cell Report and is an acknowledged leader of the patient advocacy community.

About Genetics Policy Institute (GPI): GPI is a 501c3 nonprofit foundation with the mission to promote and defend stem cell research and its application in medicine to develop therapeutics and cures for many otherwise intractable diseases and disorders. GPI pursues this mission through production of its flagship annual World Stem Cell Summit, publication of the World Stem Cell Report, special projects, speaking engagements, teaching initiatives and strategic collaborations.

ABOUT univerCELLmarket

Launched in 2010, univerCELLmarket.com is an online, global source of relevant, up-to-date information for everyone interested in the field of stem cells and regenerative medicine. Users can rapidly search 10 directories for a wide range of information including stem cell tools, reagents, banks and therapies as well as manufacturers, professional services, academic centres, networks and societies all searchable by country/State - plus the latest news and upcoming events.

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Genetics Policy Institute and univerCELLmarket to co-publish 360 – the Free Newsletter Covering Stem Cells and ...

Published:Tuesday, April 16, 2013

Updated:Tuesday, April 16, 2013 22:04

The Alcohol Research Center (ARC) at UConn received a grant that provides five years of funding through 2017 in order to continue research on several studies including one that began in 1989.

Dr. Victor Hesselbrock, the primary investigative researcher, explained over the phone the major benefits the grant will have to the ARC which includes further research on the study of the genetics of alcoholism (COGA). The research for COGA is looking at extensive evidence that genes influence the vulnerability to alcoholism. About 17,000 individuals have participated in the study from five different states across the country. The planning for the study began in 1988 and officially received funding in 1989. COGA also focuses around identifying genes associated with developmental problems caused by alcohol.

We have identified 30 different genes in different organ systems associated with problems of alcohol use (within the study), said Hesselbrock. We also learned about taste sensitivity. There are genes that prefer or like the taste of alcohol. Then there are other genes that dont like the taste of alcohol and it provides a protection factor. The grant is funding four main studies and pilot studies surrounding alcoholism according to Hesselbrock. The four main studies include: COGA, seeing if college students in the real world drink as much as in college, risk factors associated with alcohol and obesity among adolescent girls and using E-Technology to track alcohol use in patients that have alcohol problems. The pilot studies will begin in the early fall and will center around testing varied cells for IPS (Immature Pluripotent stem cells) to generate stem cells and neurons found in the brain and look at the affects of alcohol. Rather than using real brain tissue the ARC can duplicate it in a test tube. Hesselbrock joked that not many people are willing to donate their own brain tissue.

Another pilot study includes examining older people and to see how alcohol affects their balance, gate and cognition done in low doses. The patients are given one or two drinks and researchers will see how they are affected differently compared to younger college students. Hesselbrock explained that much of the studies done at the ARC offers opportunities to develop pharmacological interventions for alcoholism and important implications for prevention and treatments.

Working in the department of psychiatry and addiction is major part. We have identified genes and their vulnerability, said Hesselbrock. We have been able to identify types of individuals with different levels of risks and vulnerabilities for substance abuse. There is a lot of cognitive testing of these individuals. Weve identified styles or deficits that contribute to a persons risk of substance abuse. Hesselbrock says the study is considered to be large and by using large sample numbers of individual has led to finding results for the numerous studies.

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Genetics of alcoholism research

Seattle Genetics Inc. (SGEN) recently presented data on its antibody-drug conjugate (ADC) candidates at the annual meeting of the American Association for Cancer Research (:AACR).

Preclinical data on SGN-CD33A showed significant antitumor activity in acute myeloid leukemia (:AML) models. Seattle Genetics intends to file an investigational new drug (IND) application and start a phase I study in 2013.

Another candidate, SGN-LIV1A, showed encouraging pre-clinical data for breast cancer. Seattle Genetics will file an IND application for SGN-LIV1A as well and start a phase I study in 2013 for breast cancer.

Seattle Genetics sole marketed ADC product is Adcetris. Adcetris is used for the treatment of patients with Hodgkin's lymphoma (HL) after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris is also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen.

Adcetris was approved by the US Food and Drug Administration (:FDA) in Aug 2011, got EU approval in Oct 2012 and marketing authorization in Canada in Feb 2013.

ADCs have been attracting a lot of interest of late with major companies entering into collaborations. Seattle Genetics has collaborations with companies like Roche Holding AG's (RHHBY) Genentech for the development of ADCs.

A few days back, Astellas Pharma, Inc. (ALPMY) announced a deal with Ambrx Inc. for the discovery and development of novel ADCs.

Seattle Genetics carries a Zacks Rank #3 (Hold). Right now Cleveland BioLabs, Inc. (CBLI) looks more attractive with a Zacks Rank #1 (Strong Buy).

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ADC Data from Seattle Genetics

Seattle Genetics Inc. (SGEN) recently received approval from Health Canada for its oncology drug, Adcetris (brentuximab vedotin). Adcetris has been approved under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of patients with Hodgkins lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris was also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen.

For similar indications, Adcetris was approved by the US Food and Drug Administration (FDA) in Aug 2011 and in the EU in Oct 2012.

The NOC/c requires Seattle Genetics to conduct clinical trials to confirm the anticipated clinical benefit of Adcetris. Seattle Genetics is currently enrolling patients for two confirmatory phase III studies evaluating the drug for the front-line treatment of HL and mature T-cell lymphoma (MTCL), including sALCL.

Our Take

We are positive on Seattle Genetics' efforts to penetrate new markets. In Canada, Adcetris is the first in a new class of antibody-drug conjugates (ADCs) to be approved. Adcetris' revenues for the nine months ending Sep 30, 2012 were $102.8 million.

Seattle Genetics carries a Zacks Rank #4 (Sell). Right now Peregrine Pharmaceuticals, Inc. (PPHM), Valeant Pharmaceuticals (VRX) and Targacept, Inc. (TRGT) look more attractive with a Zacks Rank #1 (Strong Buy).

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Canada Approves Seattle Genetics' Adcetris - Analyst Blog

Seattle Genetics Inc. (SGEN) recently received approval from Health Canada for its oncology drug, Adcetris (brentuximab vedotin). Adcetris has been approved under Health Canada's Notice of Compliance with conditions (NOC/c) for the treatment of patients with Hodgkins lymphoma (HL) after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT.

Adcetris was also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen.

For similar indications, Adcetris was approved by the US Food and Drug Administration (:FDA) in Aug 2011 and in the EU in Oct 2012.

The NOC/c requires Seattle Genetics to conduct clinical trials to confirm the anticipated clinical benefit of Adcetris. Seattle Genetics is currently enrolling patients for two confirmatory phase III studies evaluating the drug for the front-line treatment of HL and mature T-cell lymphoma (:MTCL), including sALCL.

Meanwhile, in Jan 2013, a global phase III study (ECHELON-2) was initiated on Adcetris. In this study, Adcetris plus chemotherapy will be evaluated for the front-line treatment of CD30-positive MTCL including patients with sALCL and other types of peripheral T-cell lymphomas.

Our Take

We are positive on Seattle Genetics efforts to penetrate new markets. In Canada, Adcetris is the first in a new class of antibody-drug conjugates (ADCs) to be approved. Adcetris revenues for the nine months ending Sep 30, 2012 were $102.8 million.

Seattle Genetics carries a Zacks Rank #4 (Sell). Right now Peregrine Pharmaceuticals, Inc. (PPHM), Valeant Pharmaceuticals (VRX) and Targacept, Inc. (TRGT) look more attractive with a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on SGEN

Read the Full Research Report on TRGT

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Canada Approves Seattle Genetics' Adcetris

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.

We are focused on making ADCETRIS available globally to all eligible patients with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the recent approval in the European Union, are important milestones to accomplish this goal, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Now that Health Canada has approved ADCETRIS, we are committed to working closely with public and private insurers to secure reimbursement coverage for patients in Canada.

The approval of ADCETRIS in Canada marks a significant milestone for patients with relapsed HL or sALCL who have had few new treatment options in several decades, Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.

Health Canada grants NOC/c, a form of market approval, on the basis of promising evidence of clinical effectiveness, for products intended for the treatment of serious, life-threatening or severely debilitating illnesses that meet a serious unmet medical need or demonstrate a significant improvement in the benefit/risk profile over existing therapies. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the anticipated clinical benefit of ADCETRIS in these patients. Two confirmatory phase III clinical trials evaluating ADCETRIS in the front-line treatment setting of HL and mature T-cell lymphoma (MTCL), including sALCL, are currently underway and enrolling patients.

ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients. ADCETRIS is administered in hospitals through IV infusion over 30 minutes every three weeks and patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately one year).

ADCETRIS is the first in a new class of antibody-drug conjugates (ADCs) to be approved in Canada. Using Seattle Genetics proprietary technology, the ADC consists of a monoclonal antibody directed to an antigen called CD30. The monoclonal antibody is connected to a cell-killing agent by a linker system that is designed to be stable in the bloodstream but to release the cell-killing agent into CD30-expressing cells, resulting in target cell death. The CD30 antigen is known to be expressed on the Reed-Sternberg cells of HL and on sALCL, an aggressive type of T-cell non-Hodgkin lymphoma.

Health Canadas approval of ADCETRIS is the first step in getting patients access to this important therapy, said Sue Robson, Executive Director of Lymphoma Foundation Canada. The Lymphoma Foundation is committed to working with Canada provincial governments to ensure that appropriate patients have access to this new therapy.

About Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma ...

Seattle Genetics, Inc. (SGEN) recently presented interim results from a phase I study which is evaluating ASG-5ME for the treatment of metastatic pancreatic ductal adenocarcinoma (:PDA).

Seattle Genetics is developing ASG-5ME, an antibody-drug conjugate (ADC) which targets the SLC44A4 antigen, for the treatment of solid tumors. The candidate is being developed in collaboration with Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc. (ALPMY).

The trial is being conducted to evaluate the safety and activity along with identifying the maximum tolerated dose (MTD) of ASG-5ME in patients suffering from metastatic PDA. Approximately 35 patients with metastatic PDA and a median age of 63 were administered doses ranging from 0.3 milligrams per kilogram (mg/kg) to 1.5 mg/kg administered weekly for three of every four weeks. Data from the study, apart from providing preliminary evidence for antitumor activity, revealed that the candidate was well tolerated.

We note that Seattle Genetics is also evaluating ASG-5ME in the prostate and gastric cancer indications. Seattle Genetics focuses on the development and commercialization of monoclonal antibody-based therapies for cancer.

We remind investors that Seattle Genetics leading drug, Adcetris, is currently approved in the US for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients, who are not suitable for ASCT and the treatment of sALCL in treatment-experienced patients. Adcetris is approved in the EU as well.

Seattle Genetics carries a Zacks Rank #3 (Hold). Pharma stocks, which currently appear to be more attractive include Valeant Pharmaceuticals (VRX) and Salix Pharmaceuticals (SLXP). Both companies carry a Zacks Rank #1 (Strong Buy).

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Data From SGEN on Cancer Candidate

SALT LAKE CITY, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) announced today that Peter D. Meldrum, President and CEO, is scheduled to present at the 2013 J.P. Morgan Annual Healthcare Conference, at 9:30 a.m. Pacific Time on Monday, January 7, 2013. The conference is being held at the Westin St. Francis in San Francisco, California.

The presentation will be available to interested parties through a live webcast accessible on the investor relations section of Myriad's website at http://www.myriad.com.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com

Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-G

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Myriad Genetics to Present at the 2013 J.P. Morgan Annual Healthcare Conference