Monthly Archives: March 2015

DUBLIN, Mar. 03, 2015 /PRNewswire/ --Research and Markets

(http://www.researchandmarkets.com/research/rcv4lq/gene_therapy) has announced the addition of the "Gene Therapy Market, 2015 - 2025" report to their offering.

The "Gene Therapy Market, 2015-2025" report provides an extensive study on the marketed and pipeline gene therapies. A lot of research has been carried out in this field for over a decade but there are only five approved therapies (four available in Asian markets; one approved in the EU). There are many promising therapies which are currently being developed worldwide; the approach is likely to result in several commercial success stories in the foreseen future. The report covers various aspects, such as key players, marketed gene therapy products, products in clinical / pre-clinical research, associated ethical issues, likely future developments and upcoming opportunities for a variety of stakeholders.

Several disorders that arise inside the body are a result of either a direct genetic aberration or a dysfunctional/non-functional protein. The attempt to use nucleic acids to correct or delete the genes causing a particular disease is known as gene therapy. Although gene therapy has not contributed significantly to the global pharmaceutical market yet, it is anticipated to grow at a fast pace over the next decade.

Gendicine, developed by SiBiono GeneTech, was the foremost gene therapy that entered market in 2004 in China. Since then four more therapies have received approval in China, Philippines, Russia and the EU. This number for approved / marketed therapies seems weak at present; however, the strong and highly populated pipeline holds tremendous potential. There are 12 gene therapies in late stage of clinical development for the treatment of cancer, ocular and cardiovascular disorders.

There are several concerns that remain to be answered; examples include insertional mutagenesis, treatment of multigene disorders, curbing the risk of immune reactions, eugenics, high cost of therapy and ethical concerns related to making alterations at the genetic level. Despite this, gene therapy does offer a ray of hope for patients who either have no treatment options or show no benefits with drugs that are currently available. Such a benefit far outweighs any disadvantages that may be associated with this upcoming therapeutic field.

Key Topics Covered:

1. Preface

2. Executive Summary

3. Introduction

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Global Gene Therapy Market Report 2015-2025 - Extensive Study on the Marketed and Pipeline Gene Therapies

DUBLIN, Mar. 03, 2015 /PRNewswire/ --Research and Markets

(http://www.researchandmarkets.com/research/gxqhg9/gene_therapy) has announced the addition of Jain PharmaBiotech's new report "Gene Therapy - Technologies, Markets and Companies" to their offering.

Gene therapy technologies are described in detail including viral vectors, nonviral vectors and cell therapy with genetically modified vectors. Gene therapy is an excellent method of drug delivery and various routes of administration as well as targeted gene therapy are described. There is an introduction to technologies for gene suppression as well as molecular diagnostics to detect and monitor gene expression.

Clinical applications of gene therapy are extensive and cover most systems and their disorders. Full chapters are devoted to genetic syndromes, cancer, cardiovascular diseases, neurological disorders and viral infections with emphasis on AIDS. Applications of gene therapy in veterinary medicine, particularly for treating cats and dogs, are included.

Research and development is in progress in both the academic and the industrial sectors. The National Institutes of Health (NIH) of the US is playing an important part. As of 2014, over 2050 clinical trials have been completed, are ongoing or have been approved worldwide.A breakdown of these trials is shown according to the geographical areas and applications.

Since the death of Jesse Gelsinger in the US following a gene therapy treatment, the FDA has further tightened the regulatory control on gene therapy. A further setback was the reports of leukemia following use of retroviral vectors in successful gene therapy for adenosine deaminase deficiency. Several clinical trials were put on hold and many have resumed now. The report also discusses the adverse effects of various vectors, safety regulations and ethical aspects of gene therapy including germline gene therapy.

The markets for gene therapy are difficult to estimate as there is only one approved gene therapy product and it is marketed in China since 2004. Gene therapy markets are estimated for the years 2014-2024. The estimates are based on epidemiology of diseases to be treated with gene therapy, the portion of those who will be eligible for these treatments, competing technologies and the technical developments anticipated in the next decades. In spite of some setbacks, the future for gene therapy is bright.The markets for DNA vaccines are calculated separately as only genetically modified vaccines and those using viral vectors are included in the gene therapy markets

The voluminous literature on gene therapy was reviewed and selected 750 references are appended in the bibliography.The references are constantly updated. The text is supplemented with 75 tables and 15 figures.

Profiles of 181 companies involved in developing gene therapy are presented along with 223 collaborations. There were only 44 companies involved in this area in 1995. In spite of some failures and mergers, the number of companies has increased more than 4-fold within a decade.

Key Topics Covered:

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Gene Therapy Market Report 2014-2024 - Technologies, Markets and Companies

Mason, OH (PRWEB) March 03, 2015

The combinatorial, multi-gene GeneSight test has been found to better predict antidepressant treatment outcomes for patients with depression, and their use of health care resources, than any of the individual genes that comprise the test, according to a peer-reviewed analysis by investigators from the Mayo Clinic and Assurex Health, and published online by The Pharmacogenomics Journal i.

The proprietary technology of the GeneSight Psychotropic test is based on combinatorial pharmacogenomics (CPGx), the study of how variations in multiple genes collaborate to influence an individuals response to medications, and evidence-based medicine and the known clinical pharmacology of various drugs.

This new publication shows that the combinatorial GeneSight test predicts which patients are likely to experience poorer antidepressant outcomes and use more health care services, whereas single gene diagnostics mostly did not, said lead author and Assurex Health Senior Vice President, C. Anthony Altar, Ph.D. The robust evidence from these analyses reinforce the advantage of the combinatorial GeneSight test in helping clinicians guide antidepressant and anti-anxiety treatment decisions. This and other features of GeneSight distinguish our pharmacogenomic products from all others.

The GeneSight Psychotropic test helps inform clinicians treatment selection for commonly prescribed medications including those for depression, post-traumatic stress disorder (PTSD), anxiety, bipolar disorder and schizophrenia. The test is covered by Medicare, the U.S. Department of Veterans Affairs, and a growing number of commercial payers.

Evaluating Drug Metabolism with Genetic Data

The CPGx approach that generates the GeneSight report examines DNA variations of multiple genes since these variations can change the efficacy, metabolism, and adverse effects of many psychiatric drugs. Using a patients unique genetics, the GeneSight Psychotropic test creates a personalized report that places 38 U.S. Food and Drug Administration (FDA)-approved medications for depression and other mental health conditions into three color-coded categories for clinicians to review: Use as Directed in green, Use with Caution in yellow, or Use with Increased Caution and with More Frequent Monitoring in red. The GeneSight report also alerts healthcare providers to the implications of the patients genetic information to a drugs dosage, and FDA-approved package insert information. Most single gene tests have high variability and are less accurate in predicting patient responses to psychotropic medications. The GeneSight approach compensates for these limitations by aggregating predictions by the drug metabolism and response genes to better predict patients responses.

Nearly 90 percent of antidepressant and antipsychotic medications are metabolized by at least two of the liver cytochrome P450 (CYP) enzymes, and many interact with the brain serotonin transporter (SLC6A4) or the serotonin 2A receptor (HTR2A), explained the authors. The GeneSight Psychotropic test accounts for this complexity by measuring and combining the DNA sequence variations within drug response and drug metabolism genes. This analysis looked at the GeneSight test that included the liver metabolism genes CYP2D6, CYP2C19, CYP2C9, and CYP1A2, and the two drug response genes, SLC6A4 and HTR2A.

Since these studies were conducted, Assurex Health has enhanced the GeneSight test to include two more genes, CYP3A4 and CYP2B6, making it the first and only psychiatric pharmacogenomic test to offer CYP3A4 analysis distinct and separate from CYP3A5. The CYP2B6 gene affects medications including bupropion (Wellbutrin), the third most commonly prescribed antidepressant.

GeneSight Outperforms Single Gene Tests in Predicting Patient Outcomes

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GeneSight Multi-Gene Combinatorial Pharmacogenomic (CPGx) Test is More Predictive of Antidepressant Response than ...