Next generation modeling sees into the future for ALS patients: Origent Data Sciences accurately predicts function and survival of patients using Diaphragm Pacing System






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CLEVELAND, Aug. 7, 2015 /PRNewswire/ — Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today that the abstract Analysis of Function and Survival in ALS Patients along with Diaphragm Pacing using Virtual Controls by Origent Data Sciences, was accepted for presentation at the 26th Worldwide Symposium ALS/MND this year in Orlando.

Origent Data Sciences, winner of the ALS Prediction Prize4Life Challenge for its health problem progression model in specific patients, has actually deployed their model to Diaphragm Pacing patients.  Data collected from the lead-in controlled prospective clinical study in 106 ALS patients at eight centers showed a considerable overall survival benefit for Diaphragm Pacing patients compared to their predicted outcomes. Origent used 4,633 records from the PRO-ACT database, along with internal and external validation for the survival model. Their findings support the hypothesis that DPS improves survival.

Synapse Biomedical began working along with Origent Data Sciences adhering to their well-received presentation at the 2014 MND Symposium in Belgium.  “Our interest in working along with Origent has actually been to create a responder model for ALS that can easily recommendations inform clinical decision making,” said Anthony Ignagni, President and Chief Executive Officer. “The patient-doctor interaction is quite essential in assisting specific ALS patients decide on their road of therapies. If we can easily recommendations identify those patients that benefit from Diaphragm Pacing—and we have actually constantly maintained that it is not for everyone—after that patients and the field of ALS clinical research will certainly benefit.” 

The controlled methodology Origent used has actually resulted in a robust predictive model for survival in ALS clinical studies.  “Using virtual Manage arm techniques might recommendations us steer clear of incorrect conclusions as a result of possibility effects in trials along with small sample sizes,” said Michael Fritz, VP of Clinical and Regulatory Affairs. “Incorporating these techniques in trial design might offer much better tools for patient recruitment, study monitoring, and validation of results.”

(Honest truth sheets, patient testimonial, product video and images: www.synapsebiomedical.com/news/media)

The NeuRx DPS® is available now for ALS (http://www.synapsebiomedical.com/als/neurx-als.shtml) at U.S. and Worldwide sites or much more short article can easily be obtained by contacting Synapse Biomedical, Inc.

About NeuRx DPS® Technology
NeuRx Diaphragm Pacing System® (NeuRx DPS®) is a four-channel, battery-powered neurostimulator along with implanted electrodes. The device provides electrical stimulation to the muscle and nerves of the diaphragm.

The NeuRx DPS® received CE Marking (CE Registration #518356) on November 20, 2007 and is approved for treating patients along with diaphragm dysfunction in the European Union.

The NeuRx DPS® received FDA approval for ventilator dependency from spinal cord injury on June 17, 2008. In Spinal Cord Injury (SCI), the NeuRx DPS® provides ventilator support in patients along with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can easily result in abnormal or absent respiration in patient populations of high-Degree spinal cord injury and various other injuries or diseases affecting the neuromuscular respiratory pathways.

The NeuRx DPS® received FDA approval for treating chronic hypoventilation from ALS on September 28, 2011. The NeuRx DPS® has actually demonstrated that it can easily recommendations individuals along with ALS live longer and sleep much better compared to the latest standard of care, alone.

For much more on current indications for use, visit www.synapsebiomedical.com/products/patientInfo.shtml

About Synapse Biomedical
Founded in 2002, Synapse Biomedical’s mission is to commercialize our life transforming neurostimulation platform used to treat individuals along with respiratory insufficiency. Synapse is based in Oberlin, Ohio, approximately 30 miles west of Cleveland.

About Origent Data Sciences
Founded in 2012, Origent scientists are experts in the development and application of models made to predict the health problem dynamics of specific patients.  Origent’s mission is to use predictive health problem models to control and reduce drug and device development risks through improved foresight. Origent is based in the Washington, DC metropolitan area.  For much more information, visit: http://www.origent.com/

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SOURCE Synapse Biomedical Inc.

RELATED LINKS
http://www.synapsebiomedical.com

Injection that destroys fat cells may offer option to surgery for double chin, plastic surgeons say

UT Southwestern Medical Focus plastic surgeons have actually a non-surgical approach to treating “double chins” − the moderate-to-severe fat below the chin using an FDA-approved drug that as soon as injected in to tissue destroys fat cells.

The drug, called deoxycholic acid or Kybella, physically destroys the cell membrane as soon as injected in to tissue as a means to eliminate just what is frequently referred to as a double chin. After successful clinical trials, Kybella was recently approved by the Meals and Drug Administration to use as a non-surgical option.

“Kybella is identical to a deoxycholic acid, which is naturally created by the physique to absorb fat. Kybella takes advantage of that fat-destroying activity to tips eliminate the fat below the chin,” explained Dr. Jeffrey Kenkel, Professor and Interim Chairman of Plastic Surgery, that has actually begun performing the procedure in Dallas. “This provides a brand-new option to think of for those that are not prepared for a surgical fix, yet are looking for an answer as to exactly how to overcome fat beneath the chin.”

According to a consumer survey by the American Society for Dermatologic Surgery, 68 percent of respondents were concerned concerning excess fat under the chin and neck. Fifty-two percent of the a lot more compared to 8,300 respondents to the 2014 ASDS Consumer Survey on Cosmetic Dermatologic Procedures indicated they were considering a cosmetic skin procedure to improve their appearance.

The procedure, available on an outpatient basis, entails a handful of injections in to the fat. As numerous as 20 to 30 injections can easily be gained in a single treatment, along with most patients being treated somewhere between two and four times to achieve the desired outcome. Treatments are done no much less compared to one month apart, according to the FDA guidelines. The number of treatments depends on the quantity of fat and others factors determined throughout a consultation. The consultation additionally will certainly tips identify whether a lot more traditional choices such as liposuction or surgery would certainly be a lot more effective. The brand-new drug is aimed at those along with moderate to severe fat beneath the chin, Dr. Kenkel said.

“We will certainly most likely see a different patient type seeking treatment along with Kybella. Those averse to surgery, including a lot more men, will certainly most likely be interested in this brand-new non-surgical treatment for the “double chin,” said Dr. Bardia Amirlak, Assistant Professor of Plastic Surgery.

In addition to Dr. Kenkel and Dr. Amirlak, UT Southwestern physicians trained to give the injections will certainly include Dr. Rod Rohrich, Professor of Plastic Surgery, Cell Biology, and Orthopaedic Surgery; Dr. Nicholas Haddock, Assistant Professor of Plastic Surgery and Orthopaedic Surgery; Dr. Jennifer Kargel, Assistant Professor of Plastic Surgery; Dr. Ron Hoxworth, Associate Professor of Plastic Surgery; and Dr. Jonathan Cheng, Associate Professor of Plastic Surgery and Biomedical Engineering.

Kybella is not intended for others chin related troubles such as sagging skin or “turkey neck,” which could be addressed through others treatments.

The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials that enrolled 1,022 adult participants along with moderate or severe submental fat, according to the FDA. Participants were randomly assigned to receive Kybella or a placebo for up to 6 treatments, and the results showed that reductions in submental fat were observed a lot more regularly in participants that received Kybella.

“The drug destroys cell membranes, so it’s crucial to have actually an experienced, board-certified physician for your procedure so the drug is properly injected in to only the fat cells in a safe and effective manner. The drug can easily destroy others types of cells, so opting for the right doctor to perform the procedure is essential,” said Dr. Kenkel, that has actually been involved along with producing the educational training for physicians about the country.

Kybella is not approved for and ought to not be used outside the submental (chin) area, Dr. Kenkel noted. The most common adverse effects of Kybella include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area. a lot more serious adverse effects can easily include nerve injury in the jaw that can easily create an uneven smile or facial muscle weakness, as well as trouble swallowing.

Once excess fat is removed, patients might still should think of removing excess skin. A neck lift is the traditional surgical treatment for removing skin as well as fat beneath the chin, a procedure known as a lower rhytidectomy or neck lift. The procedure can easily remove excess fat, skin relaxation in the lower face that creates jowls, and excess fatty deposits under the chin, as well as secure loose neck skin and fix muscle banding in the neck.

Intec Pharma Ltd. Announces Closing of U.S. Initial Public Offering






JERUSALEM, August 7, 2015 /PRNewswire/ —

Intec Pharma Ltd. (the “Company”) (NASDAQ: NTEC), a clinical stage biopharmaceutical Business focused on creating drugs based on its proprietary Accordion Pill platform technology, today announced the closing of its previously announced very first public offering in the United States of 5,025,000 of its ordinary shares at a rate to the public of $6.00 per ordinary share, prior to underwriting discounts and commissions.  All the ordinary shares are being offered by the Company.  In addition, the Business has actually granted the underwriters a 45-day option to purchase up to one more 753,750 ordinary shares at the public offering price.  At closing, the Business received gross proceeds from the offering of roughly $30.15 million prior to deducting underwriting discounts and commissions and various other offering expenses.  The Business plans to usage the net proceeds from the offering to fund its Phase III clinical trial for its current product candidate, Accordion Pill Carbidopa/Levodopa, and its continued development, and for functioning capital, capital expenditures and various other general corporate purposes, including a Phase I clinical trial that the Business expects to initiate in the second half of 2015 for one of its early stage pipeline products.

The Company’s ordinary shares began trading on The NASDAQ Capital Market on August 4, 2015 under the symbol “NTEC”.  

Maxim Group LLC and Roth Capital Partners acted as joint book-operating managers for the offering.

Investors could likewise obtain these documents at no cost by visiting the SEC’s website at http://www.sec.gov .

This press release shall not constitute an supply to sell or a solicitation of an supply to buy nor shall there be any type of sale of these securities in any type of state or jurisdiction in which such offer, solicitation or sale would certainly be unlawful prior to the registration or qualification under the securities laws of any type of such state or jurisdiction.

About Intec Pharma Ltd. 

Intec Pharma Ltd. is a clinical stage biopharmaceutical Business focused on creating drugs based on its proprietary Accordion Pill platform technology.  The Company’s Accordion Pill is an oral drug delivery system that is made to boost the efficacy and safety of existing drugs and drugs in improvement by utilizing an efficient gastric retention and individual release mechanism.  The Company’s product pipeline currently involves two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CDLD, is being created for the indication of treatment of Parkinson’s illness symptoms in advanced Parkinson’s illness patients, and Accordion Pill Zaleplon, or AP-ZP, is being created for the indication of treatment of insomnia, including sleep induction and the improvement of sleep maintenance.

Forward Looking Statements 

This press release contains forward-looking statements Concerning the Company’s expectations, beliefs and intentions.  Forward-looking statements can easily be identified by the usage of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or various other comparable words or by the naked truth that these statements do not relate strictly to historical matters.  These forward-looking statements involve certain risks and uncertainties, including, among others, risks impacting the ability of the Business to finish any type of public offering of its securities due to general market conditions or various other factors and risks that could trigger the Company’s outcomes to differ materially from those expected by Business management.  any type of forward-looking statement in this press release speaks only as of the date of this press release.  The Business undertakes no obligation to publicly update or review any type of forward-looking statement, whether as a result of Brand-new information, future developments or otherwise, except as could be needed by any type of applicable securities laws.

Contact:
Zeev Weiss
Chief Executive Officer
(+972)(2)586-4657
Zeev@intecpharma.com

SOURCE Intec Pharma Ltd.

Global Biologics Market, Industry and R&D: Forecasts 2015-2025 Challenges and Opportunities from Rising Drug Demand and Biosimilar Competition






LONDON, August 7, 2015 /PRNewswire/ —

Biological Therapies Locate Revenue Prospects Now, Benefiting Your Authority
Do you want to assess how higher biological drug sales can easily go? Visiongain‘s Brand-new analysis gives you those revenue forecasts to 202five at overall globe market, therapeutic class and national level. For biologics you Locate data, opportunities, R&D and sales potentials.

Our updated report gives you multilevel revenue predictions for biotechnological drugs from 2015, helping you remain ahead. You additionally investigate trends, results, technologies and expected products, benefiting your reputation for technological and commercial insight.

With our study you additionally assess the influence of biosimilars and others emerging treatments on that lucrative, expanding pharma industry and market.

Read on, then, to explore the biologics market from 2015, additionally seeing predicted revenue.

Forecasts and others analysis prove to you where the most effective sales opportunities exist
Our Brand-new report shows revenue forecasting to 2025, business results, sales growth rates and market shares. There you explore quantitative and qualitative analyses, assessing sales potentials and R&D. You gain 57 tables and 33 charts, Along with original research and analysis.

That means you assess clinical, technological and commercial trends, results and potentials such as these issues:
• Why will certainly the biologics market achieve revenue growth from 201five to 2025, and just what sales are feasible from existing drugs and R&D?
• As quickly as will certainly that industry achieve global revenues over $300bn?
• just what treatment classes provide the most promise for developers, producers and sellers?
• That are the best-placed companies in the biopharma industry?
• Where are the crucial and promising regions for selling those treatments?
• How will certainly biological drug producers serve regulators, doctors, patients and payers?

Opportunities in biologics to benefit drug developers, producers and marketers
In 2014 seven of the top ten best-selling drugs were biologics. Several opportunities continue to be for products based on proteins and related biopharma technologies. Our study lets you Locate just what segments are most most likely to prosper, from 201five to 2025, through forecasted sales.

To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com

Why struggle to locate data and others information, losing time and missing out? Instead guidance your research, analyses, plans, proposals and presentations now. Along with visiongain‘s Brand-new investigation see how you can easily save time and benefit your reputation for commercial insight.

Although no single study covers everything, the following sections prove to how our Brand-new investigation benefits your work.

Predictions for that globe market and submarkets see just what sales growth is possible
Along Along with revenue prediction for the overall globe market for biologics, our study shows forecasts from 201five to 202five for 13 specific submarkets:
• Protein therapeutics, Along with sub-forecasting for insulin, others recombinant hormones, plasma and recombinant coagulating factors, interferons, enzyme replacement and others agents
• Monoclonal antibodies (mAbs)
• Fusion proteins
• Regenerative medicine, Along with sub-forecasting for stem cell treatment, tissue engineering and gene therapy
• Vaccines.

Our report gives sales potentials of those biopharmaceuticals. See there how you can easily benefit your plans, decisions, presentations and proposals, additionally helping your influence.

That Brand-new investigation additionally discusses just what stimulates and restrains sales of biologics. You explore that industry, seeing just what products can easily achieve the most success. Discover, from 2015, how pharmaceutical companies can easily gain from biologics.

Our study additionally divides its overall globe forecast in to geographical segments.

National markets for therapeutic proteins where will certainly highest sales and growth occur?
Our study predicts rising demand for biological drugs in made and creating countries. Locate just what sales results and expansion are feasible from 2015.

The analyses prove to you specific revenue forecasts to 202five for 11 national markets:
• • • Brazil, Russia, India and China (BRIC countries).

In our study you Locate outlooks for boosting treatment coverage and expanding revenues. You assess the biologic industry’s future – needs, developments, demands and opportunities.

Our job explores complications affecting biopharma companies, influencing their results.

Forces affecting the biological drugs industry just what shapes its present and future?
The Brand-new report discusses pressures, opportunities and others events affecting the biologics industry and market from 2015, including these influences:
• Achievements of leading drugs, including Rituxan, Humira, Remicade, Simponi, Stelara, Tysabri, Lantus, Avastin, Lucentis, Herceptin and Erbitux
• Research and development, esp. potentials of recombinant DNA technology and emerging processes to benefit patients
• requires and opportunities for creating biologics, including rising prevalence of cancers, autoimmune and neurodegenerative disorders
• Data exclusivity and patent challenges for biopharmaceuticals
• Brand-new products, including Tresiba, Toujeo and Abasaglar
• Next-generation biologics and biobetters – explore competition, technological races and battles, including progress in drug delivery systems.

Our study additionally discusses others aspects of biologics, including these forces:
• Anti-cancer agents, erythropoietins, protease polymerase inhibitors, G-CSF and human growth hormones – investigate prospects for therapeutic classes
• Treatments for haemophilia, diabetes, anaemia, bleeding disorders, wet AMD, multiple sclerosis, arthritis and others chronic diseases – assess developments
• Pricing, reimbursement, clinical efficacy and others challenges – explore regulators’ and others healthcare payers’ demands for biologics, including biosimilars
• Interchangeable biological products versus biosimilars – locate how the FDA differs from the EMA
• Collaborations, partnerships and networks shaping biopharma.

With our Brand-new analysis you assess that industry’s strengths, weaknesses, opportunities and threats. See just what is happening. That means you explore just what restricts and stimulates companies developing, manufacturing, marketing and selling biological medicines.

Companies and 2019 market value just what overall revenue potential?
From 2015, biological product launches hold fantastic potential for investments, demand and sales. Our study predicts the globe market for those drugs will certainly reach $270bn in 2019, Along with sturdy revenue expansion from 201five to 2025. See how higher revenues can easily go.

With our study you assess just what biotechnologies, products and companies hold most potential. Our analyses cover these organisations:
• AbbVie
• Roche
• Amgen
• Johnson & Johnson
• Novo Nordisk
• Bristol-Myers Squibb
• Pfizer
• Merck & Co.

To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com

Our study additionally discusses these companies, among others:
• Novartis
• Sanofi
• GSK
• Eli Lilly
• AstraZeneca
• Teva Pharmaceutical Industries
• Bayer
• Biogen.

From 201five there will certainly arise Several opportunities. Our job shows you commercial possibilities for biological drugs, helping you remain ahead in knowledge and succeed.

Ways Global Biologics Market, Industry and R&D: Forecasts 2015-202five helps
In these 5 main ways, our Brand-new study benefits your research, analyses, decisions, proposals and presentations:
• Revenues to 202five for biologics at overall globe level – Locate outlooks for development, production, marketing and sales
• 13 submarkets revenues to 2025 – investigate that industry’s segments at globe level, finding the most lucrative and fast-rising product groups
• Forecasts to 202five for 11 national markets in the Americas, • Prospects for established competitors and rising companies – explore product portfolios, results, strategies, R&D and outlooks for success
• Analysis of just what encourages and restrains biologic producers – investigate challenges, strengths and competition, helping you remain ahead and succeed.

That survey, by our in-residence UK-based analysts, gives knowledge to benefit your work. Our study shows article you locate nowhere else.

Independent analysis to benefit your authority on pharma biotechnology
Our report provides independent analysis. It gives competitive intelligence found only in our study, helping you assess commercial prospects.

With that investigation you are much less most likely to fall behind in article or skip opportunity. Locate there how to benefit your searches, analyses, plans and decisions, additionally saving time and helping your influence. You assess, from 2015, potentials of biologics.

So explore the future of biopharmaceuticals. In our Brand-new study you locate biologic data, trends, opportunities and sales predictions. remain ahead by getting that report here now.

To request an exec summary of this report please email Sara Peerun at sara.peerun@visiongainglobal.com or call Tel: +44(0)20-7336-6100

Or click on https://www.visiongain.com/Report/Global-Biologics-Market-Industry-and-R-D-Forecasts-2015-2025

Organisations Mentioned in the Report 

3SBio

AbbVie

Acceleron Pharma

Accord Healthcare

Aché

Actavis

Advanced Biohealing

Advanced Tissue Sciences

Advantagene

Alder Biopharmaceuticals

Alexion Pharmaceuticals

Allergan

Alteogen

Amgen

ANVISA (The Agência Nacional de Vigilância Sanitária)

Apotex

Aryogen

Astellas Pharma

AstraZeneca

Athera Pharmaceuticals

Avita Medical

Baxter

Bayer

BaYi Bran hospital

Benda Pharmaceutical

Bioceuticals

Biocon

Biogen

Bioheart

Biolab

Bionovis

BioPartners

Biosidus

Biotest

Bioton

BioXpress Therapeutics

Blackstone Medical

Boehringer Ingelheim

Brazilian Ministry of Health

Bristol Myers Squibb

Cambridge Antibody Technology

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular Drugs Advisory Committee

Celgen Biopharmaceutical

Celgene Corporation

Celltrion

CEL-SCI

Centers of Medicare and Medicaid Services

Centocor

Centocor Ortho Biotech

Children’s Oncology Group

Chinese Centre for Drug Evaluation

CHMP (Committee for Medicinal Products for Human Use)

Chugai

ClinImmune Labs

Coherus Biosciences

CP Guojian Pharmaceutical

Cristália

CSL Behring

CT Arzneimittel

Cystic Fibrosis Foundation

Cystic Fibrosis Foundation Therapeutics

Dong-A Pharmaceuticals Co.

Dr. Reddy’s Laboratories

Drug Controller General of India

Drug Regulatory Authority of Pakistan

Duke University School of Medicine

Elan Corporation

Eli Lilly

EMA (European Medicines Agency)

EMS

Epirus

Eurofarma

FDA (US Meals and Drug Administration)

FibroGen

Finox Biotech

Fuji Pharma

Gan & Lee

Genentech

Gennova

GenSci

Genzyme

German Federal Joint Committee

Gilead Sciences

GKV-Spitzenverband

GlaxoSmithKline

Hanwha Chemical

Health Canada

Hexal

Histogenics

Hospira

Hualida Biotech

Human Stem Cells Institute

Hypermarcas

Immunex Corporation

Immunogen

Indian Central Drugs average Control Organisation

Indian Department of Biotechnology

Intas

Intellectual Property Appellate Board

International Diabetes Federation

Ipsen

Janssen

JCR Pharmaceuticals

Johnson & Johnson

Kissei Pharmaceutical

Kyowa Hakko Kirin

LG Life Sciences

Libbs

LifeSouth Community Blood Centers

Lonza

Marcus Foundation

MEDICE Arzneimittel Pütter

MedImmune

Medipost

Merck & Co.

Merck KGaA

Merz Pharma

Mesoblast

MFDS (South Korean Ministry of Meals and Drug Safety)

MHLW (Japanese Ministry of Health, Labour and Welfare)

MHRA (UK Medicines and Healthcare Regulatory Agency)

Minapharm

Mochida Pharmaceutical

MRC (British Medical Research Council)

Musculoskeletal Transplant Foundation

Mylan

National Cancer Institute

NeoStem

Neuralstem

NICE (National Institute for Care Excellence)

Nichi-Iko

Novartis

Novo Nordisk

NuVasive

NYBC (Brand-new York Blood Center)

Oanda.com

Organogenesis

Orthofix

Orygen

Osiris

Pfizer

Pharmapark

Pharmicell

Pharmstandard

Probiomed

Proteon Therapeutics

Ranbaxy

Ratiopharm

Regeneron

Regenerys

Reliance Life Sciences

Rentschler Biotechnologie.

Roche

RUSH University Medical Center

Sandoz

Sanofi

Schering-Plough

SciGen

Seattle Genetics

SFDA (China State Meals and Drug Administration)

Shanghai CP

Shanghai Fosun

Shanghai Sunway Biotech

Shinogi

Shire

Smith and Nephew

Sotex PharmFirm

Spark Therapeutics

SSN Cardinal Glennon Children’s Medical Center

St. Louis Cord Blood Bank.

STADA Arzneimittel

Stanford University

Stratatech Corporation

Swiss Re

Teva Pharmaceutical Industries

The European Team for Blood and Marrow Transplantation

The National Hemophilia Foundation

Tigenix

Tonghua Dongbao

Toronto University

UCB

UCLA (University of California, Los Angeles)

UCSF (University of California, San Francisco)

União Química

UniQure

United States Congress

United Therapeutics

University of Colorado

University of Colorado Cord Blood Bank

University of Tokyo

US Focus for Disease Prevention and Control

US Patent and Trademark Office

USV Biologics

Virchow Biotech

Vital Therapies

Walter and Eliza Hall Institute

WHO (globe Health Organization)

Wockhardt

World Bank

Wyeth-Ayerst Laboratories

Yonsei University

Zuventus

Zydus Biovation

Zydus Cadila

SOURCE Visiongain

Valor Biotherapeutics to Begin Phase 1 Clinical Study of Novel Lymphoma Therapy






WHITE PLAINS, N.Y. and BRYAN, Texas, Aug. 6, 2015 /PRNewswire-USNewswire/ — Valor Biotherapeutics, LLC, (Valor) and The Leukemia & Lymphoma Society (LLS) today announced that the U.S. Meals and Drug Administration (FDA) has actually approved an investigational Brand-new drug (IND) application for Valor’s lead product candidate, IGN002. The approved IND is a crucial step in allowing Valor—a joint venture between ImmunGene and Caliber Biotherapeutics—to start a phase 1 clinical study of IGN002 in patients along with non-Hodgkin lymphoma (NHL).

Through its Therapy Acceleration Routine (TAP), a strategic initiative to partner along with biotechnology companies and speed the development of Brand-new therapies, LLS previously committed about $6 million to co-fund the pre-clinical development, manufacturing, and a Phase 1 clinical study of IGN002. Valor, ImmunGene, and LLS staff have actually collaborated over the past two years to finish the pre-clinical development and manufacturing of IGN002 for the IND filing.

“Valor is excited to announce this milestone in the development of IGN002 and we anticipate starting the Phase 1 clinical study later this year,” said Sanjay D. Khare, Ph.D., a founding board member of Valor Biotherapeutics and president and CEO of ImmunGene. “We are grateful for the technical and financial support of The Leukemia & Lymphoma Society and expect continuing our partnership as we job with each other to get there the IGN002 program.”

IGN002 is a Brand-new class of biotherapeutics genetically engineered by fusing an antibody along with interferon, a healthy protein that plays a vital role in regulating the immune system. Together, they form a potent agent that is created to be safer and much less toxic while maximizing its targeted anti-tumor effects. IGN002 has actually the potential to boost treatment outcomes for indolent non-Hodgkin lymphoma (NHL) patients, for whom there are currently few efficient therapies. NHL is a diverse group of blood cancers that impact the lymphatic system, portion of the body’s immune system. In the U.S., indolent subtypes of NHL comprise regarding 30 percent of the about 585,000 individuals living along with or in remission from NHL. IGN002 was produced under the support of a research grant by LLS.

“Non-Hodgkin lymphoma, whether indolent or aggressive, continues to be a illness requiring much more effective, much less toxic therapies and this project shows fantastic promise in assisting to comply with that vital unmet need,” said LLS President and Chief Executive Officer Louis J. DeGennaro, Ph.D.  “We are pleased to see an additional example of The Leukemia & Lymphoma Society’s commitment to bridging the gap between academic discovery and drug development. LLS helped accelerate the antibody-fusion technology underlying the IGN002 Routine by providing early funding of an academic grant.”

About IGN002
IGN002, a fusion molecule of anti-CD20 antibody and interferon alpha, two clinically validated anti-cancer drugs, is created to deliver therapeutically efficient doses of interferon alpha to CD20-expressing lymphoma cells to exert direct suppression of tumor cell growth and engage multiple anti-tumor immunologic effector mechanisms, leading to substantially improved efficacy while avoiding the systemic toxicity seen along with free interferon.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world’s largest voluntary healthiness agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and boost the quality of life of patients and their families. LLS funds lifesaving blood cancer research about the world, provides free short article and support services, and is the voice for every one of blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in

About Valor Biotherapeutics, LLC
Valor Biotherapeutics, a joint venture between ImmunGene, Inc. and Caliber Biotherapeutics, is focused on the clinical development and commercialization of the next generation of monoclonal antibody-based therapeutics to handle cancer. For much more information, please visit: www.valorbio.com.

About ImmunGene Inc.
ImmunGene is a privately held biotechnology company focused on the development of proprietary antibody-cytokine fusion technology and monoclonal antibody-based therapies to handle cancer, autoimmune disorders, and various other diseases. ImmunGene has actually several programs at various stages of development. ImmunGene is funded by federal government grants, including NIH-SBIR and by private investors including several biotechnology executives. much more short article can easily be found at: www.immungene.com.

About Caliber Biotherapeutics, LLC
Caliber Biotherapeutics is a biotechnology company focused on creating and commercializing novel therapeutic proteins and vaccines that boost outcomes for patients along with cancer and various other diseases. Caliber operates the world’s largest N. benthamiana expression-based healthy protein manufacturing facility in College Station, Texas. For much more information, please visit www.caliberbio.com.

The Leukemia & Lymphoma Society
Contact: Andrea Greif
Tel: (914) 821-8958
Cell: (914) 772-3027
andrea.greif@lls.org

Valor Biotherapeutics/ImmunGene
Contact: Leah Grant
Tel: (206) 660-4003
leahgrant@comcast.net

 

SOURCE The Leukemia & Lymphoma Society

RELATED LINKS
http://www.LLS.org