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OncoSec to Host Webcast and Panel Discussion on New Melanoma Clinical Data

SAN DIEGO, April 13, 2016 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will host a webcast to provide an overview and panel discussion regarding new clinical data that will be featured as an oral presentation at the upcoming American Association of Cancer Research (AACR) Annual Meeting. The webcast will be held on Wednesday, April 20, 2016 at 11:00 AM ET/8:00 AM PT.

The webcast will include a round table discussion to enable key opinion leaders in the fields of melanoma and immuno-oncology to contribute their respective insights on data from the AACR abstract entitled: “Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma” (Abstract #CT134). Webcast participants will include:

  • Alain Algazi, MD, Skin Cancer Specialist, Melanoma Center, University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
  • Adil Daud, MD, Clinical Professor, Department of Medicine (Hematology/Oncology), UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
  • Robert Andtbacka, MD, CM, Associate Professor, Division of Surgical Oncology, Department of Surgery, University of Utah School of Medicine; Surgeon and Investigator, Intermountain Healthcare and Huntsman Cancer Institute
  • Sharron Gargosky, PhD, Head of Clinical Development and Operations, OncoSec*
  • Moderator: Robert Pierce, MD, Chief Scientific Officer, OncoSec

To join via webcast, please use the following link: http://edge.media-server.com/m/p/np97wpek. To listen to the conference call, please dial (877) 731-1960 and enter conference ID number: 84899794. An archived version of the presentation will be available for 90 days on the “Investors” section of OncoSec’s website: ir.oncosec.com/events.

About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies for the treatment of cancer. The Company’s investigational technology, ImmunoPulse™, is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as interleukin-12 (IL-12). In Phase I and II clinical trials, OncoSec’s lead program, ImmunoPulse™ IL-12, demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. ImmunoPulse™ IL-12 is currently in clinical development for several indications, including metastatic melanoma and triple-negative breast cancer. In addition to ImmunoPulse™ IL-12, the Company is also seeking to identify and develop new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “will,” “can,” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec’s filings with the Securities and Exchange Commission.

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

*Dr. Gargosky is serving as a consultant.

Contact
Mary Marolla
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com

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SOURCE OncoSec Medical Incorporated

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PR Newswire

Sequenom Strengthens Executive Team with New Vice President of Sales

Medical Diagnostics Industry Veteran Will Help Drive Growth of Sequenom Laboratories Tests in New and Existing Channels

SAN DIEGO, April 12, 2016 /PRNewswire/ — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, is pleased to announce that Glenn Magnuson has joined the Company as Vice President of Sales, reporting to Rob Lozuk, Senior Vice President, Commercial Operations.  Mr. Magnuson has more than 25 years of experience in implementing effective sales processes, strategically managing accounts and realizing the revenue potential of medical diagnostic devices.

“I’m delighted to welcome Glenn to Sequenom’s executive team,” said Dirk van den Boom, Ph.D., President and CEO of Sequenom.  “The three new tests we launched in 2015 and our entry in the average-risk pregnancy market provide Sequenom Laboratories with outstanding potential to expand its market presence, both for noninvasive prenatal tests as well as in carrier screening.  Glenn’s proven record of motivating sales teams and facilitating long term business relationships in medical diagnostics and women’s health is exactly what Sequenom Laboratories needs to expand its contribution to women’s healthcare.”

“With the broadest array of laboratory-developed tests in the industry, strong backing from maternal fetal medicine specialists, and its knowledgeable and professional sales team, Sequenom Laboratories is well-positioned to bring the benefits of noninvasive prenatal testing to as many patients as possible, including women with average-risk pregnancies,” said Mr. Magnuson.  “My experience in medical diagnostics — specifically including my background in women’s health – is a great fit with Sequenom Laboratories’ growth potential in this market.”

Glenn Magnuson has 25 years of medical diagnostic sales experience, including immunology sales at Abbott Diagnostics; women’s diagnostic tests at Cytyc / Hologic; and clinical chemistry, hematology, pathology, and molecular and point of care technologies at ThermoFisher Scientific.  Most recently, Mr. Magnuson was Vice President of Sales for T2 Biosystems, a leading provider of an FDA-approved Candida direct whole blood sepsis test.  He holds a Bachelor of Science degree in Business Administration from Bryant University in Rhode Island.

About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a pioneering genetic testing company dedicated to women’s health through the development of innovative products and services.  The Company serves patients and physicians by providing early patient management information.  For more information, visit www.sequenom.com.

About Sequenom Laboratories
Sequenom Laboratories, a CAP-accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory tests, with a focus principally on prenatal care.  Branded under the names HerediT®, HerediT® UNIVERSAL, MaterniT® GENOME, MaterniT21® PLUS, NextView®, SensiGene® and VisibiliT™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, and maternal fetal medicine specialists.  Sequenom Laboratories is changing the landscape in genetic diagnostics using proprietary cutting edge technologies. Visit www.laboratories.sequenom.com and follow @SequenomLabs.

SEQUENOM®, HerediT®, MaterniT®, NextView®, SensiGene®, VisibiliT and Sequenom Laboratories are trademarks of Sequenom, Inc.  All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the development of innovative products and services, the ability to expand the Company’s market presence for non-invasive prenatal tests and carrier screening and the ability to bring the benefits of noninvasive prenatal testing to as many patients as possible.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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SOURCE Sequenom, Inc.

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Oncternal Therapeutics Awarded Exclusive Worldwide License to ROR1 Antibody and Related Programs from UC San Diego

Pioneering Research at UC San Diego Provides Foundation for New Cancer Focused Start-Up

SAN DIEGO, April 12, 2016 /PRNewswire/ — Oncternal Therapeutics, Inc., a new oncology-focused biotechnology company, today announced that it has received an exclusive worldwide license to develop and commercialize antibodies and antibody-related binding agents recognizing Receptor-tyrosine kinase-like orphan receptor 1 (ROR1) from University of California San Diego.  The licensing agreement also encompasses rights for all therapeutic indications to cirmtuzumab, an anti-ROR1 monoclonal antibody that is currently in a clinical trial for patients with chronic lymphocytic leukemia (CLL), as well as rights to develop antibody-drug conjugates (ADCs), genetically modified effector immune cells, such as chimeric antigen receptor T-cells (CAR-T), and bispecific antibodies. 

The formation of Oncternal Therapeutics is based upon the pioneering research of UC San Diego scientist and clinician, Thomas J. Kipps, M.D. Ph.D., Evelyn and Edwin Tasch Chair in Cancer Research, Distinguished Professor UC San Diego, and Deputy Director, Research Operations, Moores Cancer Center.  As one of the most wide-ranging licensing transactions executed by UC San Diego’s Office of Innovation and Commercialization, the agreement includes upfront and milestone payments, research funding for the Kipps laboratory, clinical support, product royalties, and an equity position in Oncternal.  Specific financial terms of the agreement were not disclosed.

“We are delighted to complete this agreement with Oncternal Therapeutics, as it furthers our goal of developing effective therapies for patients with any one of a number of types of cancer, including leukemia and lymphoma, as well as solid tumors, such as ovarian or breast cancer,” said Dr. Kipps. “We are very pleased to see our discovery, research and early clinical development program trigger the formation of a new biotechnology company in San Diego led by an experienced leadership team.”

“The scientific work done by Dr. Kipps and his colleagues has been extraordinary and holds great promise to generate a new wave of first-in-class, targeted cancer therapies,” said David F. Hale, Chairman of Oncternal Therapeutics.  “We are excited to build a world-class company focused on the development of these promising ROR1 programs, which feature novel science and a strong intellectual property portfolio that we plan to enhance in the future.  We look forward to rapidly advancing cirmtuzumab into additional clinical trials and bringing forward novel therapeutics for the treatment of patients with these devastating diseases.”

The anti-ROR1 monoclonal antibody, cirmtuzumab, was developed at UC San Diego by Dr. Kipps, with funding from the US National Institutes of Health, the California Institute for Regenerative Medicine (CIRM), and the Blood Cancer Research Fund.  Cirmtuzumab is currently being tested in a phase 1 clinical trial for patients with relapsed/refractory CLL.  Studies have shown that ROR1 is expressed by a number of hematologic malignancies as well as by a number of solid tumors.

“Creating a treatment that will help patients is not just a matter of good scientific work, it’s also a matter of good business planning and leadership. This agreement brings those two elements together,” says C. Randal Mills, President and CEO of CIRM.  “We are hopeful this alliance will help accelerate the progress of Dr. Kipps research, and we congratulate him and his team at UC San Diego.”

Oncternal will also continue development of several preclinical development programs initiated by UC San Diego, including potential ROR1-directed ADCs, with early evidence of promising anti-tumor efficacy and specificity, and several potential CAR-T vectors, which can be introduced into a cancer patient’s T-cells, enabling the cells to recognize and kill tumor cells that express ROR1.  Oncternal Therapeutics intends to continue the development of the CAR-T program in collaboration with the Moores Cancer Center. 

“One of our missions as a public university is to translate our research into public benefit,” said Paul Roben, Associate Vice Chancellor for Innovation at UC San Diego. “This successful collaboration exemplifies that commitment to social responsibility.”

Cirmtuzumab
Cirmtuzumab is a humanized IgG1 monoclonal antibody that was designed and developed to bind with high affinity to a biologically important epitope on the extracellular domain of ROR1. Binding of cirmtuzumab to ROR1 on tumor cells inhibits Wnt5a signalling, a pathway that is important for tumor-cell proliferation, migration, and survival. Blockade of this Wnt5a signaling leads to tumor cell death by apoptosis.

About ROR1
Receptor-tyrosine kinase-like orphan receptor 1 – also known as ROR1 — is a type 1 transmembrane protein that is expressed on the plasma membrane with an extracellular domain that is essential for ligand binding and signal transduction.  High-level expression of ROR1 has been found in many cancers.  The highest and most consistent expression of the ROR1 protein is in mantle cell lymphoma (MCL) where virtually all patient samples express ROR1, and CLL, where 95 percent express ROR1 on the cell surface.  ROR1 is also expressed at high frequency in many solid tumors, including lung and ovarian cancers, as well as triple-negative breast cancer.

About Oncternal Therapeutics
Oncternal Therapeutics has been formed around the groundbreaking research at UC San Diego of Dr. Thomas Kipps on the ROR1 signaling system, and the development of antibodies and related binding agents to treat ROR1-expressing cancers.  The Oncternal leadership team has extensive experience in the formation and successful development of biotechnology companies and innovative pharmaceutical products.  The founders and initial board members include David F. Hale, Cam Garner, Scott Glenn, and James B. Breitmeyer, who have been involved in founding and/or development of a number of life sciences companies in San Diego.  Hale and Garner were members of the senior management team of Hybritech with its subsequent sale to Eli Lilly and Company.  One or more of the founders have had key roles with Gensia, Dura, CancerVax, Santarus, SkinMedica, Quidel, Dexcom, Neurelis, Cadence, Evoke Pharma, Zogenix, and a number of other life sciences companies in San Diego.  For more information, visit www.oncternal.com.

Investor Contact:

James Breitmeyer
Oncternal Therapeutics
858-434-1113
jbreitmeyer@oncternal.com

Media Contact:

Ami Knoefler
Spark BioComm
650-739-9952
ami@sparkbiocomm.com

 

SOURCE Oncternal Therapeutics, Inc.

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Oska Pulse(TM), First-Of-Its-Kind, Wearable Pain Relief Device, Debuts For Individuals Suffering From Chronic Pain

100M Americans Who Suffer From Chronic Pain Now Have A Non-Invasive, Drug-Free Solution With No Known Side Effects; Individuals Can Take Control Of Their Pain Management With Oska Pulse

SAN DIEGO, April 12, 2016 /PRNewswire/ — San Diego-based Oska Wellness, a technology company committed to developing consumer health and wellness products, today introduced the revolutionary, made in the U.S.A., Oska Pulse™. This innovative wearable pain relief device is designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for more than 100 million Americans who suffer from chronic pain. Using proprietary eTec™ Pulse Technology, Oska Pulse is a small, portable device that safely optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, a longtime therapy used by medical practitioners to help individuals live a more active, pain-free and drug-free lifestyle. 

Surveyed in 2012 by the Substance Abuse and Mental Health Services Administration, over 2 million Americans suffer from substance abuse due to prescription opioid pain relievers. According to the Center for Disease Control and Prevention, more than 40 Americans die every day from prescription opioid overdoses.  Unfortunately, even over-the-counter (OTC) pain relievers have risks. OTC acetaminophen drug abuse is one of the most common causes of liver failure in the United States. According to a 2014 study published in the Expert Review of Clinical Pharmacology, OTC drugs with acetaminophen send an average of 80,000 people annually to emergency rooms due to abuse.

As an alternative to pain medication, Oska Pulse offers pain sufferers a non-invasive, drug-free technology that has no known side effects. Now, people can take control of their pain and enjoy a more active lifestyle without the dangers of drugs, and without a physician’s prescription. To learn more, please visit www.oskawellness.com.

Dr. Joseph Shurman, Anesthesiologist and Chairman of Pain Management at Scripps Memorial Hospital in La Jolla, California, endorses the Oska Pulse, applauding its capabilities. “Pain management is about easing the suffering and improving well-being and quality of life and function. As a physician, I am constantly trying non-invasive, drug free pain management solutions. I like the fact that the Oska Pulse is easy to use and has no known side effects. I am recommending the Oska Pulse to some of my patients. I believe it can offer general relief and well being to many pain sufferers.” Dr. Shurman is currently on the Oska Wellness Scientific Advisory Board.

Oska Pulse aids in providing intended relief of minor aches and pains, reducing stiffness and promoting increased mobility by promoting the body’s natural recovery processes. People of all ages who have pain due to injury, surgery or trauma can benefit from this innovation. It is a smart, safe, easy-to-use, wearable health technology product designed for today’s pain sufferers.  With a suggested retail price of $399, Oska Pulse is a high-performance alternative to clinical products, which utilize similar technologies that can cost thousands of dollars.

“I suffer from chronic hip pain,” says Leslie Cross, Chairman of Oska Wellness, former Chairman and CEO of DJO Global, a manufacturer and worldwide leading distributor of electrotherapy products for pain therapy and rehabilitation. “I joined the team after using the product for a few days, because my pain was gone without taking any medication. Now, I wear the device several times a day, which allows me to stay active, take long walks, and play golf with my friends and much more. This product can help a lot of people like me, and for that reason I am excited to be involved with the launch of the Oska Pulse to the public.”

Oska Pulse, which comes with a specially designed compression wrap, can be worn comfortably at any time, under or over garments, and near problem areas. In fact, the device can be worn while going about your normal daily activities like walking through a store or working at a desk. When the product is “in session”, a soft, pulsing blue light will appear around the perimeter of the device for 30 minutes, and individuals will have no sensation, which makes it completely unobtrusive.  Some individuals will find immediate benefits when using the Oska Pulse, while others may need several sessions over a few days before they begin to feel relief.  Most individuals will find better results with repeated and extended use.

“Oska Pulse is providing relief for many early users of the product by helping to reduce back, shoulder, knee, ankle, and foot pain. The feedback from these early adopters has been amazing, and we are thrilled to see Oska helping so many people,” said Greg Houlgate, Oska Wellness CEO.

The benefits of PEMF (Pulsed Electromagnetic Field) therapy have been documented in multiple clinical studies. Some of these studies can be found on the Company’s website. It is recommended that individuals who are pregnant or nursing and/or who have a heart pacemaker or defibrillator as well as those being treated for cancer should consult their physician before using Oska Pulse.

For more information on Oska Pulse, or to purchase the product directly, visit www.oskawellness.com.

About Oska Wellness
Oska Wellness, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle.  We believe that people suffering from pain deserve relief without the side effects of medication. The revolutionary Oska Pulse utilizes our patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, which is very similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself. The science and technology behind the Oska Pulse was engineered and developed by a team of respected scientists and researchers with over 25 years of experience in engineering health and wellness technologies to treat pain. The product is proudly manufactured and assembled in the U.S.A. The U.S. Food and Drug Administration has not evaluated the Oska Pulse. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition.

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SOURCE Oska Wellness

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PR Newswire

Forge Therapeutics to Participate in FBR Healthcare Series to Highlight New Approaches to Fighting Infections

SAN DIEGO, April 12, 2016 /PRNewswire/ — Forge Therapeutics, Inc., a biotechnology company discovering innovative therapeutics using a breakthrough drug discovery platform targeting metalloproteins, announced today that Forge will participate in the FBR Healthcare Series event being held at the JW Marriott Essex House in New York City on April 20, 2016. The theme of the event is “New Prescriptions: Innovation of Diseases and Infections” and Zachary A. Zimmerman, Ph.D., CEO of Forge, will participate in a panel discussion entitled “Showcase of Novel Technologies in Fighting Infections. 

To learn more about the conference, please visit www.fbr.com.

About Forge Therapeutics, Inc.
Forge Therapeutics, Inc. (“Forge”) is a biotechnology start-up that leverages its novel chemistry platform to develop small molecule inhibitors to target metalloproteins. Metalloproteins are proteins that require metal ions for their biological function and make up over 1/3 of the proteins in the human body. Forge uses a proprietary approach comprised of molecular modeling for rational drug design along with fundamental knowledge and expertise in bioinorganic chemistry to target metalloproteins. The name Forge Therapeutics comes from two definitions for forge: to manipulate (inhibit) a metal object (metalloprotein) and to move forward steadily with a purpose (the Forge team).  Forge Therapeutics, Inc., maintains its headquarters in San Diego, California. To learn more please visit www.ForgeTherapeutics.com.   

Contact:
Info@ForgeTherapeutics.com

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SOURCE Forge Therapeutics, Inc.

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Digital Health Summer Summit and BIO International Convention to Convene Under One Roof to Ignite the Digital Health Tipping Point

Both conferences to be held in San Francisco June 6 – 9, 2016 bringing leaders in biotech, pharma and technology together

SAN FRANCISCO, April 11, 2016 /PRNewswire/ — Living in Digital Times and Biotechnology Innovation Organization (BIO) announce today that the annual Digital Health Summer Summit (DHSS) and the BIO International Convention will co-locate to give the biotech, pharma and digital health industries a content-rich four days and the ultimate networking experience.  Both conferences will be held at the Moscone Center in San Francisco the week of June 6th, with dynamic digital health content offered on June 6 – 9.

Tweet this: Biotech, pharma & tech converge to ignite digital health tipping point June 6-8 #DHSS16 #BIO2016 http://bit.ly/1TGDJnT

“Teaming up with BIO will give Digital Health Summer Summit attendees unprecedented access to decision makers at biotech and pharmaceutical companies who attend the BIO International Convention,” said Jill Gilbert of Living in Digital Times, producer of the DHSS.  “Our attendees will also have the opportunity to utilize BIO’s proprietary online business development tool, One-on-One Partnering™, to identify potential partners and schedule meetings with them in advance.”   

The annual BIO International Convention attracts more than 15,000 attendees, with 40 percent at the managing director level or higher.  An impressive 29,000-plus business meetings were arranged through BIO’s One-on-One Partnering™ system and held at the convention over the course of just three days in 2015.

“Two years ago, we recognized the need to add a digital health track to our convention offerings, as more and more of our members are interested in learning how digital health will benefit their businesses,” said Sarah Arth, Managing Director, Industry & Event Education, BIO.  “This year, we’ve partnered with Living in Digital Times, the experts who have been tracking this space closely and delivering provocative conference content year after year, to give our attendees an even deeper understanding of the issues at stake and the opportunity to network with digital health influencers.”

BIO invited DHSS as a marquis producer to put a spotlight on the emerging future of digital health: the latest in AI, virtual reality, deep cognitive learning, robotics, personalized medicine, digital diagnostics and therapeutics, workplace health wearables, internet of health things and more.

This year’s DHSS will focus on “Igniting the Tipping Point” in digital health with two full immersive days of keynotes and panel discussions on Monday, June 6th and Tuesday, June 7th.  BIO’s digital health track will follow on Wednesday, June 8th and Thursday, June 9th.

The DHSS conference content will tackle four key areas:

  • Real-world business case studies from established digital health companies with strong footholds in transforming the system
  • Curated tools necessary to grow roots in this industry and elevate one’s business
  • Revelation of the most promising markets and opportunities on which to capitalize
  • Creating partnerships required for every stakeholder’s success

View the full DHSS conference agenda and keep up with the current list of speakers here.

BIO will continue to offer a digital health track, as part of its more than 120 sessions offered at the BIO International Convention for those interested in the digital health sector on Wednesday, June 8th and Thursday, June 9th.  The sessions will focus on the intersection of biotechnology and digital health and how the market is reacting. View the session details here.

Various packages are available for those interested in attending the DHSS, which include different levels of access to the BIO International Convention for a bundled discounted rate.  View complete details and register online today here.

The DHSS and BIO International Convention are open to credentialed members of the media free of charge.  View complete media guidelines and register online here.  Registered media will have full access to both conferences.  One-on-One Partnering is not included, but can be purchased separately.

For updates on DHSS, follow Digital Health on Twitter at @DHSummit, “like” Digital Health Summit on Facebook, connect with us on LinkedIn and follow the hashtag #DHSS16.

For updates on the BIO International Convention and One-on-One partnering, visit convention.bio.org or follow BIO on Twitter at @BIOConvention and @BIO1X1, and follow the hashtag #BIO2016.

About Living in Digital Times:
Founded by veteran technology journalist Robin Raskin, Living in Digital Times brings together the most knowledgeable leaders and the latest innovations impacting both technology and lifestyle.  It helps companies identify and act on emerging trends, create compelling company narratives, and do better business through strong network connections.  Living in Digital Times produces technology conferences, exhibits and events at CES and other locations throughout the year by lifestyle verticals.  Core brands include Digital Health Summit, Digital Money Forum, FitnessTech, Baby Tech, Kids@Play, Family Tech Summit, TransformingEDU, MommyTech TV, Beauty Tech, Wearables and FashionWare runway show, Mobile Apps Showdown, Last Gadget Standing, Robots on the Runway and the KAPi Awards. 

The company also works with various foundations and manages the Appreneur Scholar awards program for budding mobile entrepreneurs, as well as the 10 Under 20: Young Innovators to Watch awards recognizing student STEAM innovations in New York City. 

For more information, visit www.LivinginDigitalTimes.com and keep up with our latest news on Twitter, LinkedIn and Facebook.

About BIO
BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

Media Contacts: 
Linda Krebs
LKPR, Inc. for Digital Health Summer Summit 
LK@LKPublicRelations.com
646-484-4539
646-824-5186 (mobile)

Theresa Brady
Biotechnology Innovation Organization (BIO)
tbrady@bio.org
202-962-9235
202-279-0536 (mobile)

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SOURCE Living in Digital Times

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Profusa Awarded $1.75M NIH Grant to Further Develop Tissue-integrated Biosensors for Continuous Oxygen Monitoring in PAD Patients

SOUTH SAN FRANCISCO, Calif., April 11, 2016 /PRNewswire/ — Profusa, Inc., a leading developer of tissue-integrated biosensors, today announced that the National Institutes of Health has awarded it a $1.75 million grant under the Small Business Innovation Research (SBIR) program. Adminis­tered by the National Heart, Lung, and Blood Institute (NHLBI), the funding will support Fast-tracked Phase I and Phase II studies of the company’s Lumee™ tissue-integrated biosensors for continuous monitoring of oxygen toward improving the clinical outcomes of patients suffering from peripheral artery disease (PAD).

“This NIH award is further validation of the potential of our biosensor technology for having a significant impact in transforming clinical outcomes for patients with PAD,” said Ben Hwang, Ph.D., Profusa’s chairman and chief executive officer. “These studies will be crucial in advanc­ing our technology and products towards regulatory approvals and commercialization.”

The Phase I of the grant will fund safety studies of the Lumee technology, and Phase II will fund a clinical study of the technology at the University of California San Francisco. The grant is the second Fast-track small business grant Profusa has received from the NHLBI for development of its tissue-integrated oxygen biosensors for PAD.

Natalie Wisniewski, Ph.D., a co-principal investigator of the studies and Profusa’s co-founder and chief technology officer, said, “Our goal is to further demonstrate the functionality of Profusa’s novel Lumee oxygen biosensor technology in patients with PAD, and to determine its ability to predict surgical outcomes and to guide additional therapies to avoid amputation.”

Phase I of the program is aimed at verifying the biocompatibility of the biosensors, which to date have been shown to be functional for more than two years within the body. Phase II includes a 50-patient clinical trial to be conducted by co-principal investigator Christopher Owens, M.D., M.Sc., Associate Professor of Surgery, Division of Vascular and Endovascular Surgery at the University of California San Francisco. Dr. Owens also serves as Chief, Section of Vascular Surgery, San Francisco VA Medical Center, and Director of the Vascular Integrated Physiology ad Experimental Therapeutics Laboratory at UCSF.

“Profusa’s oxygen-sensing technology may allow doctors for the first time to know the tissue oxygen levels in the ischemic limb before, during, and after treatment,” explained Dr. Owens. “We’ll be able to more accurately select patients who will need a revascularization procedure to heal their wounds, and we will be able to monitor the change in tissue oxygen during and after the procedure in order to guide our treatment and know when it is complete. The upside for our patients will be less pain and disability, improved function, and fewer amputations.”

Peripheral Artery Disease
PAD affects 202 million people worldwide, 27 million of whom live in Europe and North America, with an annual economic burden of more than $74 billion in the U.S. alone. PAD is caused by plaque buildup in the blood vessels of the legs, resulting in decreased delivery of vital nutrients and oxygen necessary to maintain healthy tissue. As the disease advances, patients can experience significant leg pain with impaired mobility (claudication), and in its most severe form, critical limb ischemia (CLI), gangrene and limb amputation.

Lumee Oxygen Sensing System™
Profusa’s first medical product, the Lumee Oxygen Sensing System, is aimed at being the only long-term monitoring technology that prompts therapeutic action to ensure tissue oxygen levels persist throughout the PAD treatment and healing process. Pending CE Mark, the Lumee sys­tem is slated to be available in Europe in 2016 for use by vascular surgeons and wound-healing specialists.

Profusa, Inc.
Profusa, Inc., based in South San Francisco, Calif., is leading the development of a new generation of tissue-integrated sensors that empowers an individual with the ability to monitor their unique body chemistry in unprecedented ways to transform the management of personal health and disease. Overcoming the body’s response to foreign material for long-term use, its technology promises to be the foundational platform of real-time biochemical detection through the development of tiny bioengineered sensors that become one with the body to detect and continuously transmit actionable, medical-grade data for personal and medical use. See http://www.profusa.com for more information.

Research reported in this press release is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL131366. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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SOURCE Profusa, Inc.

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PR Newswire

Viking Therapeutics Presents Positive Phase 1b Clinical Data on VK2809 in Hypercholesterolemic Subjects

Novel Oral Thyroid Receptor Agonist Triggers Substantial and Clinically Meaningful Reductions in LDL Cholesterol, Triglycerides and Key Atherogenic ProteinsPresentation Receives “Best Poster” Award from ACC Conference

SAN DIEGO, April 11, 2016 /PRNewswire/ — Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today highlighted positive data from a Phase 1b clinical trial of VK2809 in subjects with mild hypercholesterolemia, presented at the 65th Annual Scientific Session & Expo of the American College of Cardiology (ACC).  The results demonstrated substantial and clinically meaningful reductions in subjects’ low-density lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic proteins lipoprotein-a and apolipoprotein B following 14 days of treatment.  VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in this patient population. 

The randomized, double-blind, placebo-controlled Phase 1b study was designed to evaluate the safety, tolerability and pharmacokinetics of VK2809, at a range of doses, in 56 subjects with elevated serum cholesterol (n = 6 per drug-treated cohort).  Following 14 days of VK2809 treatment, subjects demonstrated clinically and statistically significant placebo-adjusted reductions in LDL-C ranging from 15.2% at the 5.0 mg dose (p=0.026) to 41.2% at the 20 mg dose (p<0.0001).  In addition, subjects experienced placebo-adjusted reductions in triglycerides ranging from 34.8% at 5.0 mg dose (p=0.052) to 78.6% at the 40 mg dose (p=0.0001).  Significant reductions in lipoprotein-a and apolipoprotein B were also observed, with declines of 30% or more reported at all doses above 2.5 mg. 

Treatment with VK2809 was also shown to be safe and well-tolerated at all doses studied. No serious adverse events were reported and no treatment- or dose-related trends were observed for abnormal vital signs, electrocardiograms, cardiac rhythm or physical examination assessments.  Consistent with liver-targeted thyroid receptor activation, mild, asymptomatic elevations in liver enzymes and decreased thyroid hormone levels were observed at higher doses.  Metabolically, VK2809 was not eliminated intact through the kidneys, and less than 3% of the administered dose was eliminated through the kidneys as the drug’s active metabolite, VK2809A. 

“We believe these results provide compelling preliminary evidence of VK2809’s efficacy in this important indication.  The observed statistically significant effects in a trial of this size and duration are quite promising and demonstrate the potential therapeutic benefits of thyroid receptor modulation for lipid dysregulation,” said Brian Lian, Ph.D., chief executive officer of Viking.  “These data, combined with VK2809’s novel liver-targeted delivery and mechanism of action, as well as prior in vivo data demonstrating robust reductions in hepatic fat content, provide a strong rationale for applications in settings such as hypercholesterolemia and fatty liver disease.  We believe that receipt of a Best Poster award from a conference of this stature reinforces the potential importance of the results.  We are focused on further establishing the safety and efficacy profile of VK2809 and continue to prepare for our upcoming Phase 2 clinical trial, which we expect to initiate mid-year.”

Viking is currently planning to initiate a Phase 2 clinical trial of VK2809 in patients with hypercholesterolemia and fatty liver disease.  The Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL-C and fatty liver disease. 

About VK2809
VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor entering Phase 2 development for the treatment of patients with hypercholesterolemia and fatty liver disease.  VK2809 belongs to a family of novel prodrugs which are cleaved in vivo to release potent thyromimetics.  Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression of low-density lipoprotein (LDL) receptors and increasing mitochondrial fatty acid oxidation.  These characteristics suggest a highly differentiated therapeutic profile relative to existing oral options for patients with hypercholesterolemia and fatty liver disease, such as nonalcoholic steatohepatitis (NASH).  The potential markets for these indications are significant.  In the U.S., approximately 33% of adults, or 71 million people, have elevated LDL cholesterol.  Additionally, NASH is rapidly becoming a leading cause of cirrhosis and liver failure and affects an estimated 6 to 15 million Americans. 

About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.  The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives.  Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.  The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist entering Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Viking is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.

Forward Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking’s expectations regarding the company’s proposed Phase 2 clinical trial for VK2809, as well as VK2809’s potential to produce therapeutic benefits. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking’s product candidate development activities and clinical trials; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements.

 

SOURCE Viking Therapeutics, Inc.

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