Business Wire

BioTime Announces $1.9 Million Grant for Continued Development of OpRegen® for Dry-AMD

Jaa

BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, has been awarded a new grant for 2018 of up to 6.9 million Israeli New Shekels (approximately $1.9 million) from the Israel Innovation Authority (the “IIA”). The grant provides funding for the continued development of OpRegen®, and to date the IIA has provided annual grants totaling over $13 million.

OpRegen® is currently in a Phase I/IIa clinical study, which in March 2018 received authorization from the Data Safety Monitoring Board (DSMB) to move forward with enrollment of cohort 4. The DSMB approval was based on the safety observed throughout the first three cohorts. Safety will remain the primary focus of cohort 4. The fourth cohort will include better vision patients than the previous three cohorts. These better vision patients will likely be in earlier stages of the disease and allow for a wide range of preliminary functional assessment measurements. These earlier stage patients will likely be the target patient population for this therapy and BioTime expects to share initial data from cohort 4 in the coming months.

“The IIA’s continued support is encouraging and shows their commitment and confidence in our ability to continue the development of OpRegen, our lead cell replacement program,” said Adi Mohanty, co-Chief Executive Officer of BioTime.

About OpRegen ®

OpRegen®, which is being studied for the treatment of the dry form of AMD, consists of a suspension of retinal pigment epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also “xeno-free,” meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® will be administered in a single procedure. OpRegen® was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen® is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.

About BioTime, Inc.

BioTime is a clinical-stage biotechnology company focused on degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is producing new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases or injuries. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem® cell and drug delivery matrix technology. HyStem® was designed, in part, to provide for the transfer, retention and/or engraftment of cellular replacement therapies. BioTime’s lead cell delivery clinical program is Renevia®, which consists of HyStem® combined with the patient's own adipose (fat) progenitor cells. Renevia® met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. BioTime has submitted Renevia® for CE Mark approval in the EU. There were no device related serious adverse events reported to date. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy, which is in a Phase I/IIa multicenter clinical trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no unexpected serious adverse events reported to date. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and a private company, AgeX Therapeutics, Inc.

BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on TwitterLinkedInFacebookYouTube, and Google+.

To receive ongoing BioTime corporate communications, please click on the following link to join the Company’s email alert list: http://news.biotime.com.

Forward-Looking Statements

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to product technology, clinical development, regulatory approval timelines, the success of potential cosmetic applications and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty as to the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of BioTime’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Contact information

BioTime
David Nakasone, 510-871-4188
dnakasone@biotimeinc.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Smiths Detection Technology Chosen for Standard 3 Upgrade at Helsinki Airport18.7.2018 12:05Tiedote

Smiths Detection has been selected by Finnish airport operator, Finavia Corporation, to support the transition to Standard 3 at Helsinki Airport with approved hold baggage screening systems. Included in the contract are eight high-speed, HI-SCAN 10080 XCT scanners, which combine high resolution X-ray technology, computed tomography (CT) and advanced detection algorithms to increase both security and operational efficiency significantly. Security, speed and efficiency are critical to the extensive development programme underway at the airport, which will allow the airport to serve 30 million passengers annually and increase baggage handling capacity by 50%. “Any financial investment in upgrading security equipment has to be balanced against operational improvement, particularly when part of a major expansion. Airports need assurance that efficiencies will be gained and systems can be further updated as necessary to detect evolving explosive threats and handle ever higher volumes,” comme

Norsk Titanium Continues to Grow in the State of New York18.7.2018 10:00Tiedote

Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, announced another major milestone in qualified production. Norsk’s Plattsburgh Development and Qualification Center (PDQC) site was officially added to the Spirit AeroSystems Approved Suppliers List (ASL) in anticipation of the start of qualified production later this year. Partnered with the recent announcements of PDQC being added to the Boeing’s Qualified Producer’s List (QPL) list and its certification under AS9100D, this new qualification is key to furthering the availability of Norsk’s disruptive technology in the aerospace market. Spirit AeroSystems is the world’s largest independent aerostructures manufacturer. “These significant achievements have been made possible by the foresight and commitment made to Norsk by the State of New York and Empire State Development. We are extremely proud of our PDQC quality and operations teams and appreciat

EUSA Pharma Announces Acquisition of Global Rights to SYLVANT® (siltuximab) from Janssen Sciences Ireland UC for $115 Million18.7.2018 09:00Tiedote

EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, announced today that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT® (siltuximab) for $115 million in cash. The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions. SYLVANT® is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life threatening and debilitating orphan condition. Idiopathic MCD is an inflammatory lymphoproliferative disorder, which causes the abnormal overgrowth of immune cells and shares many sym

The Best User Interface in Mobile and Web Tracking Just got Better18.7.2018 09:00Tiedote

ThriveTracker, a leading web and mobile tracker for media buyers and performance marketers, today announced the general availability of its latest release featuring an all-new user interface (UI). Inspired by feedback from customers and partners, ThriveTracker designed the new UI to accelerate user adoption, improve usability and increase productivity. ThriveTracker focused on the user experience for all users regardless of device, (Desktop, Mobile, etc.), making it more intuitive and accessible. Improved navigation provides simplified access to frequently used functions in the platform, increases customer awareness of more advanced functionality and delivers fast access to detailed content when necessary. Cleaner, simpler, modern UI Clear, consistent navigation focuses your attention on where you are and what you can do Improved layout delivers common functions intuitively Simplified views provide faster access to relevant content Mobile Friendly Mobile responsive based on device New

JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 22:40Tiedote

NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will

Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 17:00Tiedote

Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme