Investorideas.com newswire, breaking biotechnology and pharma news

Wednesday, May 3, 2017

Cytomegalovirus ( #CMV) News; VBI Vaccines (Nasdaq: $VBIV) (TSX: $VBV) Reports on its Congenital CMV Phase I Clinical Study

Cytomegalovirus ( #CMV) News; VBI Vaccines (Nasdaq: $VBIV) (TSX: $VBV) Reports on its Congenital CMV Phase I Clinical Study

Congenital  #CMV infection is a leading cause of birth defects, affecting more live births than #Downsyndrome or #fetalalcoholsyndrome




CAMBRIDGE, MA - May 3, 2017 (Investorideas.com Newswire)   Breaking Vaccine News: VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) ("VBI") provides an update on its cytomegalovirus ("CMV") Phase I clinical study, which is assessing the safety and tolerability of VBI's vaccine candidate to prevent congenital CMV infection. Congenital CMV infection is a leading cause of birth defects, affecting more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority.

Upon review of all safety data up to one month after second immunizations in VBI's prophylactic CMV Phase I clinical study, the Data and Safety Monitoring Board ("DSMB") unanimously recommended the continuation of the study without modification. No safety signals have been detected, suggesting VBI's CMV vaccine candidate is safe and well-tolerated.

Additionally, all participants in the study have now successfully received the third and final immunization in the series. Further vaccine immunogenicity and safety follow-up are ongoing.

An interim safety and immunogenicity report, based on blood samples collected from participants one month post-second vaccination, is expected mid-year 2017.

                       
About the Phase I Clinical Study Design
The Phase I study is designed to assess the safety and tolerability of VBI’s CMV vaccine candidate in approximately 125 healthy CMV-negative adults. The study will also determine the vaccine immunogenicity by measuring levels of vaccine-induced CMV neutralizing antibodies, which may prevent CMV infection.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT02826798.

About the Data and Safety Monitoring Board
The DSMB was formed with key opinion leaders, a statistician, and experts in safety in clinical studies of this nature. The board is an arms-length committee that monitors the clinical study to assess safety data at various time points during the clinical study, and to recommend to VBI whether to continue, modify, or stop the study.

About CMV
CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and mental retardation. CMV affects more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement.


About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac™, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI’s eVLP Platform technology enables the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

·        Website Home: https://www.vbivaccines.com/  
·        News and Insights: https://www.vbivaccines.com/wire/
·        Investors: https://www.vbivaccines.com/investors/  


VBI Contact
Perri Maduri, Communications Executive
Phone: (617) 830-3031

VBI Investor Contact
Nell Beattie
Director, Corporate Development and Investor Relations

Cautionary Statement on Forward-looking Information
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “may”, “plan”, “will”, “suggesting”, “expected”, and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: plans for Phase III clinical studies, the provision of additional information about clinical studies, the safety and tolerability of the congenital CMV vaccine candidate, the provision of an interim safety and immunogenicity report, and the potential effects of Sci-B-Vac™.

Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company’s products, including the receipt of necessary regulatory approvals; general economic conditions; competitive conditions; and changes in applicable laws, rules and regulations.

Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company’s products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company’s reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions.

Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Contact each company directly regarding content and press release questions. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp. Disclosure – the following is a paid news release for VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) Learn more about our newswire . pricing and how to publish your news- http://www.investorideas.com/News-Upload/
Additional info regarding BC Residents and global Investors: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.




Tuesday, May 2, 2017

VBI Vaccines @VBIVaccines (Nasdaq: $VBIV) (TSX: $VBV) Provides Update on its Congenital #CMV Phase I Clinical Study

VBI Vaccines @VBIVaccines (Nasdaq: $VBIV) (TSX: $VBV) Provides Update on its Congenital #CMV Phase I Clinical Study

Positive Safety Review and Final Vaccination of All Participants



CAMBRIDGE, MA (May 2, 2017) – (Investorideas.com Newswire) VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) today provided an update on its cytomegalovirus (“CMV”) Phase I clinical study, which is assessing the safety and tolerability of VBI’s vaccine candidate to prevent congenital CMV infection. Congenital CMV infection is a leading cause of birth defects, affecting more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority.

Upon review of all safety data up to one month after second immunizations in VBI’s prophylactic CMV Phase I clinical study, the Data and Safety Monitoring Board (“DSMB”) unanimously recommended the continuation of the study without modification. No safety signals have been detected, suggesting VBI’s CMV vaccine candidate is safe and well-tolerated.

Additionally, all participants in the study have now successfully received the third and final immunization in the series. Further vaccine immunogenicity and safety follow-up are ongoing.

An interim safety and immunogenicity report, based on blood samples collected from participants one month post-second vaccination, is expected mid-year 2017.

                       
About the Phase I Clinical Study Design
The Phase I study is designed to assess the safety and tolerability of VBI’s CMV vaccine candidate in approximately 125 healthy CMV-negative adults. The study will also determine the vaccine immunogenicity by measuring levels of vaccine-induced CMV neutralizing antibodies, which may prevent CMV infection.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT02826798.

About the Data and Safety Monitoring Board
The DSMB was formed with key opinion leaders, a statistician, and experts in safety in clinical studies of this nature. The board is an arms-length committee that monitors the clinical study to assess safety data at various time points during the clinical study, and to recommend to VBI whether to continue, modify, or stop the study.

About CMV
CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and mental retardation. CMV affects more live births than Down syndrome or fetal alcohol syndrome, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement.


About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac™, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac™ is approved for use in Israel and 14 other countries. VBI’s eVLP Platform technology enables the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

·        Website Home: https://www.vbivaccines.com/  
·        News and Insights: https://www.vbivaccines.com/wire/
·        Investors: https://www.vbivaccines.com/investors/  


VBI Contact
Perri Maduri, Communications Executive
Phone: (617) 830-3031

VBI Investor Contact
Nell Beattie
Director, Corporate Development and Investor Relations

Cautionary Statement on Forward-looking Information
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “may”, “plan”, “will”, “suggesting”, “expected”, and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: plans for Phase III clinical studies, the provision of additional information about clinical studies, the safety and tolerability of the congenital CMV vaccine candidate, the provision of an interim safety and immunogenicity report, and the potential effects of Sci-B-Vac™.

Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company’s products, including the receipt of necessary regulatory approvals; general economic conditions; competitive conditions; and changes in applicable laws, rules and regulations.

Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company’s products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company’s reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions.

Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.


Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Contact each company directly regarding content and press release questions. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp. Disclosure – the following is a paid news release for VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) Learn more about our newswire . pricing and how to publish your news- http://www.investorideas.com/News-Upload/
Additional info regarding BC Residents and global Investors: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.


Friday, April 28, 2017

New Biotech Stocks Added to Investor Ideas Directory; (NASDAQ: $AZRX), (OTC: $ASDS), (NYSE: $AUXO)


New Biotech Stocks Added to Investor Ideas Directory; (NASDAQ: $AZRX), (OTC: $ASDS), (NYSE: $AUXO)



Point Roberts, WA, Delta BC – April 28, 2017 – Investorideas.com, a global news source and investor resource covering actively traded sectors announces this week’s additions to its investor membership, including global stock directories in biotech, technology and mining.

Investorideas.com tracks companies in high profile trading sectors and makes ongoing additions to its stock directories for each sector.  Listing for the stock directories include companies on the TSX, OTC, NYSE, NASDAQ and global stock exchanges.

This week’s biotech additions include a company developing recombinant proteins for the treatment of gastrointestinal diseases and microbiome related conditions; an investment firm that acquires and manages community-based pharmacies and a tech company that provides IT security to the healthcare industry.

Investorideas.com global stock directories are part of the membership program on the site, accessed either by login and password or available in PDF format.  The directories include stocks trading on the TSX, OTC, NASDAQ, NYSE and other recognized global stock exchanges, giving retail investors a wide variety of stocks to review. http://www.investorideas.com/membership/

The directories are not meant as recommendations but as a research tool to discover opportunities and trading ideas in a particular sector.

Read this release in full at

About Investorideas.com - News that Inspires Big Ideas
Investorideas.com is a meeting place for global investors, featuring news, stock directories, video, podcasts, company profiles, interviews and more in leading sectors.

Sectors we cover include tech, bitcoin and blockchain, biotech, mining, energy, renewable energy, water stocks, marijuana and hemp stocks, food and beverage (including organic and LOHAS, wine), defense and security (including biometrics), Latin America, sports, entertainment, luxury brands and gaming.

The Investorideas.com content portfolio goes beyond the www.investorideas.com site to include 12 blogs on Blogger.com, 7 Artificial Intelligence (AI) websites on the Grid and the Waternewswire.com, all featuring Investorideas.com news and content.

Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
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Investor Ideas Directories for global investors:
From water stocks to gold and mining stocks, renewable energy, nanotech, defense, technology, biotech and more – use our stock directories and access them online 24/7 with login as a member to find your next big idea!

Services for Publicly traded companies: http://www.investorideas.com/Investors/Services.asp

Investorideas.com CSE service provider directory listing: http://thecse.com/en/services/services-for-listed-companies

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated for news publication and distribution,social media and marketing, content creation and more. Contact each company directly regarding content and press release questions. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp.

Additional info regarding BC Residents and global Investors: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894.  Global investors must adhere to regulations of each country.

Contact Investorideas.com
800-665-0411
















Wednesday, April 26, 2017

Investor Ideas Podcast Corner; Dr. Sarath Malepati, Creator of the EZC Pak Talks about the Growing Antibiotic Resistance Crisis

Investor Ideas Podcast Corner; Dr. Sarath Malepati, Creator of the EZC Pak Talks about the Growing Antibiotic Resistance Crisis

Point Roberts, WA, Delta BC -April 26, 2017 – Investorideas.com, a global news source covering biotech and LOHAS,  releases a new Podcast interview with  Dr. Sarath Malepati, a leading expert and creator of the new over the counter supplement EZC Pak  https://www.ezcpak.com/ which is the first physician formulated immune support pack designed to reduce inappropriate antibiotic use. 


Dr. Sarath Malepati- creator of EZC Pak


To hear more Investorideas.com podcasts visit: http://www.investorideas.com/Audio/.

Investorideas.com podcasts are also available on iTunes, Google Play Music, Stitcher and Tunein.



About Investorideas.com - News that Inspires Big Ideas
Investorideas.com is a meeting place for global investors, featuring news, stock directories, video, podcasts, company profiles, interviews and more in leading sectors.
Sectors we cover in include tech, bitcoin and blockchain , biotech, mining, energy, renewable energy, water stocks, marijuana and hemp stocks, food and beverage (including organic and LOHAS, wine), defense and security including biometrics, Latin America, sports, entertainment, luxury brands and gaming.

The Investorideas.com content portfolio goes beyond the www.investorideas.com site to include 12 blogs on Blogger.com, 7 Artificial Intelligence (AI) websites on the Grid and the Waternewswire.com, all featuring Investorideas.com news and content.

Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook http://www.facebook.com/Investorideas

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Contact each company directly regarding content and press release questions. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers.

Additional info regarding BC Residents and global Investors: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.

Contact Investorideas.com
800-665-0411


BiotechIndustryStocks.com - investing ideas in biotechnology stocks, medical technology and life sciences



Like Biotech Stocks? View our Biotech Stocks Directory    Get News Alerts on Biotech Stocks

Aesthetic Medical Market News; RepliCel (OTCQB: $REPCF) (TSXV: $RP) Reports US Patent Issued for Novel Dermal Injection Technologies

Aesthetic Medical Market News; RepliCel (OTCQB: $REPCF) (TSXV: $RP) Reports US Patent Issued for Novel Dermal Injection Technologies

"We are confident RepliCel's extensive patent estate for its cell therapy and injection devices will provide our products with long-term market exclusivity," -Lee R. Buckler, CEO




VANCOUVER, BC - April 26, 2017 (Investorideas.com Newswire) Aesthetic Medical Market News alert ; RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) ("RepliCel" or the "Company"), a clinical stage regenerative medicine company developing cell therapies for aesthetic and orthopedic conditions, today announced the granting of a key patent in the United States (U.S. Patent No. 9,616,182) covering significant components of the Company's novel, multi-needle dermal injection device.



Tuesday, April 25, 2017

Four Stocks Competing in the Medical Aesthetic Market; (NYSE: $AGN), (OTCQB: $REPCF) (TSXV: $RP), (NASDAQ: $HOLX), (ZLTQ)

Four Stocks Competing in the Medical Aesthetic Market; (NYSE: $AGN), (OTCQB: $REPCF) (TSXV: $RP), (NASDAQ: $HOLX), (ZLTQ)


Point Roberts, WA, -April 25, 2017 – Investorideas.com, a global news source covering biotech and medical technology, issues a sector close–up on publicly traded companies competing in the rapidly growing medical aesthetic market.

Company news from Allergan (NYSE: AGN), RepliCel (OTCQB:REPCF) (TSXV:RP), Hologic (NASDAQ: HOLX) and ZELTIQ Aesthetics, Inc. (NASDAQ:  $ZLTQ) showcases recent developments in the sector.


Breaking RepliCel (OTCQB: $REPCF; TSX: $RP.V) @RepliCel News; US Patent Issued to for its Novel Dermal Injection Technologies

Breaking RepliCel (OTCQB: $REPCF; TSX: $RP.V) @RepliCel News; US Patent Issued to for its Novel Dermal Injection Technologies

With exclusive U.S. rights to RCI-02 patents, RepliCel edges its nearest-term commercial asset closer to launch in large aesthetic market



VANCOUVER, BC – April 25, 2017 - (Investorideas.com Newswire) RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing cell therapies for aesthetic and orthopedic conditions, today announced the granting of a key patent in the United States (U.S. Patent No. 9,616,182) covering significant components of the Company’s novel, multi-needle dermal injection device. 








Read this release in full at http://www.investorideas.com/news/2017/biotech/04251REPCF.asp