CVR Medical Corp. announced today that it has completed a Food and Drug Administration De Novo Submission for its “Carotid Stenotic Scan (CSS)” device.  A De Novo Submission allows for a company to receive a “not substantially equivalent” risk-based evaluation for any legally marketed device for which there is no prior, comparable classification. 

The Company's CSS, which is a novel device that uses patented sound wave analysis technology to detect and measure carotid arterial stenosis, fits within the criteria of this FDA filing. Due to U.S. government shutdown, the submission will be reviewed by the FDA upon resumption of government activity.
 
CVR's FDA submission marks the culmination of the Company's many years of product development, design, trials, and organizational preparation, and is necessary for any new device entering the market.

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Learn move about CVR Medical by downloading our Executive Informational Overview (EIO), a 60-page report detailing the Company's business, product development, strategic relationships, market opportunities, competition, financials, risks, and more.

Topics: cvr medical, medical technology company, carotid health, ischemic stroke, Carotid Stenotic Scan (CSS), stenosis, occlusion, stroke, duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), computed tomography angiography (CTA), cerebral angiogram, Henry Ford Hospital, Thomas Jefferson University Hospital, ENTICES Study, Cleveland Clinic, Canon U.S.A., CVM-TSX, CRRVF-OTCQB, transient ischemic attack (TIA), atherosclerosis, Army Research Lab

Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy, lassa, lasv

Crystal Research Associates has released a 17-page Quarterly Update on clinical-stage biotechnology company, GeoVax, Labs Inc. (GOVX-OTC). The report is available for download.

 

 

Snapshot of GeoVax

GeoVax Labs is  developing preventative and therapeutic human vaccines against infectious diseases and cancer. The Company’s patented Modified Vaccinia Ankara Virus-Like Particle (MVA-VLP) technology is the foundation for producing non-infectious virus-like particles (VLPs) from the cells of the individual receiving the vaccine. Producing VLPs in a vaccinated individual mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection should it appear, while maintaining the safety characteristics of a replication-defective vector.

GeoVax is focused on developing vaccines against hemorrhagic fever (HF) viruses (Ebola, Sudan, Marburg, and Lassa), Zika virus (ZIKV), malaria, and human immunodeficiency virus (HIV). The Company also has programs to develop a vaccine to treat chronic Hepatitis B virus (HBV) infection and to apply its MVA-VLP technology to cancer immunotherapy (immuno-oncology). Furthermore, GeoVax is collaborating with Emory University to develop a therapeutic vaccine for human papillomavirus (HPV) infection, with a specific focus on head and neck cancer (HNC). GeoVax believes its expertise is complementary to a range of other human diseases for which there is an unmet medical need, and thus, has plans to expand its pipeline.

GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, and a finalist for Pipelines of Promise at Buzz of BIO 2018.

Key Points

• On November 8, 2018, GeoVax issued an overview of its R&D programs as well as reported its financial results for the quarter ended September 30, 2018.

• During the quarter, GeoVax announced that the U.S. Department of Defense (DoD) had awarded the Company a $2.4 million cooperative agreement in support of its novel Lassa Fever (LF) vaccine development program. This followed a Fast-Track Phase I/II SBIR grant award in April 2018 from the National Institutes of Health (NIH) with an expected budget of up to $1.9 million.

• In November 2018, the Company announced the start of a collaboration to develop a therapeutic vaccine for human papillomavirus (HPV) infection. The collaboration is to include preclinical animal testing of GeoVax’s MVA-vectored HPV vaccine candidates in combination with Swiss-based Virometix’ synthetic HPV vaccine candidate.

• The Company further began a collaboration with Vaxeal Holding SA, expanding its cancer vaccine program to include the design, construction, characterization, and animal testing of vaccine candidates using GeoVax’s MVA-VLP vaccine platform with Vaxeal’s proprietary designed genetic sequences. This project is complementary to the ongoing collaboration with ViaMune for co-developing cancer immunotherapies. In parallel, GeoVax is collaborating with the University of Pittsburgh and their Distinguished Professor, Dr. Olja Finn, using combined technologies for abnormal MUC1-expressing tumors.

• The Company’s collaboration with American Gene Technologies International, Inc. (AGT) for use of GeoVax’s vaccine in combination with AGT’s gene therapy to develop a functional cure for HIV is on track to enter a Phase 1 trial sponsored by AGT. AGT expects the trial to begin during the first quarter of 2019. In October 2018, positive results from the HVTN 114 (the Phase 1 trial of GeoVax’s preventive HIV vaccine) were presented at the HIVR4P conference in Madrid, Spain.

• The Company will be represented at the following upcoming conferences: Fourth International Conference on Vaccines Research and Development, Baltimore, Nov. 12-14 and World Vaccine & Immunotherapy Congress, San Diego, Nov. 28-30.

• At September 30, 2018, GeoVax reported cash balances of $511,242 versus $312,727 at December 31, 2017.

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Visit our Corporate Profile and Key Points pages

for the latest research on GeoVax Labs, Inc.

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Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy, lassa, lasv, Ebola, Sudan, Marburg

GeoVax Labs, Inc. announced today the publication of a manuscript entitled “HIV/AIDS Vaccines: 2018,” authored by Harriet L. Robinson, PhD, GeoVax’s Director of HIV Vaccines and Chief Scientific Officer Emeritus. The paper is published in the peer-reviewed journal Clinical Pharmacology & Therapeutics, a journal of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), and can be viewed at https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.1208. Dr. Robinson provides a comprehensive review of progress toward development of an HIV/AIDS vaccine in the article, including key challenges and lessons learned from completed efficacy trials. 

Despite development of effective antiretroviral therapies (ART), only 49% and 48% of people living with HIV in the U.S. and worldwide, respectively, have drug-controlled infections. Patients without drug-controlled infections develop AIDS and spread the infection. This indicates that for eliminating HIV, there is a need for an effective vaccine to be added to the arsenal of ART. Thus, only with a demonstrated effective HIV/AIDS vaccine can people worldwide avoid the infection, ongoing health risks, and societal impact resulting from this disease. GeoVax is a leader in developing a vaccine for the clade B subtype of HIV prevalent in the Western Hemisphere, Europe, and Japan. The Company's vaccine, GOVX-B11, is currently progressing in human clinical trials with the sponsorship of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).”

GeoVax's development programs are focused on vaccines against HIV as well as Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa), and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy and for therapeutic use in chronic Hepatitis B infections. .

For more information on GeoVax, please refer to our most recent Quarterly Update (https://bit.ly/2x4w4t8) dated August 14, 2018, as well as our Executive Informational Overview (EIO), issued on June 15, 2017 and available for download below.

 

 

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Visit our Corporate Profile and Key Points pages

for the latest research on GeoVax Labs, Inc.

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Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy, lassa, lasv

Restructuring Approved by Shareholders

CVR Medical Corp. recently announced that its Board of Directors held a Special Meeting of the Shareholders to approve, among other things, the Restructuring of the Agreement between CVR Medical Corp. and CVR Global Inc. CVR Medical Shareholders approved the restructuring as well as all other items put forth for a vote.

This restructured agreement calls for the companies to terminate and relinquish the previously agreed upon 50%/50% profit sharing structure in exchange for 30 million shares of CVR Medical Corp. stock and additional royalties associated with the commercialization and future sales of the Company's Carotid Stenotic Scan (CSS) as pictured here —a device which uses low frequency sound wave analysis to non-invasively detect and measure carotid arterial stenosis (narrowing of the blood vessels in the neck that carries blood from the heart to the brain) or occlusion (blockage)—which is the leading risk factor for stroke. As well, the current and future Intellectual Property portfolio pertaining to the CSS will now reside within CVR Medical. The agreement is subject to and will require TSX.V approval, which CVR Medical expects to be forthcoming.

With the approved transaction, CVR Global Inc. is expected to move into a milestone-driven equity-based contractor and, upon achieving the milestones stated below, could become one of the Company’s largest shareholders. These milestones include the:

• Approval and signing of agreement (3 million shares)
• FDA submission (2 million shares)
• FDA clearance/approval (10 million shares)
• Achievement of $50 million in sales from CSS Device Sales (15 million shares)—contingent on a maximum 36-month time frame from initial CSS sale

CVR Global is further expected to be granted a 7% royalty on all CSS device sales, with a 3% royalty on all associated disposable sales. With this transaction, roles are now clearly defined along with the pathway to the CSS market launch.

Announces Proposed Financing

In other recent news, CVR Medical announced that it intends to complete a non-brokered private placement financing of units for gross proceeds of up to C$2 million with a price per Unit of C$0.30 or such other price determined by CVR Medical management in compliance with TSX Venture Exchange pricing regulations.

Each Unit is to consist of one common share and one common share purchase warrant, with each Warrant exercisable to acquire one additional Share at a price of C$0.36 per Warrant Share for a period of five years following the closing date of the Financing. The Warrants will be subject to an acceleration right if on any ten consecutive trading days, beginning on the date that is four months and one day following the Closing Date, the daily closing price of the Shares on the Exchange is at or greater than C$0.50. If the Company exercises its Warrant Acceleration Right, the new expiry date of the Warrants will be the 30^th day following the date on which such notice is given by the Company. The Company expects to pay finder’s fees of up to 6% in cash and 6% in finder’s warrants in connection with the Financing.

Proceeds are expected to be used for ongoing working capital requirements related to the development and commercialization of the Company’s CSS Device. Completion of the Financing is subject to Exchange acceptance and all securities issued pursuant to the Financing will be subject to a hold period of four months as required under applicable securities legislation.

Positive Interim Results Reported From Ongoing Pivotal Trial With CSS Device

The Company further announced advisory staff member Dr. Phillip J. Bendick, PhD, has released an internal report summarizing data from the pivotal clinical trials for the CSS devices in use at Thomas Jefferson University Hospital. In alignment with the previous report released by Dr. Bendick in September 2017, this preliminary report views the initial batch of data points collected within the trial as successful for the substantiation of the device’s value and efficacy.

With the trial ongoing (thus only a partial snapshot of the data), the improvements made to the CSS prior to launch of the pivotal clinical trials has generated enhanced functionality within the clinical setting. The CSS Device is being evaluated in a multi-center pivotal clinical trial to evaluate the system’s specificity and sensitivity for detecting carotid artery disease, compared to the current gold standard – duplex Doppler ultrasound. According to Dr. Bendick, “The early results of the first 144 patients enrolled in the CSS pivotal trial have shown excellent overall accuracy […] these initial results demonstrate the efficacy of the CSS as a tool to detect and guide the appropriate management of clinically important carotid artery disease in order to reduce stroke risk.”

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Learn move about CVR Medical by downloading our Executive Informational Overview (EIO), a 60-page report detailing the Company's business, product development, strategic relationships, market opportunities, competition, financials, risks, and more.

Topics: cvr medical, medical technology company, carotid health, ischemic stroke, Carotid Stenotic Scan (CSS), stenosis, occlusion, stroke, duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), computed tomography angiography (CTA), cerebral angiogram, Henry Ford Hospital, Thomas Jefferson University Hospital, ENTICES Study, Cleveland Clinic, Canon U.S.A., CVM-TSX, CRRVF-OTCQB, transient ischemic attack (TIA), atherosclerosis, Army Research Lab

Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy, lassa, lasv

On August 14, 2018, CVR Medical Corp. (CVM-TSX; CRRVF-OTCQB) announced that it has retained the services of Minneapolis-based medical device consulting firm, JD Lymon Group (www.jdlymon.com), to provide reimbursement guidance and help support CVR's FDA submission of its Carotid Stenotic Scan (CSS) device for U.S. market clearance by providing clinical trial design support.

JD Lymon has more than 70 combined years of medical device and pharmaceutical experience across the firm’s partners, with a focus on accelerating market access through multidisciplinary strategies that address the complex interrelationship between policy, evidence, and practice to optimize the market position of emerging therapies.

Specifically, JD Lymon will be guiding CVR through the complicated and evolving reimbursement landscape. This will be done by designing the clinical trials in support of FDA submission, payer advocacy, and overall medical reimbursement coding needs.

Learn move about CVR Medical by downloading our Executive Informational Overview (EIO), a 60-page report detailing the Company's business, product development, strategic relationships, market opportunities, competition, financials, risks, and more.

Topics: cvr medical, medical technology company, carotid health, ischemic stroke, Carotid Stenotic Scan (CSS), stenosis, occlusion, stroke, duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), computed tomography angiography (CTA), cerebral angiogram, Henry Ford Hospital, Thomas Jefferson University Hospital, ENTICES Study, Cleveland Clinic, Canon U.S.A., CVM-TSX, CRRVF-OTCQB, transient ischemic attack (TIA), atherosclerosis, Army Research Lab

Crystal Research Associates has issued a 13-page Quarterly Update on clinical-stage biotechnology company, GeoVax, Labs Inc. (GOVX-OTC). The report is available for download.

Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy, hpv

Topics: cvr medical, medical technology company, carotid health, ischemic stroke, Carotid Stenotic Scan (CSS), stenosis, occlusion, stroke, duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), computed tomography angiography (CTA), cerebral angiogram, Henry Ford Hospital, Thomas Jefferson University Hospital, ENTICES Study, Cleveland Clinic, Canon U.S.A., CVM-TSX, CRRVF-OTCQB, transient ischemic attack (TIA), atherosclerosis, Army Research Lab

An Executive Informational Overview (EIO) is now available on medical technology company, Precision Therapeutics Inc. (AIPT-NASDAQ). The EIO is a 70-page report detailing Precision Therapeutics' business, product development, strategic relationships, market opportunities, competition, financials, risks, and more. It is available for download below.

Topics: precision therapeutics, aipt, personalized medicine, precision medicine, artificial intelligence (AI), medical fluid waste collection, precision oncology, genomic, bioinformatics, STREAMWAY System, Skyline Medical, D-CHIP™, Helomics® Corporation, TumorGenesis, GLG Pharma

Crystal Research Associates has issued a 16-page Quarterly Update on clinical-stage biotechnology company, GeoVax, Labs Inc. (GOVX-OTC), detailing the Company's recent news and developments, anticipated clinical trial and regulatory filing milestones, and financial position. The report is available for download below.

Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy

Aeterna Zentaris Inc. (AEZS-NASDAQ) announced the Marketing Authorization Application (MAA) for the use of Macrilen™ (macimorelin) to evaluate adult growth hormone deficiency (AGHD) has been accepted by the European Medicines Agency (EMA) for regulatory review. Aeterna seeks to become the future for AGHD management and for Macrilen™ to emerge as the drug that endocrinologists and their staff use as the preferred test for their patients.

Macrilen™ is the first innovation in adult GHD testing in over 50 years. Aeterna believes that the drug could eliminate the testing burden of the current standard, which requires physician-supervised administration and up to double digital patient blood draws over several hours. Macrilen™, an orally available ghrelin agonist, stimulates the secretion of growth hormone from the pituitary gland. Stimulated growth hormone levels are measured in blood samples after oral administration of Macrilen™ for the assessment of growth hormone deficiency (GHD).

AGHD affects roughly 75,000 adults across the U.S., Canada, and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland, and is typically characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life, as well presents a higher risk for cardiovascular issues.

On March 7, 2017, the Pediatric Committee of the EMA agreed to the Company’s Pediatric Investigation Plan (PIP) for Macrilen™, a prerequisite for filing an MAA for any new medicinal product in Europe. The EMA also agreed that the company may defer conducting the PIP until after it filed a MAA for the use of Macrilen™ in AGHD. The start of the EMA review procedure for the MAA has now been confirmed by EMA as November 23, 2017. 

Topics: AEZS, Macrilen

An Executive Informational Overview (EIO) is now available on technology company, ZapGo Ltd (closely held). The EIO is a 68-page report detailing ZapGo's business, product development, strategic relationships, market opportunities, competition, financials, risks, and more. It is available for download below.

Topics: Gen 4 technology, technology, batteries, energy storage device, Carbon-Ion™, C-Ion®, Zap&Go, ZapGo Ltd, proprietary Gen 3 technology, mobile phones, laptop computers, cordless power tools, eletric cars

Crystal Research Associates has issued a 15-page Quarterly Update on clinical-stage biotechnology company, GeoVax, Labs Inc. (GOVX-OTC). The Update details GeoVax's recent news and developments, recent and anticipated clinical trial and regulatory filing milestones, and financial position. As well, the Update follows GeoVax's development, strategic relationships, and market opportunities. It is available for download below.

 

Topics: geovax, vaccines, zika, malaria, aids/hiv, hemorragic fever, hbv, immunotherapy

Aeterna Zentaris Inc. (AEZS-NASDAQ) announced that it has been notified by the U.S. Food and Drug Administration (FDA), that the Company’s New Drug Application (NDA) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017. 

The Company remains confident that the FDA will approve its NDA and, accordingly, is moving forward with preparations to launch the product in the first quarter of 2018. In other news, the Company also announced that Mr. Kenneth Newport is no longer a member of the Board of Directors effective as of July 12, 2017.

Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone. The product candidate has been granted orphan drug designation by the FDA for diagnosis of AGHD. Aeterna owns the worldwide rights to this patented compound and has significant patent protection remaining. The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. Aeterna proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.

AGHD affects roughly 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks. 

Topics: AEZS, Macrilen