NDA for Aeterna Zentaris' (AEZS) Macrilen™ Granted December 30, 2017 PDUFA Date

Posted by Karen Goldfarb

July 19, 2017 at 11:23 AM

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. 

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Topics: AEZS, Macrilen

GeoVax Labs. (GOVX-OTC) Reports Promising Results for Lassa Fever Vaccine

Posted by Karen Goldfarb

July 11, 2017 at 4:27 PM

Promising Results Reported for GeoVax's Lassa Fever Vaccine

GeoVax announced today a significant step forward in developing its vaccine candidate for protection against Lassa hemorrhagic fever virus (LASV). Efficacy testing in a murine challenge model (using a LASV reassortant) showed a single dose of the candidate vaccine, GEO-LM01, provided 100% protection to mice infected with a lethal dose of the challenge virus.

During testing, mice were given a single-dose vaccination of GEO-LM01 into muscle tissue, then infected with 1000 Plaque Forming Unit of the challenge virus by intracranial inoculation. All vaccinated mice survived while all unvaccinated mice died within one week of infection. Vaccinated animals produced a strong T cell immune response against LASV at 10 days post vaccination. The study was conducted at the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore, with a repeat of the study confirming the findings.

A member of the Arenaviridae virus family, LASV causes severe and often fatal hemorrhagic illnesses in an overlapping region with Ebola virus (EBOV). Compared to the unpredictable epidemics of filoviruses such as EBOV, LASV is endemic in West Africa with an annual incidence of over 300,000, and leading to 5,000 to 10,000 deaths.

New study data suggests that the annual number of LASV cases may actually be meaningfully higher, with 3 million infections and 67,000 deaths (making upwards of 200 million individuals at risk). There are no treatments or vaccines available today to stem LASV epidemics, even though LASV kills more people in one year than the EBOV did in the last 41 years after its first epidemic in 1976 in West Africa.

GeoVax's GEO-LM01 uses the Company's proven MVA-VLP vaccine platform, which has been shown to be safe and to induce durable antibody and T cell responses in multiple human clinical trials for GeoVax’s prophylactic HIV vaccine. Using the same platform, a single dose of GeoVax’s Ebola vaccine has been shown to protect 100% of rhesus monkeys against death.

GeoVax is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal filoviruses for which no effective vaccine currently exists. In addition to developing the four individual vaccines (EBOV, LASV, SUDV, MARV), the Company’s seeks to combine the vaccines into a single tetravalent vaccine to provide broad protection for individuals at-risk for these viruses.

Lassa fever has a greater human impact than any other hemorrhagic fever virus, except for dengue fever, and despite this clear need, no vaccine has yet entered human clinical trials. GeoVax is now ready for advanced preclinical testing, which could lead to initiation of human clinical trials.

For more information on GeoVax, please refer to our Executive Informational Overview (EIO), issued on June 15, 2017. This EIO is a 80-page report detailing GeoVax's business, product development, strategic relationships, market opportunities, competition, financials, risks, and more. It is available for download below.

Download GeoVax Report 

 

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

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