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Pentikis H.S.,SAJE Consulting LLC | Matson M.,Prism Research Inc. | Atiee G.,ICON Development Solutions | Boehlecke B.,Rho Inc. | And 5 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2011

FV-100 is the prodrug of the highly potent anti-varicella zoster virus bicyclic nucleoside analogue CF-1743. To characterize the pharmacokinetics and safety of oral FV-100, 3 randomized, double-blind, placebo-controlled clinical trials were conducted: (i) a single-ascending-dose study in 32 healthy subjects aged 18 to 55 years (100-, 200-, 400-, and 800-mg doses) with an evaluation of the food effect in the 400-mg group; (ii) a multiple-ascending-dose study in 48 subjects aged 18 to 55 years (100 mg once daily [QD], 200 mg QD, 400 mg QD, 400 mg twice a day, and 800 mg QD for 7 days); and (iii) a 2-part study in subjects aged 65 years and older with a single 400-mg dose in 15 subjects and a 400-mg QD dosing regimen for 7 days in 12 subjects. FV-100 was rapidly and extensively converted to CF-1743, the concentration of which remained above that required to reduce viral activity by 50% for the 24-hour dosing period. Renal excretion of CF-1743 was very low. A high-fat meal reduced exposure to CF-1743; a low-fat meal did not. Pharmacokinetic parameters for the elderly subjects were comparable to those for the younger subjects. FV-100 was well tolerated by all subjects. The pharmacokinetic and safety profiles of FV-100 support its continued investigation for the treatment of herpes zoster and prevention of postherpetic neuralgia with once-daily dosing and without dose modifications for elderly or renally impaired patients. Copyright © 2011, American Society for Microbiology. All Rights Reserved.


BOCA RATON, FL--(Marketwired - November 14, 2016) - Noble Life Science Partners, a division of Noble Financial Capital Markets (Noble) announced today that Nathan Cali, formerly Noble's specialty pharmaceuticals senior analyst, has moved to its investment banking department. The move was timed to coincide with Noble's Investor Conference -- NobleCon13 to be held at the Boca Raton Resort & Club, January 30-31, 2017. Life science companies represent a significant portion of the presenting company roster at the conference. The sector is so important to Noble that it moved the date of the 2017 NobleCon back by two weeks in order to avoid a conflict with the JP Morgan Healthcare Conference set for early January in San Francisco. Mr Cali joined Noble in 2008 after gaining experience at Andrx Pharmaceuticals and Franklin Templeton. "As a senior analyst at Noble, Nathan has exhibited a "nose" for finding compelling investment ideas and themes for investors," said Noble's CEO Nico P. Pronk. A good example is a company that was recently acquired -- Cynapsus Therapeutics, Inc. for $624 million USD. In 2013, when the company's market capitalization was only $13.9 million, Noble was the first to initiate equity research coverage. Since that time, Cali has published 30 Cynapsus research reports and the company has attended two NobleCon Conferences. Noble has also supported the company's growth in investor awareness through three rounds of financing totaling in excess of $100 million USD, and through numerous non-deal road shows targeting fundamental science-driven institutional investors. Cynapsus is not the only company that has shown substantial growth. For example, Cali initiated coverage of TherapeuticsMD in 2013 when its market capitalization was $200 million, today it hovers around $1.0 billion; Axogen has grown from $28 million since initiation of research coverage in 2012 to over $280 million today. Cali also was early in identifying opportunities in the Hepatitis C space; Pharmasset's market cap was $173 million when he initiated -- the company was purchased a few years later by Gilead for $11 billion, and; Inhibitex was acquired by Bristol Myers Squibb for $2.5 billion and had a market capitalization in 2009 of $13 million when Noble initiated coverage. Cali was also instrumental in the creation (co-founder) of Variant Pharmaceuticals; a private early-stage life sciences company that will be entering into Phase 1 studies on the path to the commercialization of products designed to treat rare progressive forms of kidney disease. Noble believes that Mr. Cali's strong analytical healthcare background will provide great value to corporations in need of financing and strategic advice, and will further enhance our investment banking capabilities in the Noble Life Science Partners division. About Noble Financial Capital Markets Noble Financial Capital Markets established in 1984, is an equity-research driven, full-service, investment & merchant banking boutique focused on the healthcare, media & entertainment, technology and natural resources sectors. The company has offices in Boca Raton (HQ), New York and Boston. In addition to the annual multi-sector NobleCon, each year Noble hosts numerous "non-deal" corporate road shows and sector-specific conferences such as the Media, Finance & Investor Conference offered in partnership with the National Association of Broadcasters (NAB).


News Article | February 28, 2017
Site: globenewswire.com

Elects Dr. Russell Medford to its board of directors RANCHO CORDOVA, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), a market leader in automated cell processing and point-of-care autologous cell-based therapies, today announced that it has appointed Ms. Vivian Liu as its Chief Operating Officer and elected Dr. Russell Medford to its board of directors. Ms. Vivian Liu, a member of Cesca’s board of directors since November 2016, has over 20 years of experience in finance, operations and M&A activities for private and public pharmaceutical companies. Prior to joining Cesca, Ms. Liu was the Managing Director of OxOnc Services Company, an oncology product development company.  From 1994-2010, she served in various executive roles at NexMed, Inc., which she co-founded and was later renamed Apricus Biosciences Inc. Ms. Liu obtained her MPA in International Finance from the University of Southern California and her B.A. from the University of California, Berkeley. Dr. Russell Medford is a Managing Partner of the Salutramed Group, LLC and has extensive private and public company expertise. He is also currently the CEO of healthEgames, Inc., a digital healthcare company and serves as the Executive Chairman of ViaMune, Inc., which is developing new immuno-oncology therapies. Dr. Medford has served as the co-founder, President, CEO and Director of AtheroGenics, Inc. and was a founding board member of Inhibitex, Inc. serving on its board until its acquisition by Bristol-Myers-Squibb in 2012. He has led companies through multiple stages of therapeutic drug R&D developing novel, first-in-man clinical candidates for the treatment of cardiovascular disease, diabetes and arthritis. Dr. Medford obtained his M.D. and Ph.D. from the Albert Einstein College of Medicine. “We are very pleased to have Vivian join the Cesca leadership team. Vivian has been a board member since November and with her diverse corporate finance and operations experience, the board is enthusiastic to have her take a much more involved role in the Company’s operations.” commented Dr. Xiaochun "Chris" Xu, Cesca's Interim CEO. “Dr. Medford, who has a deep knowledge of drug development and clinical trials, will be of great value to the company as we continue to evaluate our clinical pipeline and prepare for our phase III trial in critical limb ischemia.  We look forward to working with both Vivian and Dr. Medford to help position Cesca as a leader in the broader healthcare industry.” About Cesca Therapeutics Inc. Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include: Forward-Looking Statement The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.


Kaufman D.A.,University of Virginia | Morris A.,Inhibitex | Gurka M.J.,West Virginia University | Kapik B.,Inhibitex | Hetherington S.,Icagen Inc.
Early Human Development | Year: 2014

Background: Fluconazole prophylaxis has demonstrated efficacy in single and multicenter randomized controlled trials without side effects or emergence of resistance. Additional evidence based on incidence of invasive Candida infections, multicenter data, resistance, and safety is desired. Methods: We conducted a case-control analysis of efficacy and safety of fluconazole prophylaxis from a multicenter database from a neonatal infection study that included 2017 infants <1250 grams from 95 NICUs. Infants receiving intravenous antifungal prophylaxis were pre-identified during enrollment in the parent study. For each infant receiving antifungal prophylaxis (case), three infants not receiving antifungal (controls) were matched by birth weight (±50 g), by gestational age (±1 week), gender, and study site. Results: Fluconazole prophylaxis was administered to 127 patients [754±163 g birth weight (BW) and 25.4±1.7 weeks gestational age (GA)] and were compared with 399 control patients (756±163 g BW and 25.5±1.8 weeks GA). Invasive Candida infection occurred in 0.8% (1 of 127) infants who received fluconazole prophylaxis compared with 7.3% (29 of 399) of matched controls (p = 0.006). Candida bloodstream infection occurred in 0.8% (1 of 127) fluconazole prophylaxis infants compared with 5.5% (22 of 399) of matched controls (p = 0.02). There were no differences in late-onset sepsis due to gram-positive or gram-negative organisms, focal bowel perforation, necrotizing enterocolitis, cholestasis, or overall mortality. Conclusion: Fluconazole prophylaxis is safe and efficacious in preventing invasive Candida infections. Even in NICUs with a low incidence of invasive Candida infections, antifungal prophylaxis for high-risk infants is a proven and safe opportunity for infection prevention in these patients. © 2014 Elsevier Ireland Ltd.


This invention is directed to novel compounds of formula (I) having the structure (I) wherein U, V, W, Z, R^(1), X^(1), X^(2), and Y are defined herein. The compounds of formula (I) and pharmaceutical compositions containing these compounds are useful in the treatment of viral infections in mammals mediated, at least in part, by a virus in the Flaviviridae family of viruses, in particular hepatitis C virus (HCV).


Polyclonal and monoclonal antibodies which are cross-reactive to both coagulase-positive staphylococcus bacteria, such as S. (hemolyticus), are provided which can recognize surface proteins from both coagulase-positive and coagulase negative staph bacteria. The antibodies may be generated from surface proteins that have been isolated on the basis of characteristics that may be common between S. (aureus) and coagulase-negative staphylococci, and these recombinant surface proteins are used to generate the antibodies of the invention. There is also provided vaccines and methods which utilize these proteins and antibodies for the treatment or protection against a wide variety of staphylococcal infections.


Patent
Inhibitex, Bioresearch Ireland and Texas A&M University | Date: 2011-05-11

Isolated extracellular matrix-binding proteins, designated ClfB, SdrC, SdrD and SdrE, and their corresponding amino acid and nucleic acid sequences and motifs are described. The proteins, peptides, fragments thereof or antigenic portions thereof are useful for the prevention, inhibition, treatment and diagnosis of $i(S. aureus) infection and as scientific research tools. Further, antibodies or antibody fragments to the proteins, peptides, fragments thereof or antigenic portions thereof are also useful for the prevention, inhibition, treatment and diagnosis of $i(S. aureus) infection. In particular, the proteins or antibodies thereof may be administered to wounds or used to coat biomaterials to act as blocking agents to prevent or inhibit the binding of $i(aureus) to wounds or biomaterials. C1fB is a cell-wall associated protein having a predicted molecular weight of approximately 88 kDa and an apparent molecular weight of approximately 124 kDa, which binds both soluble and immobilized fibrinogen. C1fB binds both the alpha and beta chains of fibrinogen and acts as a clumping factor. SdrC, SdrD and SdrE are cell-wall associated proteins that exhibit cation-dependent ligand binding to the extracellular matrix. It has been discovered that in the A region of SdrC, SdrD, SdrE, C1fA and C1fB, there is a highly conserved amino acid sequence that can be used to derive a consensus motif of TYTFTDYVD.


Polyclonal and monoclonal antibodies which are cross-reactive to both coagulase-positive staphylococcus bacteria, such as S. (hemolyticus), are provided which can recognize surface proteins from both coagulase-positive and coagulase negative staph bacteria. The antibodies may be generated from surface proteins that have been isolated on the basis of characteristics that may be common between S. (aureus) and coagulase-negative staphylococci, and these recombinant surface proteins are used to generate the antibodies of the invention. There is also provided vaccines and methods which utilize these proteins and antibodies for the treatment or protection against a wide variety of staphylococcal infections.


This invention is directed to compounds of Formula (I) having the structure that are useful in the treatment of viral infections in mammals, particularly in humans, mediated, at least in part, by a virus in the Flaviviridae family of viruses.


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