A Phase I, Double-blind, Randomized, Placebo Controlled, Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) as a 120 Minute Infusion in Healthy, Normal Subjects

Valortim is the name of the experimental drug that volunteers will receive in this study. Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made immune system molecule) for the treatment of inhalation anthrax (when the infection starts in the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the toxin from doing damage to cells. This study is being conducted to see if Valortim given over 120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase, Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the time when you receive the study medication), Follow-up Phase (the time after you receive the study medication) and Final Visit.

开始日期2010-12-01

申办/合作机构

PharmAthene, Inc.

[+3]

NCT01204866 / Completed临床1期

A Phase I, Open Label, Controlled Study of Valortim® (MDX-1303) and Its Selected Formulation Components When Introduced Percutaneously in Subjects Who Have and Have Not Been Exposed to Valortim Administered Intravenously

The purpose of this study is to determine if Valortim, or one or more of its selected formulation components, induces a wheal reaction when introduced percutaneously.
Two of 4 subjects dosed in a previous study with a modified formulation of Valortim experienced treatment related adverse events which were suggestive of allergic or allergic-like reactions. In order to better characterize these reactions and determine if they represent allergic or allergic-like reactions to Valortim or one or more of its components, skin testing of Valortim and selected components on naïve and Valortim-exposed subjects will be performed in this study

开始日期2010-07-01

申办/合作机构

PharmAthene, Inc.

[+2]

NCT00964561 / Suspended临床1期

A Phase I, Single Blind, Randomized, Placebo Controlled, Drug Interaction Study of Intravenous (IV) Valortim® and Intravenous (IV) Ciprofloxacin in Healthy, Normal Subjects

The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.

开始日期2009-08-01

申办/合作机构

PharmAthene, Inc.

[+4]

100 项与 PharmAthene, Inc. 相关的临床结果

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0 项与 PharmAthene, Inc. 相关的专利（医药）

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项与 PharmAthene, Inc. 相关的文献（医药）

2013-11-01·Clinical and Vaccine Immunology

Increasing the Potency of an Alhydrogel-Formulated Anthrax Vaccine by Minimizing Antigen-Adjuvant Interactions

Article

作者: Fusco, Peter C. ; Hirst, Karie ; Lakey, Jeremy H. ; Soliakov, Andrei ; Ganesan, Ashok ; Watkinson, Allan ; Fuerst, Thomas R. ; LeButt, Chris ; Fleetwood, Kelly

ABSTRACTAluminum salts are the most widely used vaccine adjuvants, and phosphate is known to modulate antigen-adjuvant interactions. Here we report an unexpected role for phosphate buffer in an anthrax vaccine (SparVax) containing recombinant protective antigen (rPA) and aluminum oxyhydroxide (AlOH) adjuvant (Alhydrogel). Phosphate ions bind to AlOH to produce an aluminum phosphate surface with a reduced rPA adsorption coefficient and binding capacity. However, these effects continued to increase as the free phosphate concentration increased, and the binding of rPA changed from endothermic to exothermic. Crucially, phosphate restored the thermostability of bound rPA so that it resembled the soluble form, even though it remained tightly bound to the surface. Batches of vaccine with either 0.25 mM (subsaturated) or 4 mM (saturated) phosphate were tested in a disease model at batch release, which showed that the latter was significantly more potent. Both formulations retained their potency for 3 years. The strongest aluminum adjuvant effects are thus likely to be via weakly attached or easily released native-state antigen proteins.

2012-08-01·Clinical and Vaccine Immunology

Recombinant Protective Antigen Anthrax Vaccine Improves Survival when Administered as a Postexposure Prophylaxis Countermeasure with Antibiotic in the New Zealand White Rabbit Model of Inhalation Anthrax

Article

作者: Elizabeth K. Leffel ; E. Diane Williamson ; Thomas R. Fuerst ; James S. Bourdage ; Peter C. Fusco ; Matthew Duchars

ABSTRACTInhalation anthrax is a potentially lethal form of disease resulting from exposure to aerosolizedBacillus anthracisspores. Over the last decade, incidents spanning from the deliberate mailing ofB. anthracisspores to incidental exposures in users of illegal drugs have highlighted the importance of developing new medical countermeasures to protect people who have been exposed to “anthrax spores” and are at risk of developing disease. The New Zealand White rabbit (NZWR) is a well-characterized model that has a pathogenesis and clinical presentation similar to those seen in humans. This article reports how the NZWR model was adapted to evaluate postexposure prophylaxis using a recombinant protective antigen (rPA) vaccine in combination with an oral antibiotic, levofloxacin. NZWRs were exposed to multiples of the 50% lethal dose (LD50) ofB. anthracisspores and then vaccinated immediately (day 0) and again on day 7 postexposure. Levofloxacin was administered daily beginning at 6 to 12 h postexposure for 7 treatments. Rabbits were evaluated for clinical signs of disease, fever, bacteremia, immune response, and survival. A robust immune response (IgG anti-rPA and toxin-neutralizing antibodies) was observed in all vaccinated groups on days 10 to 12. Levofloxacin plus either 30 or 100 μg rPA vaccine resulted in a 100% survival rate (18 of 18 per group), and a vaccine dose as low as 10 μg rPA resulted in an 89% survival rate (16 of 18) when used in combination with levofloxacin. In NZWRs that received antibiotic alone, the survival rate was 56% (10 of 18). There was no adverse effect on the development of a specific IgG response to rPA in unchallenged NZWRs that received the combination treatment of vaccine plus antibiotic. This study demonstrated that an accelerated two-dose regimen of rPA vaccine coadministered on days 0 and 7 with 7 days of levofloxacin therapy results in a significantly greater survival rate than with antibiotic treatment alone. Combination of vaccine administration and antibiotic treatment may be an effective strategy for treating a population exposed to aerosolizedB. anthracisspores.

2011-12-01·Clinical and Vaccine Immunology

Phase I Study Evaluating the Safety and Pharmacokinetics of MDX-1303, a Fully Human Monoclonal Antibody against Bacillus anthracis Protective Antigen, in Healthy Volunteers

Article

作者: Blanset, Diann ; Lowy, Israel ; Leese, Phillip ; Adamcio, Melany ; Riddle, Valerie ; Meldorf, Matthew

ABSTRACT MDX-1303 (Valortim) is a fully human monoclonal antibody (hMAb) with a high affinity for Bacillus anthracis protective antigen (PA). MDX-1303 binds to PA and interferes with the activity of the anthrax toxin; it was selected based on its superior functional activity in the toxin neutralization activity (TNA) assay. MDX-1303 has demonstrated efficacy in the postexposure and therapeutic settings in New Zealand White rabbits, cynomolgus monkeys, and African green monkeys. This phase I study sought to characterize the safety, tolerability, immunogenicity, and pharmacokinetics (PK)/pharmacodynamics (PD) of MDX-1303 in healthy human subjects. Cohorts of 3 to 10 subjects were administered MDX-1303 as either a single intravenous (i.v.) dose at dose levels of 0.3, 1, 3, 10, and 20 mg/kg of body weight or as a single intramuscular (i.m.) dose at 100 mg. Forty-six subjects were enrolled, and 16 (35%) of these subjects experienced one or more grade 1 adverse events considered to be related to treatment with MDX-1303. There were no grade 2 to 4 adverse events or serious adverse events (SAEs) considered to be related to treatment. The mean half-life of MDX-1303 ranged from 22 to 33 days across the i.v. administration cohorts and was approximately 32 days following i.m. administration. Systemic exposure following 100-mg i.m. administration was within the range of exposure following 1-mg/kg i.v. administration with a relative bioavailability of approximately 65%. MDX-1303 was generally well tolerated, and no anti-MDX-1303 antibodies were detected following a single dose.

项与 PharmAthene, Inc. 相关的新闻（医药）

2024-03-31

·生物制药小编

不靠谱Biotech的减肥药靠谱吗？

近日，Altimmune在其年度财报中宣布将放弃该公司的乙肝药物HepTcell的开发。不过这一消息并未令公司股价下跌，原因在于该公司的核心减肥药物pemvidutide在去年11月展现出了较为优异的数据，更是迎头赶上了减肥药市场的火热，在其他跨界适应症中也展现出了较为优异的疗效。虽然减肥药方面的消息还算不错，但如果放到这家公司整体战略规划中来看，其实会发现这次被放弃的HepTcell的开发过程的行动力和Altimmune在这一过程的战略决策其实相当不靠谱。这或许就让人担心pemvidutide以后也会不会出现同样的问题。HepTcell的“龟速”开发HepTcell是一种基于合成肽的免疫治疗产品，由九种代表乙型肝炎病毒（HBV）保守序列的肽链组成，并与授权获得的IC31佐剂相结合。IC31是由Valneva SE生产的基于TLR9的佐剂，旨在增强免疫反应。HepTcell在2017年时，其实已经有I期临床的初步结果（2015-2018年），2019年报告的I期初步结果不是特别理想，单药疗效似乎微乎其微，安全性方面并无问题。这个时候的抉择可能是放弃这款药物，或者尝试其他开发方式。（下图一为I期临床，图2为II期临床开始时间）图1：HepTcell的I期临床图2：HepTcell的II期临床不过，这个决定直到2020年年末才做出……那时才准备继续开展HepTcell的II期临床。或许部分原因是因为2017年时Altimmune正在与PharmAthene公司合并的过程中……公司合并让这一项目束之高阁。（抑或是担忧临床终止开发会让公司市值缩水？）也或许是因为2019年年末，新冠大流行出现了，虽然官方发布的财报中并没有提及优先级关系，但这家公司似乎优先选择了开发新冠疫苗？这家公司本身有流感疫苗NasoVAX管线（腺病毒疫苗），但因为流感和新冠的症状类似，所以他们的想法同样的技术平台用作鼻腔给药能够在新冠病毒的初始攻击部位诱导免疫反应……因此以这种方式利用新冠的RBD结构域开发了AdCOVID管线，而治疗流感的NasoVAX管线就这样被雪藏了。而不幸的是，2021年6月份时AdCOVID被披露效果不尽如人意，遭到了该公司放弃。可以说这是经典的战略判断失误，赔了夫人又折兵。这样一来一回的折腾，最终这家公司还是笃定在乙肝药HepTcell和减肥药pemvidutide的开发上。不过随后HepTcell的临床招募也是相当缓慢……2020年年末开始临床招募，竟然到2023年4月才堪堪招募了80名患者……而随后就是最近的消息，HepTcell停止开发了……唯一希望的减肥药现在减肥药pemvidutide就成为了这家公司唯一的希望。不过这真的是希望吗？pemvidutide最开始是Altimmune通过收购Spitfire Pharma获得的（当时叫ALT-801），最开始这款药物似乎就没有开发减肥药的打算，第一项适应症确立的是NASH（非酒精性脂肪肝）后来在跟着司美格鲁肽等GLP-1类药物的减肥药适应症开发，这方面可以说是赛道的后来者，也可以说是跟风。而疗效方面，也有人持有反对意见。今年2月做空机构Kerrisdale在做空Altimmune的股票时认为，在减肥和跨界赛道中，pemvidutide在疗效方面竞争不过礼来的替尔泊肽和诺和诺德的司美格鲁肽。近期，财报中发布的pemvidutide的减重中74.5%的体重减轻来自脂肪组织倒是为pemvidutide给出了想对还不错的预期。但这里或许还是有个问题，是否能指望一家行动力不足，战略决策预判错误的公司在激烈赛道中胜出？参考来源：https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-positive-lean-mass-preservation-data

财报并购疫苗临床1期临床2期

2018-10-25

·BioPortfolio

Altimmune to Present at Dawson James Securities 4th Annual Small Cap Growth Conference

GAITHERSBURG, Md., Oct. 26, 2018 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced that Bill Enright, President and Chief Executive Officer will provide a corporate overview at the Dawson James Securities 4th Annual Small Cap Growth Conference being held at the Wyndham Grand Jupiter Hotel, Jupiter, Florida. Details of the presentation are as follows: Dawson James Securities 4th Annual Small Cap Growth Conference Details: Date: Tuesday, October 30, 2018 Time: 4:00 pm Location: Wyndham Grand Jupiter Hotel, Jupiter, Florida About Altimmune Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of infectious disease. NasoVAX our influenza vaccine candidate has unique characteristics, stimulating multiple arms of the immune system that offer the potential to stop infection and the spread of flu, while being easier to administer through an intranasal spray. NasoShield is a next-generation anthrax vaccine candidate that is intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: the terms of the Company’s Series B preferred stock offering and related warrants; our lack of financial resources and access to capital; realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; our ability to utilize the benefits of our tax assets and the results of a tax examination initiated by the IRS; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov. Contacts Bill Enright President and CEO Phone: 240-654-1450 Email: enright@altimmune.com Ashley R. Robinson Managing Director LifeSci Advisors Phone: 617-535-7742 Email: arr@lifesciadvisors.com NEXT ARTICLE More From BioPortfolio on "Altimmune to Present at Dawson James Securities 4th Annual Small Cap Growth Conference" Related Companies Related Clinical Trials Related PubMed Entries Related Medications

疫苗并购

2012-03-06

·BioSpace

PharmAthene, Inc. to Host Year-End 2011 Earnings Conference Call and Webcast on Thursday, March 8, 2012

ANNAPOLIS, Md., March 6, 2012 /PRNewswire/ -- PharmAthene, Inc. (Amex: PIP) a biodefense company developing medical countermeasures against biological and chemical threats, announced today that its financial results for the year ended 2011 will be released on Thursday, March 8, 2012. PharmAthene management will host a conference call to discuss the Company's year-end financial and operational results beginning at 4:15 p.m. Eastern Time on Thursday, March 8, 2012. The dial-in number within the United States is 866-804-6920. The dial-in number for international callers is 857-350-1666. The participant passcode is 14054571. A replay of the conference call will be available for 30 days, beginning at approximately 6:30 p.m. Eastern Time on Thursday, March 8, 2012. The dial-in number from within the United States is 888-286-8010. For international callers, the dial-in number is 617-801-6888. The participant passcode is 14695588. The conference call will also be webcast and can be accessed from the company's website at . A link to the webcast may be found under the Investor Relations section of the website. SOURCE PharmAthene, Inc.

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