News Article | March 2, 2017
WALTHAM, Mass.--(BUSINESS WIRE)--OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, today reported financial results and provided a business update for the fourth quarter and year ended December 31, 2016. “We are entering 2017 with continued confidence in our portfolio of potentially transformative fertility treatments and a strong belief in the potential of our EggPC platform to help women and couples build the families they deserve,” said Michelle Dipp, M.D., Ph.D., Executive Chair and Co-Founder of OvaScience. “In 2016, we achieved criteria indicative of developmental competence in EggPC cell-derived bovine and human eggs, an important step in the preclinical development of OvaTure, and we are on track to successfully fertilize a bovine EggPC cell-derived egg by year-end,” added Christophe Couturier, Chief Financial Officer. “We are also pleased to have enrolled the first 50 patients in our company-sponsored trial of OvaPrime, and to have started performing the first biopsies and reintroductions. With these milestones in hand, we remain on track to report initial data on our first 20 patients from this study by year-end. We are sufficiently funded to support the preclinical development of OvaTure and clinical development of OvaPrime into the first quarter of 2019.” OvaTureSM Treatment: The Company today reviewed progress for OvaTure, its potential next-generation in vitro fertilization (IVF) treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections by maturing egg precursor (EggPC SM) cells into eggs in vitro. There are a choreographed series of events that occur during egg maturation to prepare an egg for fertilization. Collectively, these can be described as developmental competence. Together with its partner, Intrexon Corporation (NYSE: XON), OvaScience has developed an in vitro cell culture process that has produced bovine and human eggs derived from EggPC cells that exhibit genetic, morphological and functional criteria of developmental competence during various phases of maturation. These criteria include: chromosomal segregation; an increase in cytoplasmic volume; the appearance of germinal vesicles, polar bodies and zona pellucida structures; and a positive brilliant cresyl blue (BCB) test. Fertilization studies for bovine EggPC-cell derived eggs are underway and OvaScience and Intrexon expect to successfully fertilize a bovine EggPC-derived egg by year-end. OvaScience will continue to work with its clinical partners to develop a repeatable and robust process for the maturation of eggs derived from human EggPC cells and to secure authorization to fertilize human EggPC cell-derived eggs and embryos by the end of the first half of 2018. OvaPrimeSM Treatment: The Company announced milestone achievements for OvaPrime, a potential fertility treatment that could enable a woman who makes too few or no eggs to increase her egg reserve. In December 2016, OvaScience announced its decision to continue the development of OvaPrime. OvaScience is currently evaluating OvaPrime in a prospective, blinded, randomized and controlled Company-sponsored trial, which is designed to assess the safety of OvaPrime and changes in a patient’s hormone levels and follicular development as measured by ultrasound. The trial will enroll 70 women with either diminished ovarian reserve (DOR) or primary ovarian insufficiency (POI). To date, the Company has enrolled 50 patients and expects to enroll an additional 20 women by the end of the first half of 2017. OvaScience recently completed the first biopsies and reintroductions in this ongoing clinical trial in Canada. The Company remains on track to announce initial data from the first 20 patients, including six months of post-EggPC reintroduction safety data, by year-end. AUGMENT SM Treatment: The Company maintained its commercial footprint for AUGMENT, a treatment designed to improve egg health and with that, IVF success rates, by using mitochondria from a woman’s own EggPC cells during IVF. In December 2016, the Company announced that it will continue to make AUGMENT available to patients at clinics in Canada and Japan and will expand regionally on a limited basis as appropriate. Also announced in December 2016, the Company is reassessing its clinical development strategy for AUGMENT, including its planned multi-center clinical trial and the ongoing IVI-sponsored study in Valencia, Spain. Separately, OvaScience will meet with the U.S. Food and Drug Administration (FDA) in the first half of 2017, as part of its ongoing exploration of potential entry into the U.S. market. The Company expects to achieve the following milestones in 2017: At December 31, 2016, OvaScience had cash, cash equivalents and short-term investments of $114.4 million. OvaScience expects one-time cash expenditures of approximately $5.7 million to $6.5 million over 2017 and 2018 related to actions resulting from the corporate restructuring announced in December 2016. The Company may also incur further restructuring charges related to the restructuring plan. OvaScience’s operating cash burn for 2017 is expected to be between $45 million and $50 million, which excludes these one-time cash expenditures. OvaScience anticipates that it will have sufficient funds, without additional financing, to support its operating plan into the first quarter of 2019. Conference Call OvaScience will host a conference call at 4:30 p.m. ET today, Thursday, March 2, 2017, to discuss these financial results and provide an update on the Company. The conference call may be accessed by dialing +1-888-424-8151 for U.S. callers and +1-847-585-4422 for international callers five minutes prior to the start of the call and providing the passcode 7862456. Additionally, the live, listen-only webcast of the conference call can be accessed by visiting the Investors section of the Company’s website at www.ovascience.com. A replay of the conference call will be available from 7:00 p.m. ET on Thursday, March 2, 2017 through 11:59 p.m. ET on Thursday, March 9, 2017, and may be accessed by visiting OvaScience’s website or by dialing +1-888-843-7419 for U.S. callers and +1-630-652-3042 for international callers. The replay access code is 7862456#. About OvaScience OvaScienceSM, Inc. (NASDAQ: OVAS) is a global fertility company dedicated to improving treatment options for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because it believes women deserve more options. Each OvaScience treatment is based on the Company’s proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. OvaScience is developing OvaTureSM, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections and OvaPrimeSM, which could increase a woman’s egg reserve. OvaScience’s AUGMENTSM treatment, a fertility option designed to improve IVF success rates, is available in certain IVF clinics in select international regions. OvaScience treatments are not available in the U.S. For more information, visit www.ovascience.com. Forward-Looking Statements This press release includes forward-looking statements about the Company’s plans for the OvaPrime treatment, OvaTure treatment and AUGMENT treatment, including statements relating to the Company’s plans to fertilize a bovine EggPC cell-derived egg by year-end; to complete enrollment of all 70 patients in the ongoing Canadian study of OvaPrime by the end of the first half of 2017; to complete biopsies in all patients in the ongoing Canadian study of OvaPrime by year-end; to present initial data from 20 OvaPrime patients, including six months of post-EggPC reintroduction safety data, by year-end; availability of sufficient funding to support the preclinical development of OvaTure and clinical development of OvaPrime into the first quarter of 2019; the Company’s further efforts on human egg maturation, the Company’s plans to work with its clinical partners in pursuit of its goals to develop a repeatable and robust process for the maturation of eggs derived from human EggPC cells and to secure authorization to fertilize human EggPC cell-derived eggs and embryos by the end of the first half of 2018; and the Company’s plans to meet with the U.S. Food and Drug Administration in the first half of 2017. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the science underlying our treatments (including the OvaPrime, OvaTure and AUGMENT treatments), which is unproven; our ability to obtain regulatory approval or licenses where necessary for our treatments; our ability to develop our treatments on the timelines we expect, if at all; our ability to commercialize our treatments, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.
News Article | March 16, 2016
When gene drives go to war Public opinion is shaped by the way science is communicated. The metaphors that we choose can have a powerful role in this process, with the ability to inspire or to horrify, to enlighten or to confuse. Synthetic Biology is saturated with metaphors, and as an emerging field dealing with controversial issues such as gene editing, practitioners face a difficult task in getting it right. A couple of weeks ago we [Steven Burgess, Carmen McLeod and Brigitte Nerlich] sat down together to discuss working on a post for the PLOS Synbio Community blog. We wanted to write something about the way gene drives are described, as is one of the more controversial topics in synthetic biology. Because our meeting was at the height of media attention to the spread of the Zika virus across Southern America, particularly Brazil, we thought it might be a good idea to look at what people were saying about gene drives in the context of Zika. Brigitte then did one of her quick trawls through 'All English Language News' on the Nexis news database – more about that later – and was surprised to find that the metaphor of war was a major framing device when talking about gene drives in the context of Zika. Brigitte was corresponding with Kate Roach, a Frankenstein specialist, who suggested some nice spoof headlines, one of which we used for this post. Steven then wrote our spoof first paragraph, which summarises the essence of some of the Zika/biotech discourse that one can find 'out there' and we were off! In the following we'll provide a bit of background to Zika and gene drives, then home in on the war metaphors we found, before discussing some of their social, ethical and political implications. The Zika virus was first identified in monkeys in Uganda in 1947 – rhesus monkeys that lived in a forest called Zika. It gradually spread from Africa to Central America. The virus is carried by the Aedes aegypti mosquito which has also been linked to transmitting dengue fever, yellow fever and chikungunya. In May 2015 the Zika spreading mosquitoes reached Brazil, where the virus, which until then only caused mild discomfort, is suspected to be linked to a large cluster of microcephaly cases (evidence is getting stronger) and has, more recently been linked to Guillain-Barré syndrome too. It has now been discovered that the virus can be transmitted sexually and even through saliva. The mosquitoes that transmit the virus through their bite are female and thrive in urban surroundings in particular, especially in pools of stagnant water. There are many options to deal with the virus and its vector – the mosquito -, from citizen science and on the ground activities like spraying pesticides and eliminating pools of stagnant water, to experimental genetic modification of mosquitoes (making males sterile or even inducing sex change from female to male), to more futuristic interventions that could wipe out the insect population as a whole – through the use of a technology called 'gene drive'. A 'gene drive' is a recent development in biotechnology. Although the concept has been around for a while, it is an advanced application of genetic modification based on an existing genome editing tool, called CRISPR-Cas9, that allows scientists to precisely insert, replace, delete or regulate genes in many different species. A gene drive enables a quick and persistent spread of a genetic trait within a population of a particular organism. This is especially feasible in organisms with a short generation time, and gene drives are only effective in sexually reproducing organisms. However, as the government response to the report on genetically modified insects by the House of Lords Science and Technology Select Committee has pointed out: "With gene-drive technology still at a relatively early stage of development, it is likely to be some years before any proposal may be forthcoming for a field release of a gene-drive insect." (p. 4) In the context of dealing with dengue fever, some GM insects have been developed in particular by the British firm Oxitec, now part of the US company Intrexon. The insects are genetically modified to be sterile, but don't contain a gene-drive. The language used on Oxitec's website to describe the technology makes for interesting reading. Oxitec describes its own insect-killing gene-technology using metaphors that overlap to some extent with the war metaphors we found in our little corpus, together with some machine metaphors typical of synthetic biology: "The Oxitec approach is to insert a lethal factor (a gene) into the insect's genome. The insect's offspring inherit the lethal factor, so that in the environment they will not survive to adulthood." And: "The lethal factor is a gene which is able to act as a switch to control the activity of other genes. In the modified insects, the presence of high levels of this gene causes the machinery in the insect's cells to go into over-drive. The gene doesn't produce any toxic proteins, but it ties up some of the cell's essential machinery and disrupts its normal function – causing the insects to die. Because no toxic proteins are produced in the insects, when any other animals eat them they will be digested in just the same way that all other insects are digested, so natural predators won't suffer any harmful effects from consumption of a modified insect." The GM insects are described as machines that include switches, have machinery and can go into overdrive. But they are not just machines – they are lethal machines. Initially developed to 'fight' dengue fever in Brazil, this technology is now becoming part of the 'arsenal' deployed against Zika's 'explosive' spread. In the English media Zika seems to have been discussed since the 1990s, but especially around 2007, when people began to monitor its worldwide spread. At the end of 2015 possible links with microcephaly were noticed and Brazil declared a public health emergency on 11 November 2015. Our graph starts on 15 January 2016, when the US Centers for Disease Control issued a travel alert. On 28 January the World Health Organization (WHO) talked about an 'explosive spread', and and in a twitter message Brazilian President Dilma Rousseff declared war on mosquitoes responsible for spreading the Zika virus (first peak in our graph). On 1 February the WHO declared a public health emergency of international concern and sexual transmission of Zika is beginning to be discussed (leading to the highest peak in our graph). On 10 February strong evidence links Zika to microcephaly (third peak in our graph). On 16 February the WHO announced that it supported research into the use of GM mosquitoes as tools control the Zika outbreak. In order to get a very quick and dirty insight into how gene drives are being discussed in the context of the Zika outbreak, we accessed the Nexis database and searched All English Language News with the search terms 'Zika' AND 'gene drive'. This retrieved 58 articles. Of these 21 were online articles (of which 3 were duplicates) and 35 mainstream media articles (of which 15 were duplicates and two not relevant). This provided us with a very small but manageable window on press coverage regarding Zika and gene drives. But, of course, more research needs to be done. When going through the small corpus of articles, we found to our surprise that in the context of the Zika 'threat' GM insects and also gene drives were almost exclusively discussed through the lens of war not science – or rather science becomes a weapon in the war on Zika. In particular, gene drives and GM insects were seen as 'potent weapons' or 'powerful tools', 'GM weaponry', 'means of attack', a 'powerful biotech weapon', or a new tool in the existing 'arsenal'/'artillery' that could be used to 'wipe out' the insects/virus (indeed, 'wipe it off the face of the earth'), 'knock down' the virus, and, of course 'fight' and 'combat' the virus, 'stop it in its tracks' and 'kill' the insects. Gene drives were discussed as a potent 'extinction option' that could be used to launch 'a final blow' against a 'wily foe' that 'spreads bioterror in its wake'. Some even talked about a program of 'Total Mosquito Destruction' and a 'nuclear option'. Three articles in particular used a range of war metaphors. One was written by Daniel Engber for Slate Magazine (29 January). In this article Engber wants to 'give'm hell' and commit 'mass mosquito-cide'. Another more moderate article was written by Michael Reilly for MIT's online Technology Review (29 January) and contains both verbal and visual war imagery. The third article, by Archie Bland for the Guardian (10 February), initially talks not only about 'wiping out' the 'bloodsuckers' but also about 'editing nature' (quoting scientists, it should be stressed). However, this article also quoted other voices that contributed to a more nuanced reflection on the issue. The journalist then wonders (referring not to gene drives but GM insects): "All the same, there is a certain bitter irony that in an attempt to beat a disease whose impact will be felt most keenly by women and their unborn children, and which has been exacerbated by a shortage of funding for studies that would focus on the wellbeing of women in developing countries, we are contemplating a macho solution that entails sending male mosquitoes to impregnate as many females as possible, with the ultimate ambition of wiping the enemy off the face of the Earth." Three more articles contributed to a more critical debate on GM insects and on the potential use of gene drives. One important article was written quite early on by Kevin M. Esvelt which appeared both online and in the mainstream media on 26/27 January and called for responsibility, transparency and collective scrutiny. He also points out: "Nowadays, there are few opportunities for public input until after products are developed, when it is typically too late to make changes. By ignoring potentially helpful contributions from an increasingly knowledgeable public, closed-door technological development has precluded balanced assessments and created acrimony—a dangerously irresponsible and wasteful outcome for both science and society." An appeal to responsible innovation! Another article for the online magazine Gizmodo by George Dvorsky had the misleading title "It's time to declare war on mosquitoes" (7 February). Dvorsky argues that just fighting war against Zika is misguided. Instead Dvorsky uses the metaphor of 'Brazilian Jiu-Jitsu' – i.e. we have to fight clever so to speak and mix effective population control measures 'with the latest that genomic technologies have to offer' – including gene drives. Dvorsky quotes Esvelt as telling Gizmodo: "Gene drive offers a way of altering, reducing, or even eliminating these deadly mosquitoes in the wild by ensuring that genomic changes are preferentially inherited by offspring," .. "CRISPR gene drives capable of affecting the worst offenders are nearly within our reach." However, as Dvorsky says, there are other options too and it's worth reading the whole article to get familiar with some of them. Finally, an article by the risk specialist Andrew Maynard, uses, like Dvorsky's one, a range of war metaphors (arsenal, combat etc.). However, it is one of the rare ones that talk about 'synthetic biology', throws in some synbio metaphors (italicised) and still talks about responsible use of new technologies in a messy context, namely biology: "Yet we still have only the vaguest ideas of how the systems we're hacking actually work. It's as if we've been given free rein to play with life's operating system code, but unlike computers, we don't have the luxury of rebooting when things go wrong. This is not an argument against using synthetic biology to combat Zika and other infectious diseases – far from it. If developed responsibly, the technology could save millions of lives, and improve living conditions for countless more. It does mean, though, that we have to be exceptionally cautious in how we proceed – and take every ounce of advice and insight we can get on how to weigh the potential risks and consequences of what we do. " Although the word gene drive as such doesn't evoke war and combat, in the context of Zika it began to attract such connotations, as there was ample talk about driving down the insect population, driving it out, as well as of course driving genetic modification through a whole population. There is also talk about eradication, extinction and, of course, control. Sending in GM insects and deploying gene drives as the ultimate weapon in the war against Zika is, as one article pointed out, part of a 'macho' solution, a solution that focuses on a technofix focused on killing the insects/virus. This militaristic, command and control, frame sidelines a number of issues which are discussed in a few articles, such as responsibility, transparency and public scrutiny. More importantly though, looking at Zika through a militaristic lens, blends out a whole lot of social, political and ethical issues related to poverty, inequality and gender. This has implications for social, public and health policy, but also for health, risk and science communication. Communication within a command and control context is very different to communication within an engaged community context. Military metaphors are commonplace in medicine and 'explode' in particular during epidemics or pandemics like AIDS, foot and mouth disease, SARS, and most recently Ebola. As Cooter pointed out many years ago in a chapter on 'War and modern medicine' (1994), "each of our 'illnesses' must be fought (usually with the help of magic bullets, which we sometimes receive in the form of shots); that we battle AIDS by seeking the means to restore defence systems), is but small testimony to the profundity and reach of the process. 'Biomilitarism', as one discourse analyst has labelled it, is now the language of modern biomedicine." Modern advances in biotechnology and biomedicine, including gene editing and gene drives, still get caught up in this archaic but persistent, pervasive militaristic framing, a framing that has ethical, social and political consequences for those living with Zika. We have to be careful. If you frame a disaster, crisis or epidemic like a war, it gradually becomes a war; with winners (probably Oxitec/Intrexon) and with losers, victims, casualties and collateral damage (probably women and children). Although martial in tone, the 'Brazilian Jiu-Jitsu' metaphor was actually an effective means of highlighting the need for a balanced approach. As the case of gene drives demonstrate, the metaphors we use in synthetic biology can have wide-ranging impacts on society, and this will only be amplified as scientists seek to take the tools they have developed into the world. Explore further: Video: Zika, mosquitoes and how to not get bitten
News Article | March 14, 2016
An Aedes aegypti mosquitoe is seen at the Laboratory of Entomology and Ecology of the Dengue Branch of the U.S. Centers for Disease Control and Prevention in San Juan, March 6, 2016. REUTERS/Alvin Baez More REUTERS - U.S. health regulators said a genetically engineered mosquito being used in the fight against Zika will not have a significant impact on the environment, possibly paving the way for the technique to be used in the country. The self-limiting strain of the Aedes aegypti mosquito was developed by Oxitec, the U.K.-subsidiary of U.S. synthetic biology company Intrexon Corp. The male mosquitoes are modified so their offspring will die before reaching adulthood and being able to reproduce. The FDA agreed with an environmental assessment submitted by Oxitec, saying preliminary findings suggested that the genetically modified mosquitoes will not have a significant impact on the environment. Oxitec is proposing to conduct an investigational trial, designed to evaluate the effectiveness of its mosquitoes, in the Florida Keys region. The findings come on the heels of rising concern over Zika virus in the United States, with Florida declaring a public health emergency last month. Zika virus, first detected in Africa in the 1940s, was unknown in the Americas until last year when it appeared in northeastern Brazil, where it has been linked to a spike in birth defects in thousands of babies. Florida's warm climate and nearly year-round mosquito season make it particularly vulnerable to spreading, although so far all of the state's cases were acquired abroad, officials have said. "If we do get permission from the FDA to go ahead, we are hoping that we will start running the program sometime in 2016," Oxitec Chief Executive Hadyn Parry said on a media call on Friday. Oxitec, which was spun off from Oxford University, was acquired last year by Intrexon. Efficacy trials in Brazil, Panama, and the Cayman Islands showed that this approach has helped reduce the Aedes aegypti population by more than 90 percent, Oxitec said. Parry added that until now mosquito control techniques in the United States have only been able to reduce population by about 50 percent. However, the concept of wiping out an entire mosquito species also raises ecological questions, as it runs counter to preserving biodiversity. A petition on Change.org by Mila de Mier, a Key West resident, has gathered more than 161,000 supporters, and calls for the FDA to not approve the genetically modified mosquitoes . The public can submit comments on the conclusion for the next 30 days, starting Monday. (http://1.usa.gov/229sDd2) Intrexon's shares closed up 8.5 percent at $37.97 on the New York Stock Exchange on Friday.
News Article | December 19, 2016
John Maslowski Succeeds David Pernock as Chief Executive Officer; Douglas Swirsky Appointed Chairman of the Board of Directors EXTON, Pa., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc. (NASDAQ:FCSC) today announced that John Maslowski has been appointed Chief Executive Officer (CEO) and Douglas Swirsky has been appointed Chairman of the Company’s Board of Directors, succeeding David Pernock effective immediately. In addition, Mr. Maslowski has been appointed to the Company’s Board. “During 2016, Fibrocell has completely transitioned to a clinical-stage gene therapy company and we are confident that under John’s leadership its significant momentum will continue. We look forward to fulfilling the promise of our proprietary fibroblast platform for patients suffering from rare, devastating genetic diseases of the skin and connective tissue,” said Mr. Swirsky. “We appreciate David’s contributions to Fibrocell and wish him well as he pursues new business opportunities.” Mr. Maslowski joined Fibrocell in 2005 and most recently served as the Company’s Senior Vice President of Scientific Affairs with oversight of research and development, clinical and regulatory affairs. Previously, he was Vice President of Operations with responsibility for manufacturing and quality operations. Prior to joining Fibrocell, he held various positions at Wyeth Pharmaceuticals, Inc., Merck & Co., Inc. and Teva Pharmaceutical Industries Ltd. Mr. Maslowski earned a B.S. in Biology from Ursinus College and an M.S. in Biology from Villanova University. “I am honored to be appointed CEO of Fibrocell and have the opportunity to lead our dedicated team as we move into 2017 and beyond,” said Mr. Maslowski. “Our pipeline consists of therapies with transformative potential that target the underlying cause of disease and I look forward to working with our team, Doug and the Board as we advance FCX-007, our clinical-stage candidate for the treatment of recessive dystrophic epidermolysis bullosa, and our other cell-based gene therapy programs.” FCX-007 is Fibrocell's clinical-stage, gene-therapy product candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a congenital and progressive orphan skin disease caused by the deficiency of the protein type VII collagen (COL7). FCX-007 is a genetically-modified autologous fibroblast that encodes the gene for COL7 and is being developed in collaboration with Intrexon Corporation (Intrexon). By genetically modifying autologous fibroblasts ex vivo to produce COL7, culturing them and then treating wounds locally via injection, FCX-007 offers the potential to address the underlying cause of the disease by providing high levels of COL7 directly to the affected areas while avoiding systemic distribution. To learn more about the FCX-007 Phase I/II clinical trial, please visit www.clinicaltrials.gov and search the identifier NCT02810951. FCX-013 is Fibrocell’s gene-therapy product candidate for the treatment of linear scleroderma, a chronic autoimmune disease characterized by thickening of the skin and connective tissue that can be debilitating and painful. FCX-013 is an autologous fibroblast cell genetically modified to express a protein to breakdown excess type I collagen and type III collagen at the site of the localized disease and is also being developed in collaboration with Intrexon. FCX-013 incorporates Intrexon’s proprietary RheoSwitch Therapeutic System®, a biologic switch activated by an orally administered compound which allows control of future protein expression once the initial fibrosis has been resolved. FCX-013 is currently in pre-clinical development for the treatment of linear scleroderma, a form of localized scleroderma. Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue. Fibrocell’s most advanced product candidate, FCX-007, has begun a Phase I/II trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its product candidate for the treatment of linear scleroderma. In addition, Fibrocell has a third program in the research phase for the treatment of arthritis and related conditions. Fibrocell’s gene-therapy portfolio is being developed in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology. For more information, visit www.fibrocell.com or follow us on Twitter at @Fibrocell. Fibrocell, the Fibrocell logo, Fibrocell Science and LAVIV® are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners. Forward-Looking Statements This press release contains, and our officers and representatives may from time to time make, statements that are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential advantages of FCX-007 and Fibrocell’s other product candidates; Fibrocell’s expectation to dose the first subject in the Phase I portion of its FCX-007 trial at the end of the year; and other statements regarding Fibrocell’s future operations, financial performance and financial position, prospects, strategies, objectives and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated herein including, among others: whether pre-clinical and clinical trial results will validate and support the safety and efficacy of Fibrocell’s product candidates; and the risks, uncertainties and other factors discussed under the caption “Item 1A. Risk Factors” in Fibrocell’s most recent Form 10-K filing and Form 10-Q filings. As a result, you are cautioned not to place undue reliance on any forward-looking statements. While Fibrocell may update certain forward-looking statements from time to time, Fibrocell specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise.
News Article | December 2, 2016
United States, EU, Japan, China, India and Southeast Asia Diagnosis and Treatment of Zika Virus Disease Market This report studies the Global Diagnosis and Treatment of Zika Virus Disease Market, analyzes and researches the Diagnosis and Treatment of Zika Virus Disease development status and forecast in United States, EU, Japan, China, India and Southeast Asia. This report focuses on the top players in global market, like Bharat Biotech Inovio Pharmaceuticals and GeneOne Life Sciences Intrexon Cerus Sanofi NewLink Genetics Immunovaccine GlaxoSmithKline ATCC ZeptoMetrix Market segment by Application, Diagnosis and Treatment of Zika Virus Disease can be split into Application 1 Application 2 Application 3 United States, EU, Japan, China, India and Southeast Asia Diagnosis and Treatment of Zika Virus Disease Market Size, Status and Forecast 2021 1 Industry Overview of Diagnosis and Treatment of Zika Virus Disease 1.1 Diagnosis and Treatment of Zika Virus Disease Market Overview 1.1.1 Diagnosis and Treatment of Zika Virus Disease Product Scope 1.1.2 Market Status and Outlook 1.2 Global Diagnosis and Treatment of Zika Virus Disease Market Size and Analysis by Regions 1.2.1 United States 1.2.2 EU 1.2.3 Japan 1.2.4 China 1.2.5 India 1.2.6 Southeast Asia 1.3 Diagnosis and Treatment of Zika Virus Disease Market by End Users/Application 1.3.1 Application 1 1.3.2 Application 2 1.3.3 Application 3 2 Global Diagnosis and Treatment of Zika Virus Disease Competition Analysis by Players 2.1 Diagnosis and Treatment of Zika Virus Disease Market Size (Value) by Players (2015-2016) 2.2 Competitive Status and Trend 2.2.1 Market Concentration Rate 2.2.2 Product/Service Differences 2.2.3 New Entrants 2.2.4 The Technology Trends in Future 3 Company (Top Players) Profiles 3.1 Bharat Biotech 3.1.1 Company Profile 3.1.2 Main Business/Business Overview 3.1.3 Products, Services and Solutions 3.1.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.1.5 Recent Developments 3.2 Inovio Pharmaceuticals and GeneOne Life Sciences 3.2.1 Company Profile 3.2.2 Main Business/Business Overview 3.2.3 Products, Services and Solutions 3.2.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.2.5 Recent Developments 3.3 Intrexon 3.3.1 Company Profile 3.3.2 Main Business/Business Overview 3.3.3 Products, Services and Solutions 3.3.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.3.5 Recent Developments 3.4 Cerus 3.4.1 Company Profile 3.4.2 Main Business/Business Overview 3.4.3 Products, Services and Solutions 3.4.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.4.5 Recent Developments 3.5 Sanofi 3.5.1 Company Profile 3.5.2 Main Business/Business Overview 3.5.3 Products, Services and Solutions 3.5.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.5.5 Recent Developments 3.6 NewLink Genetics 3.6.1 Company Profile 3.6.2 Main Business/Business Overview 3.6.3 Products, Services and Solutions 3.6.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.6.5 Recent Developments 3.7 Immunovaccine 3.7.1 Company Profile 3.7.2 Main Business/Business Overview 3.7.3 Products, Services and Solutions 3.7.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.7.5 Recent Developments 3.8 GlaxoSmithKline 3.8.1 Company Profile 3.8.2 Main Business/Business Overview 3.8.3 Products, Services and Solutions 3.8.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.8.5 Recent Developments 3.9 ATCC 3.9.1 Company Profile 3.9.2 Main Business/Business Overview 3.9.3 Products, Services and Solutions 3.9.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.9.5 Recent Developments 3.10 ZeptoMetrix 3.10.1 Company Profile 3.10.2 Main Business/Business Overview 3.10.3 Products, Services and Solutions 3.10.4 Diagnosis and Treatment of Zika Virus Disease Revenue (Value) (2011-2016) 3.10.5 Recent Developments For more information or any query mail at [email protected]
News Article | December 12, 2016
Oxitec announced today that after a series of successful contained environment studies across multiple countries with its self-limiting Mediterranean fruit fly (Medfly), the Company is ready to move forward towards open field trials. The studies demonstrated the self-limiting Medfly's ability to successfully mate with wild Medfly and subsequently suppress the pest population. The efficacy of the Oxitec Medfly and existing control methods were also examined. Oxitec's Chief Scientific Officer, Simon Warner, Ph.D., said, "Over the past few years, the performance of our Medfly solution in testing across different countries has confirmed our belief that this product may deliver superior efficacy and an improved environmental profile as compared to many products on the market today. We are now planning to advance our environmentally-friendly Medfly product into field trials in different countries to demonstrate its potential in open environments." The Medfly (Ceratitis capitata) is considered one of the world's most destructive agricultural pests capable of causing billions of dollars in damage by attacking more than 250 types of fruits, nuts and vegetables. Females lay their eggs inside fruit making them vulnerable to infection and rot, and larvae feed on the fruit reducing crop yields and quality. It is found throughout the Mediterranean and Africa, and is an invasive pest in Australia and the Americas. Medfly is difficult to manage by conventional methods because of its ability to infest many types of crops year-round, and growers need alternative technologies for control. Oxitec's approach uses genetically engineered self-limiting Medfly males that are released to mate with wild females. Their female offspring do not survive to adulthood and repeated releases result in a reduction of the pest population. In the latest study, the Western Australia Department of Agriculture and Food (DAFWA) compared the mating performance of Oxitec's Medfly with that of sterile insects treated with radiation, another technique used to control the pest population, to examine whether Oxitec's solution offered an improved option for industry to control Medfly. As reported by DAFWA the mating performance of Oxitec's Medfly "was comparable with that of sterile males irradiated at low levels, and exceeded that of sterile males treated with a higher dose of radiation which is used to provide a better guarantee of sterility." In 2010, Oxitec conducted the first study to demonstrate the efficacy of the self-limiting Medfly in collaboration with the University of Crete, Greece. In the trial, the Medfly pest population was eliminated in glasshouses in 12 weeks. These results were then confirmed in netted trials in Morocco in collaboration with the leading agricultural group in the country, SAOAS. Oxitec's Medfly showed equivalent mating performance with the wild Moroccan Medfly and again successfully suppressed the wild population. Furthermore, excellent control was also shown when the self-limiting Medfly insects were released at different life stages, which would provide growers with a more flexible application regimen than only releasing adult male flies. Trials in Morocco also compared the protection of fruit crops provided by Oxitec's Medfly with that of a leading insecticide used to combat Medfly globally. Sustained releases of Oxitec males resulted in a superior marketable yield of fruit compared to treatment with the leading insecticide. The data showed that Oxitec's solution has the potential to be more cost-effective for the same level of control provided by insecticides and mass trapping. The trial results also demonstrated the potential for combining control practices in an integrated pest management programme in order to provide flexibility to growers. "Advancing to open field trials is an important milestone for our pipeline of self-limiting insect products addressing pest damage to high value fruit and vegetable crops. Studies indicate that annual losses of crops due to these pests, including Mediterranean fruit fly, can reach billions of dollars. Additionally, these difficult to control insects can cause devastating impacts to agricultural economies dependent on high-value produce export," noted Sekhar Boddupalli, Ph.D., President of Intrexon Crop Protection and Head of Intrexon's AgBio Division. Oxitec is a pioneer in using genetic engineering to control insect pests that spread disease and damage crops, and was founded in 2002 as a spinout from Oxford University (UK). Oxitec is a subsidiary of Intrexon Corporation (NYSE: XON), which engineers biology to help solve some of the world's biggest problems. Follow us on Twitter at @Oxitec.
News Article | March 16, 2016
Debra Fiakas is the Managing Director of , an alternative research resource on small capitalization companies in selected industries. This week Darling Ingredients DAR : NYSE) reported financial results for the quarter ending December 2015, demonstrating management’s collective ability to manage margins in a period of low inflation. The fourth quarter 2015 top-line was $809.7 million, providing $84.4 million in net income or $0.52 per share. Revenue was 19.1% lower than the same period last year, but net income increased by 20.7% year-over-year. Weak commodity prices led to lower sales volumes and selling prices that translated into lower year-over-year revenue. At the same time the commodity market compression also reduced raw materials costs, increasing profit margins.The Company also benefited from its investment in the Diamond Green Diesel joint venture with Valero (VLO: NYSE), by capturing value in the fats supply chain that might have otherwise been lost to Darling as an animal fats recycler. The joint venture is part of Darling fuel ingredients segments, which delivered 8.1% of total sales to the mix in the fourth quarter and an exceptional 37.9% of operating income.Earnings in the December quarter far outpaced expectations for a two-bit bottom line. It was the first upside surprise delivered by the Company in over a year. Consequently, under higher than average trading volume, the stock gapped higher in the first day of trading following the earnings announcement and conference call. The stock gapped higher again in the final day of trading last week, moving well above a line of price resistance that we believed was developed through historic trading volumes at the $11.50 price level.Yet exceptional profit is not the only thing sparking investor interest in Darling Ingredients. Last week Darling announced a new joint venture with Intrexon Corporation (XON: NYSE) to develop black soldier flies for fish and poultry feed. Concurrently, Intrexon acquired EnviroFlight LLC and its proprietary fly husbandry processes as part of the effort to cultivate black soldier fly larvae for fish and poultry feed. The product is expected to be highly marketable given the merits of larvae over wild fish or other protein by-products for these markets. Successful introduction of fly larvae as a preferred feed is also expected to reduce threats to fishing waters from over-fishing and pollution.There were numerous questions during the earnings conference call about the joint venture and the apparent expansion of interest on the part of Darling to expand beyond feed by-product recycling to new feed production. Randall Stuewe related the Darling’s history of work with EnviroFlight as a development partner with the fledgling protein producer. The relationship has been formalized into a joint venture with EnviroFlight’s new owner, Intrexon.Stuewe stated clearly that population growth is outpacing the ability of pastures and fields to produce enough animal feed protein. In particular new sustainable sources of protein are needed for poultry and aquaculture to reduce pressures on other feed sources. Darling has committed approximately $3 million in capital to building a pilot plant for cultivation of black soldier fly larvae. Although a site has not yet been determined, construction could still begin in 2016. Ultimately, each production facility could cost between $4 million to $5 million, with additional capital required to begin operation.The black fly project adds a new dimension to Darling Ingredients business model, which has to this point been largely as a recycler of food by-products not as a cultivator of original feed. Darling Ingredient’s management culture has proven that it is able to handle a wide range of business challenges from tough pricing environments, to large, multi-faceted acquisitions and joint ventures. There is plenty of reason to have confidence in Darling’s soldiers. Neither the author of the Small Cap Strategist web log, Crystal Equity Research nor its affiliates have a beneficial interest in the companies mentioned herein. Crystal Equity Research has a Buy rating on DAR and Darling Ingredients is included in the Biofuel Group of the Beach Boys Index of alternative energy developers and producers.
News Article | January 20, 2016
By Anthony Boadle BRASILIA (Reuters) - A genetically modified mosquito has helped reduce the proliferation of mosquitoes spreading Zika and other dangerous viruses in Brazil, its developers said on Tuesday. The self-limiting strain of the Aedes aegypti mosquito was developed by Oxitec, the U.K.-subsidiary of U.S. synthetic biology company Intrexon. Oxitec, which produces the mosquitoes in Campinas, announced it will build a second facility in nearby Piracicaba, Sao Paulo state, following strong results there in controlling the population of the Aedes vector that also carries the dengue virus.
News Article | November 11, 2016
GERMANTOWN, Md., Nov. 11, 2016 /PRNewswire/ -- Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, today announced that Geno Germano, President of Intrexon, will present at the Stifel 2016...
News Article | February 16, 2017
Randal Kirk, Intrexon CEO chairman & CEO, discusses the biotech company's advances in genetic engineering.