Iris Pharma is a French contract research organization (CRO) dedicated to preclinical, or nonclinical, research in ophthalmology. Iris Pharma supplies the necessary understanding to guide new pharmaceutical drugs through the drug development process. Clirophtha is the first worldwide CRO dedicated to ophthalmology and specializing in carrying out Phase I, II, III and IV clinical trials throughout Europe, North Africa, India, and North America.
The combined experience of the two companies totals 31 years, with the staff’s experience representing a combined total of over 260 years.
“The cumulative expertise and experience from both Iris Pharma and Clirophtha guarantees that the new Iris Pharma company has excellent know-how and knowledge of each step of drug development, from preformulation and in vivo research to Phase IV and medico–marketing surveys, as well as a global overview of the whole process,” says Thierry Caillaud, the Business Development Director for the Preclinical Department at Iris Pharma.
Yann Quentric, the Business Development Director of Clirophtha comments, “Our focus is on continuing to provide our customers with the best quality service and the best level of responsiveness. Our expertise and experience in ophthalmology guarantee our customers accurate consulting services at every stage of drug development. We are more than a simple supplier – we act as a dedicated partner in helping our clients to take the right decision, at the right moment, to move forward efficiently and market their drugs faster”.
Iris Pharma is headquartered in France and works in five complimentary areas of bioanalysis: non-GLP preformulation; preclinical studies and services; clinical trials (Phase I–IV); and strategic consulting.
Source: www.iris-pharma.com
American Optometric Association emphasize the importance of early detection for Glaucoma treatment
January was National Glaucoma Awareness month and, according to the American Optometric Association (AOA), people are putting their sight at risk by not receiving regular eye examinations.
“Glaucoma is an eye disease in which the internal pressure in your eyes increases enough to damage nerve fibers in your optic nerve and cause vision loss,” said Dr Tanya Carter, AOA’s Glaucoma Eye Care Expert and State University of New York College of Optometry Professor. “The most common type of glaucoma develops gradually and painlessly, without symptoms. A rarer type occurs rapidly, and its symptoms may include blurred vision, loss of side vision, seeing colored rings around lights, and pain or redness in the eyes.”
The increase in pressure occurs when the passages that normally allow the drainage of the fluid in your eyes become clogged or blocked. Glaucoma begins by attacking peripheral vision, typically causing objects to appear less clearly. These changes may seem minor, but glaucoma can accelerate quickly; causing eyesight to deteriorate rapidly and irreversibly.
Glaucoma is often called “the sneak thief of sight” because it can strike without symptoms. It is one of the leading causes of blindness in the USA and according to the National Eye Institute, more than 3 million Americans have glaucoma but only half of them know it. Glaucoma most often occurs in people over the age of 40 years. People who are very nearsighted, diabetic or have a family history of glaucoma are also at high risk for the disease.
Since vision lost to glaucoma cannot be restored, regular, comprehensive eye examinations are important for people at risk. A comprehensive optometric examination includes a tonometry test to measure pressure in the eyes; an examination of the inside of the eyes and optic nerves; and a visual field test to check for changes in central and side vision.
“Glaucoma cannot be prevented, but if diagnosed and treated early, it can be controlled to prevent or slow continued vision loss,” said Dr. Tanya Carter. “Losing your sight can be devastating, so there is no substitute for doing all you can to maintain your eye health through regular exams.”
Source: www.aoa.org
Pfizer initiates Phase II clinical development of PF-03187207 in Japan
Drug: PF-03187207
Manufacturer: Pfizer Inc.
Researchers: NicOx-Pfizer research team
Patients (n): 120
Indication: Glaucoma
Aims of study: To compare the safety of PFH03187207 against Xalatan® (latanoprost)
The International Glaucoma Association estimates that glaucoma of some type is found in 2% of the population over the age of 40, it can also affect younger adults and children but much less frequently. Although it is thought that over 7 million people across the world suffer from glaucoma, treatment of glaucoma has improved significantly over recent years, with more potent drugs being developed with fewer side effects and greater surgical techniques; this has led to the estimation that approximately 95% of glaucoma sufferers that are diagnosed early in the UK will retain useful sight for life.
PF-03187207 is a new experimental medicine for the treatment of glaucoma, which is currently undergoing a Phase II proof-of-concept study in the USA. Pfizer has recently announced a dose-ranging Phase II clinical study for PF-03187207 in Japan.
Glaucoma is a group of severe eye diseases that gradually lead to blindness but for a long time can go undetected. This study will compare the safety and efficacy of PF-03187207 to Xalatan® (latanoprost) in Japanese patients.
Glaucoma is a group of disorders that are characterized by damage to the optic nerve, which is linked to abnormally high intra-ocular pressure caused by a blockage in the eye’s drainage system. There are two main types of glaucoma; open-angle glaucoma, where there is no physical obstruction of the drainage angle of they eye, and closed-angle glaucoma, which is caused by the iris blocking the drainage of the eye through the trabecular meshwork.
Xalatan is a proprietary Pfizer product and is the number one prescribed eye pressure-lowering medicine for people with high eye pressure or glaucoma. PF-03187207 is the lead development compound generated under the August 2004 collaboration agreement between Pfizer and NicOx’, which focuses on the research and development of nitric oxide-donating prostaglandin F2-α analogs for the treatment of glaucoma.
The joint NicOx–Pfizer research team has been focusing its work on several separate projects, which have involved identifying and testing different classes of nitric oxide-donating compounds that could become treatments for major ocular diseases. The two companies have also recently announced an extension of the collaboration agreement, which grants Pfizer Inc. the exclusive right to apply its proprietary nitric oxide-donating technology to drug discovery research in the field of ophthalmology. Ennio Ongini, Vice “We believe Pfizer’s decision to renew this agreement demonstrates its confidence in the joint research team and the potential of NicOx’ technology to yield new drug candidates for eye disorders. Considerable progress has been made in the research programs and we are expecting that the collaboration will generate a future candidate for development in a major ocular condition.” This 1-year extension of the research phase of the agreement will result in NicOx receiving US$3 million in research funding in March 2008 and prolongs Pfizer’s option to license resulting compounds until May 2009.
Maarten Beekman, Vice President of Clinical Development at NicOx said, “We believe the initiation of this separate Japanese study for PF-03187207 highlights Pfizer’s determination to rapidly advance this clinical program towards coordinated regulatory filing in the world’s major pharmaceutical markets. Preclinical results have suggested that NicOx technology has the potential to deliver improved treatments for glaucoma and we look forward to the results of the ongoing proof-of-concept Phase II study for PF-03187207 in the United States.”
The first clinical study for PF-03187207, initiated in March 2007 in the USA, is a Phase II proof-of-concept study that aims to compare the safety and efficacy of PF-03187207 to Xalatan in terms of lowering intraocular pressure.
The Japanese trial is a 28-day, double-masked, dose-ranging study which will investigate the dose–response, safety and efficacy of PF-03187207 compared to Xalatan in approximately 120 patients with primary open-angle glaucoma or ocular hypertension.
The new Phase II trial is similar in design to the US study, except that it will be conducted in Japan, initiating the program for registration there.
Sources: www.nicox.com; www.glaucoma-association.com
More than one species of bacteria puts more people at risk of trachoma
Trachoma is one of the most common causes of blindness in the developing world; 6 million people are blind because of this disease and many more are actively infected.
Chlamydia trachomatis is the bacterium that remains the leading cause of sexually transmitted bacterial diseases and preventable blindness worldwide. Chronic ocular infections are referred to as trachoma and predominate in developing countries. Since 2001, the WHO has promoted control strategies including antibiotics, improved hygiene and environmental measures with limited success. Consequently, a vaccine is urgently needed but researchers from the Children’s Hospital Oakland Research Institute and the University of California San Francisco have recently found that there are other species of bacteria are also implicated in the development of Trachoma.
C. trachomatis, some strains of which are associated with sexually transmitted infections, can also pass between people on hands and clothing; successive infections cause scarring of the cornea, eventually leading to blindness.
The group randomly selected and tested nine out of 49 households in a trachoma–endemic region of Nepal and found that as well as C. trachomatis, Chlamydophila psittaci and Chlamydophila pneumonia were also present in some subjects, which have previously been associated with lung infections. All three types of bacteria were detected in eight (89%) study households; one household had no members infected with C. pneumoniae. Of 80 infected individuals, 28 had infection with C. psittaci, C. pneumoniae or both. Single and dual infections with C. psittaci and C. pneumoniae were significantly associated with severe conjunctival inflammation, as were single infections with C. trachomatis.
Interventions by the WHO to prevent trachoma, such as the SAFE initiative to improve personal hygiene, have had limited success. The findings of this study, published in PLoS Medicine, show that C. psittaci and C. pneumonia, as well as C. trachomatis, are involved in trachoma and that their distribution is widespread. These results also indicate that the antibiotics used to treat trachoma may need to be changed or used for longer periods to be effective against all strains. The possibility that multiple strains of the Chlamydiceae family of bacteria are involved in trachoma means too, that to a re-evaluation of potential vaccines is necessary to combat this illness.
Source: Dean D, Kandel RP, Adhikari HK, Hessel T. Multiple Chlamydiaceae species in trachoma: implications for disease pathogenesis and control. PLoS Med. 5(1), e14 (2008).
Vision restoration in the progeny of blind cave fish
Richard Borowsky, of the Cave Biology Research Group at the New York University Department of Biology, studies the evolution and genetics of cave fish, with an emphasis on understanding the molecular and developmental bases of adaptation and the ‘eyeless’ condition.
In a study published in Current Biology, Professor Borowsky explains that hybrids of blind cavefish from different cave populations can restore the vision of their offspring.
The study examined four populations of blind cave fish, Astyanax mexicanus, which inhabit different caves in NorthEast Mexico. These fish have evolved from eyed, surface-dwelling forms which only reached the area in the mid-Pleistocene. Genetic analysis showed that the evolutionary impairment of eye development, as well as the loss of pigmentation and other cave-related changes, resulted from mutations at multiple gene sites, means that different sets of genes are nonfunctional in the different populations, thus leading to the theory that the loss of one functional gene in one population may be compensated for by a functional copy in another population. Hybrids between blind cavefish from different caves have larger and better-developed eye rudiments than their parents, reflecting these independent origins and complementation.
“Given the large number of mutations at different loci that have accumulated in these populations, we reasoned that hybridization among independently evolved populations might restore visual function,” Borowsky said. He continued “…the genes that are mutated in one population that lead to blindness are different in other, independently evolved populations. Thus, when you cross them, the genetic deficiencies in one lineage are compensated for by strengths in the other, and vice-versa.”
Hybrids between blind cavefish from different caves have larger and better developed eye rudiments than their parents, reflecting these independent origins and complementation. This study demonstrates restoration of vision in cavefish whose immediate ancestors were blind and whose separate lineages may not have been exposed to light for the last 1 million years.
They also found that the further apart the caves of the cavefish parents were, the more likely it was for their offspring’s vision to be restored, consistent with the idea that populations separated by greater distances are more distantly related and therefore have less overlap in the genes responsible for their blindness.
Sources: Borowsky R. Restoring sight in blind cavefish. Curr. Biol. 18, R23–R24 (2008); www.nyu.edu
Safety and effectiveness tests for a synthetic anti-inflammatory for macular degeneration
Compound: POT-4 – a derivative of the cyclic peptide Compstatin
Indication: Macular degeneration
Center: University of Florida (USA)
Patients (n): 12
A group of researchers from the University of Florida (USA) have performed a first-of-its-kind study to investigate the effects of a synthetic peptide when injected into the eye of patients with macular degeneration.
Macular degeneration affects approximately 9 million Americans, according to the National Eye Institute. Approximately 85% of patients have the less severe dry form, which leads to a gradual and rarely complete vision loss, but the remaining 15% of patients have the severe wet form that causes rapid and disabling blindness.
Wet macular degeneration is also characterized by choroidal neovascularization, where there is an abnormal growth of blood vessels from the choroids which can leak into the retinal tissue. There are drugs available to treat the abnormal growth of blood vessels and therefore alleviate the bleeding that occurs in wet macular degeneration and treat the symptoms, however, until recently, the underlying mechanisms of both forms of the disease were unknown and therefore there was no way to treat the actual cause of the disease.
Almost 3 years ago a series of reports revealed a link between the chronic inflammation and tissue damage that occurs in both forms of macular degeneration, and a defect in the complement system, which is responsible for stimulating an inflammatory response.
“Complement is a set of proteins that are often triggered in inflammatory diseases, including the eye in particular,” said Shalesh Kaushal, MD, PhD, an Assistant Professor of Ophthalmology and Director of the Vitreoretinal Service in the UF Department of Ophthalmology. "There are now multiple reports that these complement proteins may be overstimulated in wet macular degeneration.”
Researchers from Potentia Pharmaceuticals Inc. therefore set out to develop an existing family of complement inhibitors called Compstatin for use in the human eye. In animal studies, complement inhibitors have been shown to prevent the inappropriate inflammatory response that accompanies both the wet and dry forms of macular degeneration.
POT-4 is a derivative of the cyclic peptide Compstatin, which was discovered by Professor John Lambris at the University of Pennsylvania. It binds tightly to the complement component C3 and effectively shuts down all downstream complement activation that could lead to local inflammation and tissue damage. “Compstatin is a unique complement inhibitor,” said Professor Lambris, “POT-4 is a much more active version of the original compound.”
The safety trial at the University of Florida has been funded by Potentia, who designed the anti-inflammatory compound. Teams in Florida, New Hampshire, Minnesota and Arizona are evaluating the safety of POT-4 in humans with the wet form of macular degeneration.
The University of Florida team is continuing to monitor the subjects closely to gather important information about the safety profile of POT-4. After a safety committee reviews data from the first round of participants, an additional 12 subjects will participate in the study.
Sources: www.potentiapharma.com, www.ufl.edu