FOX Translator
No data currently available.
No data currently available.
Welcome to the major leagues of debt. Collateralized debt obligations, almost always referred to as a CDOs, are horrendously
complicated deals that often leave anyone without a MBA wondering what was put into these CDOs.
The first thing to
understand about bonds, (aka debt) is that bonds are often backed by something else. Think about your home mortgage. If you
don't pay your mortgage, the bank can take the house. You end up homeless, and the bank sells the house to pay off the rest
of that mortgage. There is something "backing" that mortgage; something lender can fall back on, if you don't pay your bills
like a good human being. That's called collateral.
CDOs are one flavor of an entire sector of investing called structured
finance, and they are also backed. CDOs, in the simplest concept, are just bonds backed by something else. In most cases,
a CDO is backed by a collection of various types of debt. CDOs can be home mortgages, or other types of debt like credit cards,
auto loans, and personal loans. Most of these types of debt are usually considered a bit more risky and they don't have the
backing that a home loan does. So, if you think it through, you can imagine that CDOs are usually considered a risky investment.
To take a step further, understand that CDOs have multiple flavors within each CDO. These flavors are called tranches. If you've taken French, you might recognize the word, it means "slice" or "portion." Each slice of that CDO you invest in is a little different and carries different amounts of risk.
You could invest in the lowest risk tranche of the CDO, which would
provide you lower risk. But, you don't get a good return on that investment. Or, you can be the heroic adventurer of bonds
and invest in the lowest-grade tranche of the CDO. You'll make an amazing return, but if the economy even looks at you wrong,
you might lose the entire investment.
CDOs aren¿t easy, and are almost always invested in by mutual funds, insurance
companies and hedge funds. As an individual investor, you will probably not come across a CDO you can participate in.
Home
Thursday, June 26, 2008
Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
Comtex
ATLANTA, June 26, 2008 /PRNewswire via COMTEX/ ----Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported the interim month three safety and efficacy results from the first human pharmacokinetic (PK) study of Medidur(TM) FA, which Alimera Sciences intends to market under the tradename Iluvien(TM), if approved by the U.S. Food and Drug Administration.
This 36-month, open-label Phase 2 study, running concurrently with the pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in diabetic macular edema (DME) patients. Secondarily, the study is designed to provide information on the safety and efficacy of Iluvien in a DME population. A total of 37 subjects were enrolled in this trial, 20 patients on the low dose (an approximate 0.23 microgram per day dose) of Iluvien, and 17 patients on the high dose (an approximate 0.45 microgram per day dose) with the same inclusion/exclusion criteria as the ongoing Phase 3 FAME Study.
Iluvien is an intravitreal insert being developed for the treatment of DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 24 months for the low dose and up to 36 months for the high dose. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
This three-month interim readout from the PK Study indicated 20 percent of the low dose patients and 18 percent of the high dose patients showed an improvement in best-corrected visual acuity (BCVA) of 15 letters or greater from baseline. In addition, both the low dose and the high dose of Iluvien resulted in a significant reduction in retinal thickness as compared to the baseline.
From a safety perspective, no adverse events related to intraocular, or inner eye, pressure were seen in the low dose patients, while 12 percent of the high dose patients experienced intraocular pressure increases of greater than 30 mmHg. Additionally, the only adverse event related to cataract formation was reported in a patient in the high dose group.
The early readout from this PK Study provides further insight into the dose-response of FA in the treatment of DME. By comparison, Bausch & Lomb's Retisert(R) (fluocinolone acetonide intravitreal implant), with an initial release dose of 0.6 microgram per day, was also studied in a DME population. It demonstrated a significant improvement in visual acuity at one year, comparable to the Iluvien results reported here; however, a lower dose was not tested. Therefore, it has not been determined if Retisert's dosage level represents the lowest efficacious dose for DME.
"We believe this early readout from our PK Study supports our premise that lower doses of FA delivered by Iluvien will provide visual acuity improvements while reducing the risk of ocular side effects commonly associated with the use of corticosteroids," said Ken Green, Ph.D., chief scientific officer for Alimera.
Data from this open-label study will be evaluated on an ongoing basis with interim looks at months 3, 6, 12, 18, 24, 30 and 36. Except for the month 12 and final month 36 looks, when the database will be fully locked, interim evaluations will be based on unaudited data. The last patient was enrolled in this study at the end of February 2007.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently the company is focused on diseases affecting the back of the eye, or retina. Its most advanced product candidate is Iluvien(TM), which is being developed for the treatment of diabetic macular edema, or DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Under one protocol, enrollment was completed in October 2007 in two Phase 3 pivotal trials for the use of Iluvien in the treatment of DME conducted across the U.S., Canada, Europe and India, with a combined total enrollment of 956 patients.
Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management -- specifically the reduction of reactive oxygen species (ROS) -- as a treatment strategy for ophthalmic diseases. Under this agreement, Alimera has the exclusive option to license compounds, which are NADPH (nicotinamide adenine dinucleotide phosphate reduced form) oxidase inhibitors, as potential treatments for conditions such as the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy. Alimera retains the right to use the Medidur(TM) delivery system for two of these compounds, and is also exploring other delivery technologies to apply to these compounds.
SOURCE Alimera Sciences, Inc.
Copyright (C) 2008 PR Newswire. All rights reserved
Market Snapshot
| Symbol | Last Price | Netchange | Volume |
|---|---|---|---|
| -- | -- | -- | -- |
| -- | -- | -- | -- |
| -- | -- | -- | -- |
| -- | -- | -- | -- |
| -- | -- | -- | -- |
FOX Business Tools
Sponsored By
