Lilly/Arxxant, RegeneRx/Tß4/Wound Healing, Argus II Retinal Prosthesis System


FDA rejects appeal; Lilly could shelve eye drug

The Food and Drug Administration has denied Lilly's appeal of a ruling demanding more tests to prove whether the drug, Arxxant, is effective in treating eye disease in diabetics. The Indianapolis-based drug maker on Wednesday confirmed the latest wrinkle, which it had disclosed at an investor conference on Tuesday. The FDA said last year that the drug didn't pass muster and wanted Lilly to conduct a new three-year clinical study, which could cost millions of additional dollars.

Lilly said that would have set the drug back by about five years, given the time needed to enroll patients and analyze the data, and the company had appealed the ruling.
"While we're obviously disappointed with the FDA's decision, we will not pursue this appeal further," sai Lilly spokeswoman Lee Lange. Some observers had held out high hopes for the drug. Investment bank Credit Suisse had projected Arxxant would become a blockbuster, generating $1.1 billion in sales by 2010.

Lilly said it would consider its options, including conducting new trials, seeking a partner to help pay for the additional costs, or terminating the project. Lilly already has spent 10 years developing Arxxant, which works by inhibiting an enzyme that plays a key role in the microvascular damage caused by diabetes. But clinical trials showed little proof of benefit, the FDA said. Lilly also plans to withdraw its application for approval in the European Union, at least temporarily, because it won't have time to submit new data demanded by the European Agency for the Evaluation of Medicinal Products under deadline. Unlike the FDA, however, the European agency isn't asking for a new, expensive clinical trial. Lilly declined to say if it would resubmit Arxxant for approval in Europe in the future.


Regulation of MMP-1 Provides New Evidence in Support of Tß4’s Ophthalmic Wound Healing Activities

RegeneRx Biopharmaceuticals, Inc. reported that researchers at the Wayne State University School of Medicine and the Kresge Eye Institute in Detroit, Michigan, found that thymosin beta 4 (Tß4) increases MMP-1 levels in the cornea. MMPs, especially MMP-1, have an important role in the wound healing process as they are involved in cell motility (the movement of new cells to the wound site) and are an integral part of the complex wound healing cascade. Conversely, it has been shown that blocking MMPs inhibits the wound healing process.

The authors included Gabriel Sosne, M.D., Assistant Professor of Ophthalmology and Anatomy/Cell Biology at the Kresge Eye Institute, of the Wayne State University School of Medicine, Detroit, MI; Ping Qiu, Department of Ophthalmology, the Kresge Eye Institute, Detroit, MI; and Michelle Wheater, Department of Biological Sciences, University of Detroit Mercy School of Dentistry, Detroit, MI, published their latest findings in the Journal of Cellular Physiology, Online Edition, March 8, 2007. Dr. Sosne is a member of RegeneRx’s Medical and Scientific Advisory Board.

“Our discovery in the cornea extends the previous studies in the skin by Dr. Hynda Kleinman’s laboratory and further supports our scientific basis for using Tß4 clinically to treat corneal wound healing disorders. Tß4’s ability to rapidly increase levels of MMPs correlates with how it accelerates wound healing in the cornea. Additionally, the ability to understand and regulate these molecules enables us to target the most appropriate clinical applications for novel agents such as Tß4,” according to Dr. Sosne.

http://www.regenerx.com/wt/home/index


FDA Approves Study Of Next-Generation Retinal Implant

The Food and Drug Administration has approved clinical trials of the Argus II Retinal Prosthesis System, which is the next phase of a collaboration between the University of Southern California Doheny Eye Institute, Second Sight Medical Products, and the Department of Energy. Diseases like RP and AMD attack the retina's photoreceptor cells, which then degenerate and fail to capture and process light. The technology comprises a camera and microprocessor mounted in eyeglasses, a receiver implanted behind the ear, and an electrode-studded array that's attached to the retina. The array takes the place of the damaged photoreceptors.

The camera sends images to the microprocessor, which transmits a signal to the receiver. Using a tiny cable, the receiver sends the signal to the array, which then emits pulses that travel along the optic nerve to the brain. The brain perceives patterns of light and dark spots corresponding to the stimulated electrodes. USC and Second Sight tested the first-generation Argus 16, with an array of 16 electrodes, on six patients. All of the patients now can detect light, count discrete items, locate and differentiate objects in their environment, and even perceive motion. The Argus II's 60-electrode array should offer better resolution.

Already, work is under way on a model that will be a fraction the size of the current devices yet include up to 200 electrodes. Such a device must be biocompatible with delicate eye tissue yet able to withstand the eye's corrosive, salty environment. It also must stay attached to the retina without compressing or pulling the tissue. And, it needs to draw enough power to function without generating the kind of heat that would damage what remains of the retina. The DoE has enlisted its member labs to solve these challenges.