Potentia gets FDA approval to test blindness drug
Potentia Pharmaceuticals has won FDA approval to begin a human clinical trial of what could become the first treatment for age-related macular degeneration, which causes vision loss. The Louisville company said a Phase I trial is expected to begin by the end of this month to determine the safety of its drug, called POT-4.
Several studies published in 2005 showed evidence that a process called complement activation, in which the immune system attacks viruses or bacteria in the body, has a role in causing macular degeneration. POT-4 inhibits that immune-system response. It is the first so-called complement inhibitor approved by the FDA for a human trial, Potentia said. The drug is derived from a compound discovered at the University of Pennsylvania. Potentia obtained rights to develop and market it last year.
Potentia said earlier this month that it had raised $5 million to test the drug. The company has 12 employees and is located downtown in the Louisville Life Science Research Park. The Phase I trial will be held at sites in Florida and Arizona, said Pascal Deschatelets((cq)), chief operating officer of Potentia. It could be followed by larger trials of the drug’s effectiveness, perhaps leading to market approval around 2011, he said. Potentia was formed in 2001 in the Boston area, where its scientists were trained at Harvard, then moved in 2003 to Louisville.
http://www.potentiapharma.com/products/pot4.htm

VEGF and its receptors are expressed in rosacea skin samples, study finds
Vascular endothelial growth factor and its receptors are expressed in skin samples taken from patients with rosacea, a study by researchers in Oregon found.
Using immunostaining, Justine R. Smith, MD, and colleagues at Oregon Health and Science University found VEGF-R1 in 70% and VEGF-R2 in 100% of 20 samples of vascular endothelium. However, the researchers found VEGF itself in only 10% of samples, according to the study. In addition, infiltrating leucocytes, including lymphocytes, macrophages and plasma cells, all expressed VEGF-R1 and VEGF-R2, and 85% expressed VEGF, the authors noted. "Although not expressed by endothelium, VEGF is present in epidermis and epithelium, and is expressed by infiltrating cells," the authors said. "VEGF receptor-ligand binding may contribute to the vascular changes and cellular infiltration that occurs in rosacea."

Scientists explain luteins anti-inflammatory role
Scientists in the US have identified a mechanism that may explain how lutein acts against inflammation, research that deepens understanding of the nutrient's benefits. Lutein,, a nutrient found in various foods including green leafy vegetables and egg yolk, has a ten-year history in the dietary supplement market as a nutrient to reduce the risk of age related macular degeneration (ADM). With eye health as its main spot, the lutein market is currently estimated to be worth in the region of US$100m and $130m.
While a number of studies of studies have reported anti-inflammatory effects for the nutrient, the actual mechanism behind the apparent effects has not been elucidated. Chronic inflammation, brought about by an over-expression or lack of control of the normal protective mechanism, can lead to a range of inflammatory related disease, particularly cardiovascular disease, the leading cause of death in Europe. New research from Mohamed Rafi and Yassaman Shafaie from the State University of New Jersey looked at the effects of lutein using the lipopolysaccharide (LPS)-stimulated mouse macrophage cell line (RAW 264.7)
LPS stimulates the production of nitric oxide (NO), over-expression of NO has been reported to have detrimental effects in the host. Writing in the journal Molecular Nutrition & Food Research, Rafi and Shafaie report that addition of lutein reduced NO production by 50 per cent, compared to the LPS-alone sample. Further study, looking at the expression of inducible NO synthase, the enzyme that produces NO, and found a 1.9-fold reduction in expression of this enzyme at the mRNA level, and a 72.5 per cent reduction in expression of this enzyme at the protein level.
"The results of this study suggest the anti-inflammatory properties of lutein demonstrated by the decrease in the expression of iNOS at the mRNA and protein levels in RAW 264.7 mouse macrophage cells," they concluded. Public awareness of lutein has never been higher in Europe, with a recent survey, from Frost and Sullivan and commissioned by Kemin, finding that awareness has doubled compared to last year, to 25.8 per cent and 16 per cent in Italy and France, respectively. Germans showed the greatest awareness, of 33.3 per cent. The UK was the only country where it seemed to have slipped slightly, to 20 per cent (compared to 25.8 in 2005).
jeudi 22 mars 2007
Zinc/AMD, SUN Pharma/Pipeline, Retina Implant
German Eye Implant Delivers Basic Images to Blind
Initial results from a pilot study show that a chip developed by German scientists is capable of partially restoring basic sight to the blind. Blind subjects were able to see beams of light after scientists implanted an electric microchip in their retina, showing that the chips fundamentally work, according to Eberhart Zrenner, head of Tübingen University's Ophthalmology Research Institute.
Similar to the photoreceptor cells they are intended to replace, the chips collect light information and pass it in the form of electrical impulses along existing optic nerves to the brain, where the information is processed, Zrenner said. Still in the research stage, the therapy is only suitable for people who were once able to see but whose eyes suffer from damaged photoreceptors. The implant is not able to restorve vision to patients with a damaged optical cortex or who were born blind.
Chips intended for basic orientation
The implant is not able to help in all cases of blindness The people who were treated with the implant could recognize light in certain forms and patterns, locate light sources like lights and windows. Some of the patients were also able to locate bright objects, such as cups and plates, on a dark background. Zrenner said the project's next stage involves implanting chips in six other patients' maculas, where photoreceptors are especially dense, to see if better results can be achieved. "The chips did not lay on the spot where vision is the sharpest, but on the periphery, which could have led to their signals from the retina not being optimally processed by the brain," he said.
The project's goal is to develop an implant that would give patients enough sight to orient themselves in new rooms and spaces and recognize large objects. The pilot study intends to determine the implant's safety and the human body's tolerance to accept objects placed inside the eye on the basis of a four-week temporary implantation.

Chips to be ready by 2009
The first chips are expected to be ready for market by 2009, according to Walter Wrobel, head of the Reutlinger Retina Implant, a company that developed out of the research project and created the implant, which is about the size of a grain of rice. It costs 25,000 euros ($33,000). Though they are not expected to be restore perfect vision to the blind, the implants do represent a major technological advance, said Karl Ulrich Bartz-Schmidt, a retinal surgon in Tübingen. "Aviation pioneers did not fly over the Atlantic right away," he said. "You should not expect too much from the technology. It would be a great success if we could eventually give patients back a limited ability to orient themselves."
Several German researchers are also working on similar implant projects for over 10 years, according to Christian Ohrloff, the head of the German Ophthalmology Society.

High Zinc Levels in Eyes Linked to AMD
A U.K. study finds that elevated levels of zinc in the eyes may play a role in the development of age-related macular degeneration (AMD), the leading cause of blindness among elderly people in the developed world, BBC News reported. The study, led by London's Institute of Ophthalmology, found that the eyes of people with AMD have high levels of zinc in drusen, microscopic structures in the eye that are an early sign of AMD.
"Zinc had previously been shown to contribute to the formation of plaques in the brains of patients with Alzheimer's disease, so it was logical for us to test the idea that zinc might also contribute to the formation of plaque-like drusen in the eye as well," said researcher Dr. Imre Lengyel. "AMD can be considered as the Alzheimer's disease of the eye, in that both involve the build-up of proteins and metals like zinc and copper into microscopic clumps," Lengyel said.

Sun Pharma discloses NCE & NDDS pipeline
In a detailed presentation yesterday, management shared details of its NCE and NDDS programs that the team of scientists at its research center, SPARC, have been working on. 4 NCEs and products based on 4 NDDS platform technologies were discussed.Sun Pharma shared information on its therapeutic analogue based programs in the allergy/ inflammation area. Modification of poorly absorbed molecules is another focus area.
SUN 1334 H, a selective histamine receptor antagonist, is currently in Phase II clinical trials in the US. This is an antiallergic used for seasonal and allergic rhinitis, urticaria, etc. In preclinical studies, Sun 1334H was found to have high specificity for H1 receptors, and this indicates a low side effect profile. Sun 1334H was found to have a clean profile with fast onset of action, was non sedating and offered efficacy similar to cetirizine. Phase I trials in Europe indicated that the molecule was well tolerated, effective and appropriate for once-a-day dosing. Phase III for this lead is estimated to begin in 2008.
SUN 461, an anti-inflammatory for asthma and COPD, is being developed as an inhalation drug. This soft corticosteroid is a glucocorticoid receptor agonist, with similar activity but significantly lower side effects whe compared to other marketed steroids.
SUN 44, a prodrug of gabapentin for the treatment of neuropathy and seizures, uses molecular modifications in the structure for better absorption. In preliminary animal studies, this molecule was found to be far better absorbed and safer than existing products. Its profile indicates higher blood availability, a once-a-day formulation and higher safety.
SUN 09 is a prodrug of a currently marketed drug used as a skeletal muscle relexant for spasm related disorders. This molecule’s physicochemical and structural features have been modified for better absorption, and it seems to be easy to formulate as an injectable and once-a-day dosage form. Preclinical and acute toxicity studies on this molecule are ongoing.
SUN 44, 09 and 461 are at preclinical stages. IND filing and Phase I for these projects will begin in 2008.
Delivery system based projects: Four delivery system based platforms and the projects based on these were highlighted.
Dry Power Inhaler (DPI): The novel DPI for asthma and COPD delivers a uniform dose over a range of patient effort and can be used both with existing steroid and bronchodilator combinations, as well as NCE steroid molecules. It can also be modified for systemic delivery of drugs to lungs. This easy to operate inhaler– just 3 steps of open, inhale and close - will comply with US FDA and European regulatory requirements. Our DPI is designed to deliver uniform dose irrespective of patient inhalation effort, eliminate double dosing or dose wastages and ease use by children, adults as well as elderly thus addressing shortcomings of other devices. A product based on this novel DPI is likely to be launched in semi-regulated markets by 2009, and an NDA will be filed for regulated markets by 2011.
Controlled-release drug delivery systems
The Gastro Retentive Innovative Device (GRID) is designed to retain and release a drug over an eight hour span, ideal for an once- a - day system. The release profile can be tailored to give a combination of instant and sustained release profiles.
Baclofen GRS, a once-a-day formulation as compared to twice or thrice daily administration of the competing product, is being developed to treat muscle spasticity. For India, clinical trials have been completed successfully after which the product was approved. For the US, IND filing is likely in 2007.
Wrap matrix: This multi-layered matrix based tablet is designed to offer a controlled release of high dose and high solubility products. This design has an advantage over competing technologies, where it is difficult to reproduce bioavailability. Metoprolol XL with a once-a-day advantage, has been launched in India. A few ANDAs using this technology have been filed with the USFDA.
Tobramycin + Dexa ophthalmic solution: Unlike the competing product which is a suspension causing gritty feeling in the eye, our product is being developed as a clear solution for use in the prophylaxis of infections after cataract surgery. A pre-IND meeting with the FDA has been completed, with likely IND filing for 2007.
Depot Technology that uses long-acting injectable microparticles for slow/sustained drug release over a month to several months using biocompatible and biodegradable polymers. Our product uses a conventional needle, unlike the competing product where tiny rods are implanted, thus reducing patient trauma and pain. A GnRH analogue is in preclinial trials, with clinical studies slated for 2008. A somatostatin analogue is in clinical studies in India.
Nanoemulsion based products that offer higher drug localization to the cancer cells and fewer side effects were discussed. Our product uses an unique encapsulation process to achieve more than 98% encapsulation of bioactive substance, unlike competing products. Two cytotoxic products are being developed with this technology.
Initial results from a pilot study show that a chip developed by German scientists is capable of partially restoring basic sight to the blind. Blind subjects were able to see beams of light after scientists implanted an electric microchip in their retina, showing that the chips fundamentally work, according to Eberhart Zrenner, head of Tübingen University's Ophthalmology Research Institute.
Similar to the photoreceptor cells they are intended to replace, the chips collect light information and pass it in the form of electrical impulses along existing optic nerves to the brain, where the information is processed, Zrenner said. Still in the research stage, the therapy is only suitable for people who were once able to see but whose eyes suffer from damaged photoreceptors. The implant is not able to restorve vision to patients with a damaged optical cortex or who were born blind.
Chips intended for basic orientation
The implant is not able to help in all cases of blindness The people who were treated with the implant could recognize light in certain forms and patterns, locate light sources like lights and windows. Some of the patients were also able to locate bright objects, such as cups and plates, on a dark background. Zrenner said the project's next stage involves implanting chips in six other patients' maculas, where photoreceptors are especially dense, to see if better results can be achieved. "The chips did not lay on the spot where vision is the sharpest, but on the periphery, which could have led to their signals from the retina not being optimally processed by the brain," he said.
The project's goal is to develop an implant that would give patients enough sight to orient themselves in new rooms and spaces and recognize large objects. The pilot study intends to determine the implant's safety and the human body's tolerance to accept objects placed inside the eye on the basis of a four-week temporary implantation.

Chips to be ready by 2009
The first chips are expected to be ready for market by 2009, according to Walter Wrobel, head of the Reutlinger Retina Implant, a company that developed out of the research project and created the implant, which is about the size of a grain of rice. It costs 25,000 euros ($33,000). Though they are not expected to be restore perfect vision to the blind, the implants do represent a major technological advance, said Karl Ulrich Bartz-Schmidt, a retinal surgon in Tübingen. "Aviation pioneers did not fly over the Atlantic right away," he said. "You should not expect too much from the technology. It would be a great success if we could eventually give patients back a limited ability to orient themselves."
Several German researchers are also working on similar implant projects for over 10 years, according to Christian Ohrloff, the head of the German Ophthalmology Society.

High Zinc Levels in Eyes Linked to AMD
A U.K. study finds that elevated levels of zinc in the eyes may play a role in the development of age-related macular degeneration (AMD), the leading cause of blindness among elderly people in the developed world, BBC News reported. The study, led by London's Institute of Ophthalmology, found that the eyes of people with AMD have high levels of zinc in drusen, microscopic structures in the eye that are an early sign of AMD.
"Zinc had previously been shown to contribute to the formation of plaques in the brains of patients with Alzheimer's disease, so it was logical for us to test the idea that zinc might also contribute to the formation of plaque-like drusen in the eye as well," said researcher Dr. Imre Lengyel. "AMD can be considered as the Alzheimer's disease of the eye, in that both involve the build-up of proteins and metals like zinc and copper into microscopic clumps," Lengyel said.

Sun Pharma discloses NCE & NDDS pipeline
In a detailed presentation yesterday, management shared details of its NCE and NDDS programs that the team of scientists at its research center, SPARC, have been working on. 4 NCEs and products based on 4 NDDS platform technologies were discussed.Sun Pharma shared information on its therapeutic analogue based programs in the allergy/ inflammation area. Modification of poorly absorbed molecules is another focus area.
SUN 1334 H, a selective histamine receptor antagonist, is currently in Phase II clinical trials in the US. This is an antiallergic used for seasonal and allergic rhinitis, urticaria, etc. In preclinical studies, Sun 1334H was found to have high specificity for H1 receptors, and this indicates a low side effect profile. Sun 1334H was found to have a clean profile with fast onset of action, was non sedating and offered efficacy similar to cetirizine. Phase I trials in Europe indicated that the molecule was well tolerated, effective and appropriate for once-a-day dosing. Phase III for this lead is estimated to begin in 2008.
SUN 461, an anti-inflammatory for asthma and COPD, is being developed as an inhalation drug. This soft corticosteroid is a glucocorticoid receptor agonist, with similar activity but significantly lower side effects whe compared to other marketed steroids.
SUN 44, a prodrug of gabapentin for the treatment of neuropathy and seizures, uses molecular modifications in the structure for better absorption. In preliminary animal studies, this molecule was found to be far better absorbed and safer than existing products. Its profile indicates higher blood availability, a once-a-day formulation and higher safety.
SUN 09 is a prodrug of a currently marketed drug used as a skeletal muscle relexant for spasm related disorders. This molecule’s physicochemical and structural features have been modified for better absorption, and it seems to be easy to formulate as an injectable and once-a-day dosage form. Preclinical and acute toxicity studies on this molecule are ongoing.
SUN 44, 09 and 461 are at preclinical stages. IND filing and Phase I for these projects will begin in 2008.
Delivery system based projects: Four delivery system based platforms and the projects based on these were highlighted.
Dry Power Inhaler (DPI): The novel DPI for asthma and COPD delivers a uniform dose over a range of patient effort and can be used both with existing steroid and bronchodilator combinations, as well as NCE steroid molecules. It can also be modified for systemic delivery of drugs to lungs. This easy to operate inhaler– just 3 steps of open, inhale and close - will comply with US FDA and European regulatory requirements. Our DPI is designed to deliver uniform dose irrespective of patient inhalation effort, eliminate double dosing or dose wastages and ease use by children, adults as well as elderly thus addressing shortcomings of other devices. A product based on this novel DPI is likely to be launched in semi-regulated markets by 2009, and an NDA will be filed for regulated markets by 2011.
Controlled-release drug delivery systems
The Gastro Retentive Innovative Device (GRID) is designed to retain and release a drug over an eight hour span, ideal for an once- a - day system. The release profile can be tailored to give a combination of instant and sustained release profiles.
Baclofen GRS, a once-a-day formulation as compared to twice or thrice daily administration of the competing product, is being developed to treat muscle spasticity. For India, clinical trials have been completed successfully after which the product was approved. For the US, IND filing is likely in 2007.
Wrap matrix: This multi-layered matrix based tablet is designed to offer a controlled release of high dose and high solubility products. This design has an advantage over competing technologies, where it is difficult to reproduce bioavailability. Metoprolol XL with a once-a-day advantage, has been launched in India. A few ANDAs using this technology have been filed with the USFDA.
Tobramycin + Dexa ophthalmic solution: Unlike the competing product which is a suspension causing gritty feeling in the eye, our product is being developed as a clear solution for use in the prophylaxis of infections after cataract surgery. A pre-IND meeting with the FDA has been completed, with likely IND filing for 2007.
Depot Technology that uses long-acting injectable microparticles for slow/sustained drug release over a month to several months using biocompatible and biodegradable polymers. Our product uses a conventional needle, unlike the competing product where tiny rods are implanted, thus reducing patient trauma and pain. A GnRH analogue is in preclinial trials, with clinical studies slated for 2008. A somatostatin analogue is in clinical studies in India.
Nanoemulsion based products that offer higher drug localization to the cancer cells and fewer side effects were discussed. Our product uses an unique encapsulation process to achieve more than 98% encapsulation of bioactive substance, unlike competing products. Two cytotoxic products are being developed with this technology.
Micromet/TRACON/D93, Arielle Immuno/RTL1000, Arxxant
Micromet and TRACON Pharmaceuticals Sign Exclusive Worldwide License Agreement to Develop and Commercialize D93, a Humanized Antibody for Cancer Treatment
CARLSBAD, Calif., and SAN DIEGO, March 16 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development of novel and proprietary antibody-based products for cancer, inflammatory and autoimmune diseases, and TRACON Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis, today announced an agreement granting TRACON exclusive worldwide rights to develop and commercialize Micromet's D93 antibody with a novel mode of action for the treatment of cancer. TRACON Pharmaceuticals was founded in 2005 by Paramount BioSciences, LLC.
D93 is a recombinant humanized IgG1 monoclonal antibody that inhibits angiogenesis, tumor cell growth and metastasis by targeting cleaved collagen, which is predominantly produced in the extracellular matrix of tumors. Preclinical studies indicate that D93 has the potential to treat different types of cancer as a single agent and in combination with chemotherapeutics. Because of its anti-angiogenic activity, D93 may also provide a new therapeutic approach for other diseases involving
neo-vascularization such as wet age-related macular degeneration or proliferative diabetic retinopathy. In 2006, Micromet filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for clinical testing of D93 in patients with cancer.
TRACON Pharmaceuticals (http://www.traconpharma.com)
Paramount BioSciences, LLC (http://www.paramountbio.com)
Micromet, Inc. (http://www.micromet-inc.com)

Artielle ImmunoTherapeutics Initiates Clinical Trials For Multiple Sclerosis
PORTLAND, Ore./EWORLDWIRE/March 15, 2007 --- Artielle ImmunoTherapeutics, Inc. today announced that the company has initiated a Phase I clinical trial to evaluate its novel drug candidate, RTL1000, for the treatment of multiple sclerosis (MS). RTL1000 is a novel protein drug with a highly-selective mechanism of action that targets pathogenic T-cells responsible for triggering and sustaining MS.
The trial is currently open for enrollment and is a multi-center, double-blind, placebo controlled, single dose Phase I study to be conducted with 30 MS patients in the United States. The clinical trial is designed to assess the safety and pharmacokinetic properties of RTL1000. The study will be conducted at research centers located in New Haven, Connecticut; Indianapolis, Indiana; Kansas City, Kansas; Baltimore, Maryland; Portland, Oregon and Seattle, Washington. Clinical trial information can be obtained at
http://www.clinicaltrials.gov/ct/show/NCT00411723
http://www.nationalmssociety.org/Research-trialsrecruiting.asp
About RTL1000
MS is caused when T cells, part of the body's immune system, target nerves in the spinal cord and brain creating lesions in the myelin sheath. In MS, activation of these T cells triggers the release of inflammatory cytokines that lead to the destruction of the myelin. RTL1000 disrupts the activation of the T cells, preventing the release of the inflammatory cytokines and causing the release of anti-inflammatory cytokines. RTL1000 has been found to be both safe and efficacious in animal models of MS.
http://www.artielle.com

Eli Lilly Withdraws Its Marketing Authorization Application for Arxxant
The European Medicines Agency (EMEA) has been formally notified by Eli Lilly Nederland B.V. of its decision to withdraw the application for a centralised marketing authorisation for the medicinal product ARXXANT (ruboxistaurin). The application for marketing authorisation for ARXXANT was submitted to the EMEA on 30 May 2006. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Isotechnika Receives USAN Approval for Generic Name for Lead Immunosuppressive Drug
Isotechnika Inc. announcedtoday that the Company has received approval from United StatesAdopted Name (USAN) for naming of its lead immunosuppressive drug,ISA247. The name, voclosporin, is now being reviewed by the InternationalNonproprietary Name (INN) expert committee. The INN is scheduled topublish the proposed list of approved names sometime in mid 2007.Official notification from the INN would allow Isotechnika to use thename voclosporin in labelling, publications, and on drug information.The name will serve to identify the active pharmaceutical substanceduring the drugs' life-time worldwide.
ISA247 (voclosporin) is a calcineurin inhibitor, currently beinginvestigated in a Phase 3 European/Canadian trial for the treatmentof moderate to severe psoriasis and a Phase 2b North American trialfor the prevention of organ rejection in kidney transplant patientsand as a treatment for uveitis in three separate pivotal Phase2/Phase 3 trials. The latter trial is being coordinated by ourpartner, Lux Biosciences.
"Moving toward the name of voclosporin from the previousnomenclature of ISA247 should assist us in initiating our commercialbranding process. The next step in the naming process is to requestthat the USAN approved name, voclosporin, be approved by theInternational Nonproprietary Name (INN) Programme of the World HealthOrganization (WHO). Pending receipt of this INN approval, ISA247will, in all future materials, be referred to by its new genericname, voclosporin," commented Dr. Randall Yatscoff, Isotechnika'sPresident & CEO.
CARLSBAD, Calif., and SAN DIEGO, March 16 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development of novel and proprietary antibody-based products for cancer, inflammatory and autoimmune diseases, and TRACON Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis, today announced an agreement granting TRACON exclusive worldwide rights to develop and commercialize Micromet's D93 antibody with a novel mode of action for the treatment of cancer. TRACON Pharmaceuticals was founded in 2005 by Paramount BioSciences, LLC.
D93 is a recombinant humanized IgG1 monoclonal antibody that inhibits angiogenesis, tumor cell growth and metastasis by targeting cleaved collagen, which is predominantly produced in the extracellular matrix of tumors. Preclinical studies indicate that D93 has the potential to treat different types of cancer as a single agent and in combination with chemotherapeutics. Because of its anti-angiogenic activity, D93 may also provide a new therapeutic approach for other diseases involving
neo-vascularization such as wet age-related macular degeneration or proliferative diabetic retinopathy. In 2006, Micromet filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for clinical testing of D93 in patients with cancer.
TRACON Pharmaceuticals (http://www.traconpharma.com)
Paramount BioSciences, LLC (http://www.paramountbio.com)
Micromet, Inc. (http://www.micromet-inc.com)

Artielle ImmunoTherapeutics Initiates Clinical Trials For Multiple Sclerosis
PORTLAND, Ore./EWORLDWIRE/March 15, 2007 --- Artielle ImmunoTherapeutics, Inc. today announced that the company has initiated a Phase I clinical trial to evaluate its novel drug candidate, RTL1000, for the treatment of multiple sclerosis (MS). RTL1000 is a novel protein drug with a highly-selective mechanism of action that targets pathogenic T-cells responsible for triggering and sustaining MS.
The trial is currently open for enrollment and is a multi-center, double-blind, placebo controlled, single dose Phase I study to be conducted with 30 MS patients in the United States. The clinical trial is designed to assess the safety and pharmacokinetic properties of RTL1000. The study will be conducted at research centers located in New Haven, Connecticut; Indianapolis, Indiana; Kansas City, Kansas; Baltimore, Maryland; Portland, Oregon and Seattle, Washington. Clinical trial information can be obtained at
http://www.clinicaltrials.gov/ct/show/NCT00411723
http://www.nationalmssociety.org/Research-trialsrecruiting.asp
About RTL1000
MS is caused when T cells, part of the body's immune system, target nerves in the spinal cord and brain creating lesions in the myelin sheath. In MS, activation of these T cells triggers the release of inflammatory cytokines that lead to the destruction of the myelin. RTL1000 disrupts the activation of the T cells, preventing the release of the inflammatory cytokines and causing the release of anti-inflammatory cytokines. RTL1000 has been found to be both safe and efficacious in animal models of MS.
http://www.artielle.com

Eli Lilly Withdraws Its Marketing Authorization Application for Arxxant
The European Medicines Agency (EMEA) has been formally notified by Eli Lilly Nederland B.V. of its decision to withdraw the application for a centralised marketing authorisation for the medicinal product ARXXANT (ruboxistaurin). The application for marketing authorisation for ARXXANT was submitted to the EMEA on 30 May 2006. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Isotechnika Receives USAN Approval for Generic Name for Lead Immunosuppressive Drug
Isotechnika Inc. announcedtoday that the Company has received approval from United StatesAdopted Name (USAN) for naming of its lead immunosuppressive drug,ISA247. The name, voclosporin, is now being reviewed by the InternationalNonproprietary Name (INN) expert committee. The INN is scheduled topublish the proposed list of approved names sometime in mid 2007.Official notification from the INN would allow Isotechnika to use thename voclosporin in labelling, publications, and on drug information.The name will serve to identify the active pharmaceutical substanceduring the drugs' life-time worldwide.
ISA247 (voclosporin) is a calcineurin inhibitor, currently beinginvestigated in a Phase 3 European/Canadian trial for the treatmentof moderate to severe psoriasis and a Phase 2b North American trialfor the prevention of organ rejection in kidney transplant patientsand as a treatment for uveitis in three separate pivotal Phase2/Phase 3 trials. The latter trial is being coordinated by ourpartner, Lux Biosciences.
"Moving toward the name of voclosporin from the previousnomenclature of ISA247 should assist us in initiating our commercialbranding process. The next step in the naming process is to requestthat the USAN approved name, voclosporin, be approved by theInternational Nonproprietary Name (INN) Programme of the World HealthOrganization (WHO). Pending receipt of this INN approval, ISA247will, in all future materials, be referred to by its new genericname, voclosporin," commented Dr. Randall Yatscoff, Isotechnika'sPresident & CEO.
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.


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.
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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.


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