NEW YORK, Oct. 16, 2012 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for proteinopathies, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO. <\/p>\n
Dear Shareholder, <\/p>\n
I am encouraged by several recent developments that reinforce my confidence in our corporate strategy. Intellect's origins are rooted in my pioneering work from the late 90's that stimulated development of the monoclonal antibodies, which several global pharmaceutical companies have tested as treatments for Alzheimer's disease. While the recently reported Phase 3 clinical trial results for bapineuzumab fell short of expectations, the Alzheimer's community is encouraged by the demonstration using biomarkers that the drug had engaged the target, reduced the amount of plaque and slowed neurodegeneration based upon the decrease in the amount of tau protein measured in the cerebral spinal fluid (CSF). Similarly, Phase 3 data from Lilly's solanezumab appeared to show some clinical benefit in a pooled analysis of early Alzheimer's patients. Lilly is anticipated to present biomarker data at a conference later this month. <\/p>\n
As I wrote in my recent blog, the presenters and expert panelists at the American Neurological Association (ANA) annual meeting in Boston last week conveyed a strong sense that Intellect is correct in its belief beta amyloid (A) plays a central and causative role in the pathogenesis of Alzheimer's disease and that immunotherapy represents a realistic path forward. The next-generation drugs will have an improved probability of success because of the lessons we have learned, especially the need for earlier intervention and careful criteria for the selection of patients to improve homogeneity in clinical trials. <\/p>\n
Importantly, these data support our investment in IN-N01, a next-generation antibody drug candidate that recently completed the humanization process. As explained in our joint announcement with MRC Technology on September 19, we anticipate IN-N01 will have an improved safety profile, which means that it can be used at higher, more frequent doses than the other amyloid-beta antibodies in development. The enhanced dosing likely will result in stronger clinical efficacy, particularly if administered to early stage or presymptomatic patients. We believe IN-N01 could be developed rapidly by using biomarker signals during Phase 2 trials in patients with mild disease, similar to Lilly's approach for solanezumab. This approach should offset the increased costs associated with lengthy trials anticipated to be required in presymptomatic patients. IN-N01 is patent protected until at least the mid-2020s in the United States, Europe and Japan. <\/p>\n
With several license agreements to date and products in clinical development for Alzheimer's disease and Friedreich's Ataxia, Intellect has established an impressive track record of being at the forefront of tomorrow's therapeutic candidates for neurodegeneration. Moreover, based upon conversations with several pharmaceutical companies, we anticipate further transactions for a number of our preclinical assets, which have the potential to generate significant revenues for Intellect, long before any of our products reach the market. <\/p>\n
Pipeline activities: <\/p>\n
Our antibody-drug conjugate platform, CONJUMAB, provides potential development of two independent antibody-based products from the same starting material, our compound, IN-N01. Our recent agreement with Lonza, with whom we signed a letter of intent, was an important step in the development of our first ADC, CONJUMAB-A. We are excited to have reached a point at which Lonza is now manufacturing the preclinical materials for the drug optimization and drug selection program, and look forward to testing these compounds in the near future. With sufficient financial resources, we could reasonably expect to file two INDs within two years, one for CONJUMAB-A initially focused on age-related macular degeneration and a second for IN-N01 for a second indication such as familial Alzheimer's disease or traumatic brain injury, both of which could qualify as orphan diseases. <\/p>\n
Patent news: <\/p>\n
We remain determined to secure our ANTISENILIN patents still under review by the USPTO and hopeful that this can be accomplished over the next few months. The demonstration using biomarkers that bapineuzumab reduces amyloid plaque and neurodegeneration in the brain of Alzheimer's patients provides compelling new evidence in support of the ANTISENILIN platform technology. Similarly, we plan to continue with the appeal process that we initiated in February to overcome the challenge to our patents in Europe. <\/p>\n<\/p>\n
Continued here: NEW YORK, Oct. 16, 2012 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for proteinopathies, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO. Dear Shareholder, I am encouraged by several recent developments that reinforce my confidence in our corporate strategy. Intellect's origins are rooted in my pioneering work from the late 90's that stimulated development of the monoclonal antibodies, which several global pharmaceutical companies have tested as treatments for Alzheimer's disease. While the recently reported Phase 3 clinical trial results for bapineuzumab fell short of expectations, the Alzheimer's community is encouraged by the demonstration using biomarkers that the drug had engaged the target, reduced the amount of plaque and slowed neurodegeneration based upon the decrease in the amount of tau protein measured in the cerebral spinal fluid (CSF). Similarly, Phase 3 data from Lilly's solanezumab appeared to show some clinical benefit in a pooled analysis of early Alzheimer's patients. Lilly is anticipated to present biomarker data at a conference later this month. As I wrote in my recent blog, the presenters and expert panelists at the American Neurological Association (ANA) annual meeting in Boston last week conveyed a strong sense that Intellect is correct in its belief beta amyloid (A) plays a central and causative role in the pathogenesis of Alzheimer's disease and that immunotherapy represents a realistic path forward. The next-generation drugs will have an improved probability of success because of the lessons we have learned, especially the need for earlier intervention and careful criteria for the selection of patients to improve homogeneity in clinical trials. Importantly, these data support our investment in IN-N01, a next-generation antibody drug candidate that recently completed the humanization process. As explained in our joint announcement with MRC Technology on September 19, we anticipate IN-N01 will have an improved safety profile, which means that it can be used at higher, more frequent doses than the other amyloid-beta antibodies in development. The enhanced dosing likely will result in stronger clinical efficacy, particularly if administered to early stage or presymptomatic patients. We believe IN-N01 could be developed rapidly by using biomarker signals during Phase 2 trials in patients with mild disease, similar to Lilly's approach for solanezumab. This approach should offset the increased costs associated with lengthy trials anticipated to be required in presymptomatic patients. IN-N01 is patent protected until at least the mid-2020s in the United States, Europe and Japan. With several license agreements to date and products in clinical development for Alzheimer's disease and Friedreich's Ataxia, Intellect has established an impressive track record of being at the forefront of tomorrow's therapeutic candidates for neurodegeneration. Moreover, based upon conversations with several pharmaceutical companies, we anticipate further transactions for a number of our preclinical assets, which have the potential to generate significant revenues for Intellect, long before any of our products reach the market. Pipeline activities: Our antibody-drug conjugate platform, CONJUMAB, provides potential development of two independent antibody-based products from the same starting material, our compound, IN-N01. Our recent agreement with Lonza, with whom we signed a letter of intent, was an important step in the development of our first ADC, CONJUMAB-A. We are excited to have reached a point at which Lonza is now manufacturing the preclinical materials for the drug optimization and drug selection program, and look forward to testing these compounds in the near future. With sufficient financial resources, we could reasonably expect to file two INDs within two years, one for CONJUMAB-A initially focused on age-related macular degeneration and a second for IN-N01 for a second indication such as familial Alzheimer's disease or traumatic brain injury, both of which could qualify as orphan diseases. Patent news: We remain determined to secure our ANTISENILIN patents still under review by the USPTO and hopeful that this can be accomplished over the next few months. The demonstration using biomarkers that bapineuzumab reduces amyloid plaque and neurodegeneration in the brain of Alzheimer's patients provides compelling new evidence in support of the ANTISENILIN platform technology. Similarly, we plan to continue with the appeal process that we initiated in February to overcome the challenge to our patents in Europe. Continue reading
\nIntellect Neurosciences Issues Letter to Shareholders<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"