NEW YORK, March 19, 2015 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCPNK:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic and diagnostic agents for the treatment of Alzheimer's and other neurological diseases, issued the following Letter to Shareholders from Elliot Maza, Chairman and CEO.
Dear Intellect Stakeholder,
I would like to update you regarding certain active programs in the Company's product portfolio.
TauC3 Monoclonal Antibody
In 2011, Intellect filed a new patent application on the use of antibodies targeting certain pathological forms of tau protein for the treatment of Alzheimers Disease. The patent was granted by the United States Patent and Trademark Office (USPTO) and currently is under examination in other regions of the world. In 2012, Intellect acquired from Northwestern University exclusive worldwide development and commercialization rights to the monoclonal antibody, TauC3, for the prophylaxis, mitigation and/or treatment of Alzheimer's disease and other tauopathies as described in Intellect's patent. TauC3 uniquely binds to the TauC3 protein, which is a fragment of tau generated by the action of a proteolytic enzyme early in the course of disease. TauC3 protein is believed to be a particularly toxic form of tau that is responsible for neurodegeneration and propagation of pathology through different regions of the brain.
In 2013, we engaged Dr. Frank LaFerla, Chancellor's Professor and Chair, Neurobiology and Behavior School of Biological Sciences and Director, Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, to conduct a study of our TauC3 monoclonal antibody in a preclinical Alzheimer's mouse model to determine the antibody's potential to be disease modifying. In early 2014, we announced that data from the completed study showed that the TauC3 antibody effectively engaged the target and reduced certain phosphorylated pathological forms of Tau involving modification of single amino acids. The study results indicated that treatment with the peripherally administered antibody had an effect in the brain and is able to be disease modifying.
This month, Intellect initiated a sponsored research collaboration with one of the foremost Alzheimer's disease research centers in the United States to examine the detailed molecular mechanism affecting propagation of tau pathology. The sponsored research collaboration is to support our efforts to develop our TauC3 monoclonal antibody as a therapeutic treatment for Alzheimer's disease and other tauopathies.
Intellect/Shire License Agreement – SHP622
In September 2011, we entered into an Exclusive License Agreement with ViroPharma Inc. related to OX1. In January 2014, ViroPharma merged with Shire Plc. Shire is developing OX1 as a treatment for Friedreich's Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation. Under the terms of the License Agreement, we agreed to transfer to ViroPharma all of our intellectual property rights, data and know-how related to our OX1 research and development program in exchange for payment by ViroPharma of a $6.5 million up-front licensing fee and additional regulatory milestone payments based upon defined events in the United States and the European Union. The aggregate maximum of these milestone payments assuming successful advancement of the product to market could amount to $120 million. In addition, ViroPharma will pay us a tiered royalty based on annual net sales.
In February 2013, ViroPharma filed an investigational new drug application ("IND") to permit initiation of a single ascending dose Phase 1 study to evaluate the safety, tolerability and PK/PD of OX1 (renamed by ViroPharma as "VP 20629" and by Shire as "SHP622") in subjects with FA. Details of the study, entitled "A Phase 1, Randomized, Double-blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral VP 20629 in Adult Subjects with Friedreich's Ataxia" may be found at: www.clinicaltrials.gov; identifier NCT01898884. The trial is ongoing with the final cohort of patients to be enrolled in the near term. Shire has not identified any safety issues that would preclude further development of SHP622 for Friedrich's Ataxia.
Reverse Stock Split
On February 10, 2015, FINRA announced its approval of the 1-250 Reverse Split of Intellect Neurosciences, Inc., which took effect the following day. The Company's Board of Directors recommended the Reverse Split for approval by the Company's shareholders as a means to improve liquidity and strengthen the Company's ability to raise additional capital when needed.
DTC eligibility
In 2013, the Depository Trust Company (DTC) imposed a restriction on physical deposits and electronic DWAC deposits of our stock in the DTC system, adversely impacting the liquidity of our stock. I am pleased to report that effective March 5, 2015, DTC has determined to lift the "Deposit Chill" and has resumed accepting deposits of our stock for depository and book-entry transfer services.
I look forward to updating you on developments related to Intellect's programs in the future. Thank you.
Sincerely,
/s/ Elliot Maza
Chief Executive Officer & CFO
Safe Harbor Statements Regarding Forward Looking Statements
The statements in this letter made by representatives of Intellect Neurosciences relating to matters that are not historical facts , including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those discussed in Intellect's Annual Report on Form 10-K (file no. 333-128226) filed on October 14, 2014 and Quarterly Report on Form 10-Q (file no. 333-128226), filed on February 12, 2015.