Ohr Pharmaceutical (OTCBB: OHRP) CEO Announces Completion of Biotech Transformation With Acquisition of Phase II Drugs
November 10, 2009: 09:00 AM ET
Andrew Limpert, CEO of Ohr Pharmaceutical (OTCBB: OHRP), issued the following letter to Shareholders.
Dear Ohr Pharmaceutical Shareholders:
The last twelve months have been an incredibly busy period for Ohr Pharmaceutical as the company transformed into a biotech company and acquired an exceptionally promising pipeline of drugs in Phase II and Phase I clinical trials.
Under the scientific leadership of Dr. S.Z. Hirschman we completed two acquisitions of pipeline compounds that have had over $100 million of R&D invested in their development.
Ohr's strategy is to advance these products through additional clinical trials and, ultimately, to commercialization, utilizing the industry leading skills of our scientific team and their expertise in superior clinical design.
The team at Ohr is excited to start presenting the Ohr Pharmaceutical story to the investment community for the first time.
Our two lead drugs are
OHR/AVR118 and
EVIZON™.
Ohr acquired OHR/AVR118 through a third party transaction from Advanced Viral Research Corp. in March,
and EVIZON™ was acquired from Genaera Liquidating Trust in August.
OHR/AVR118 is a unique broad spectrum immunomodulator with powerful therapeutic applications for Cachexia, tolerization of cancer chemotherapy and radiotherapy, and autoimmune diseases such as Rheumatoid Arthritis.
EVIZON™ (Squalamine) is a first-in-class anti-angiogenic, for the treatment of wet age-related macular degeneration (wet AMD), a prevalent cause of blindness for those aged 55 and older in the United States.
OHR/AVR118 has shown excellent efficacy and safety in both clinical and pre-clinical trials in over 100 human subjects for Cachexia. OHR/AVR118 is currently in a critical Phase II trial at McGill University for cancer Cachexia and Ohr hopes to complete this trial in mid-late 2010.
Cachexia in cancer patients (often referred to as "wasting away") is believed to be triggered by the cellular stress of chemotherapy, radiation and the cancer itself.
OHR/AVR118 works at the cellular level to moderate the body's harsh immune response and create immunological homeostasis strengthening the patient who can then tolerate much larger dosages of chemotherapy and radiation.
Unfortunately for patients, there is a tremendous unmet need for such a drug. Current Cachexia treatment is limited to steroids with weak efficacy and strong side effects.
Recent trial attempts of TNF inhibitors do not appear to be very effective and are not selective enough to avoid weakening the patients' immune system's ability to fight disease and infection.
OHR/AVR118 has shown very quick efficacy, which allows for shorter treatment periods in clinical trials with lower costs.
Our long term goal is to become the standard of care for the millions of cancer patients who can benefit from higher quality of life and the ability to undergo maximum therapeutic treatment.
EVIZON™ has shown strong efficacy (Visual Acuity gains) in Phase I and Phase II trials in over 200 patients with wet AMD with a better safety profile than the current market leader Lucentis®.
Ohr plans to make a slight improvement in the formulation and delivery of EVIZON™ in attempt to preclude the redness and soreness at the site of infusion that has occurred in a significant minority of patients.
Our goal is to reintroduce the drug, after reformulation, into a Phase IIb trial in late 2010. We believe that the regulatory environment has become much more favorable for gaining FDA approval for a new wet AMD drug.
In summary, I am extremely pleased to report what we have achieved over the past year. We will continue to be carefully focused on advancing development of our two lead drugs, while keeping operating expenses very tightly controlled. While Ohr Pharmaceutical is virtually unknown at this time in the financial markets, we believe there is potential for significant interest as investors learn what we have in development and our market valuation comes in line with other biotech companies with promising multi-drug pipelines and top scientific teams. Thank you for your ongoing support and interest, and I look forward to providing additional updates as we continue to advance towards commercialization of our pipeline in the coming months.
Sincerely,
Andrew Limpert
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (www.ohrpharmaceutical.com) (OTCBB: OHRP) is a biotechnology company dedicated to the development of first in class drugs for underserved therapeutic needs. Ohr is focused on the development of two drugs, OHR/AVR118 for the treatment of Cachexia and EVIZON™ for the treatment of wet-AMD.
money.cnn.com |
