Tamir Biotechnology Provides Update on TMR004 Development Against Mutating Ebola

Apr 30, 2015, 17:42 ET from TamirBio

SAN DIEGO, April 30, 2015 /PRNewswire/ -- Tamir Biotechnology, a leading developer of RNA modulating drugs, announced today an update on its Ebola antiviral therapy program.

Clinical Progress
One of Tamir's leading candidates, TMR004, is currently being evaluated and considered by a number of clinicians on the frontline of the battle against Ebola. During the first quarter of 2015, the company participated in the African Voice And Leadership Meeting To Accelerate The Evaluation of Potential Treatments and Vaccines For Ebola In West Africa. At the conference, which took place in Dakar, Senegal, Tamir presented TMR004 and its preeminent role as a broad spectrum antiviral in the development of effective treatment against Ebola virus. The Company is now exploring a number of opportunities with leading clinicians in West Africa. "TMR004 represents a real opportunity against the mutating threat of Ebola in our region and we are excited to explore its potential role," noted Professor Ibrahima Sec, MD, PhD, Director of Studies, University of Dakar, Senegal.

Pre-Clinical Validation
The company also this week received additional data from its continued investigation into the anti-Ebola properties of TMR004. In a therapeutic pre-clinical mouse model conducted at the University of Texas Medical Branch, the drug was administered intraperitoneally at three dose levels to animals previously infected with the Ebola virus. TMR004 conferred a statistically definitive survival advantage relative to the control group. This finding was consistent with earlier investigations in which the US Army Medical Research Institute for Infectious Diseases showed that prophylactically administered TMR004 confers one of the highest survival rates observed for experimental drugs in the fight against Ebola virus. More studies are planned for the immediate future in additional animal models of infection.

TMR004-- A Second Chance With Known Safety
TMR004, the Company's leading candidate, has a rich legacy as a therapeutic agent. This type III RNase is able to inhibit viral replication through halting synthesis of viral protein without altering cellular constituents. It is noteworthy that since TMR004 degrades double stranded RNA produced by most viruses, it less likely that viruses will develop resistance despite the high mutation rates seen with pathogens like Ebola. A form of the drug, formerly known by the ONCONASE trademark and as "Onconase for injection", was previously evaluated by the US Food and Drug Administration for over twenty years in numerous clinical trials.  Its safety was considered sufficient to permit administration to over 1,000 patients as part of its development against malignant mesothelioma. Armed with this history of safety and preclinical data supporting antiviral activity, management successfully restructured the organization in 2014 and redirected the organization's focus as an antiviral platform.

Today, the company is actively pursuing different avenues within the US Government to continue the development pathway of TMR004 against Ebola in concert with its clinical efforts in West Africa.  As the agent can be delivered intravenously (IV), is stable under extreme temperatures, and is readily scalable in a period of 4-6 weeks, the agent represents a viable approach in the global battle against Ebola. "We are pleased with the development of TMR004 as an antiviral and expect 2015 to showcase its ability to combat Ebola along with a host of other global viral threats," noted Dr. Tom Hodge, Director of Antiviral Research at Tamir (Dr. Hodge was formerly Immunogenetics Lab Director, HIV/AIDS, Host Pathogen Interaction at the U.S. Government Centers for Disease Control and Prevention in Atlanta, Georgia).

About TamirBio

TamirBio is a clinical stage antiviral therapeutics company engaged in the discovery and development of a new class of prophylactic and therapeutic drugs for the treatment of viruses and other pathological conditions. TamirBio first target is the human papilloma virus (HPV), the worldwide leading cause of genital warts. TamirBio is also targeting the acute treatment of the Ebola virus (EBV).

Throughout 2013 and the first half of 2014, TamirBio operations were successfully restructured, including privatization of the company, to support our new focus, along with attracting a strong team of experienced biotechnology professionals. The company has successfully initiated its clinical activity in HPV along with securing independent, third-party validation of anti-viral properties for its leading licensing candidates.

Disclosure Notice
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and TamirBio may take in ultimately seeking commercial approval of the TMR004 for various treatments in the United States. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of TMR004 in the United States and other countries.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of TamirBio involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release. The final results of these efforts could vary materially from TamirBio's expectations. Findings from animal studies may not correlate with results from humans. Clinical trial data will be necessary to establish human efficacy of TMR004 for Ebola virus disease.

Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by TamirBio that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond TamirBio's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and TamirBio undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that TMR004 will ever be commercially approved for the new potential treatment indications mentioned in this release.