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Wednesday, 7 August 2013
NanoViricides stock up almost 20%, hits new 52-week high on back of NDA
Stock in NanoViricides (OTCBB:NNVC) spiked today, adding 18 cents in intraday trading to hit as high as $1.16 per share, marking both an increment in share price of just under 20 per cent and a new 52 week high for the drug development company.
The sudden surge in share price comes a matter of days after the news that the Connecticut-based nano-biopharmaceutical company had signed a non-disclosure agreement with the Lovelace Respiratory Research Institute with the intent of furthering its plan to conduct drug studies of both its broad-spectrum injectable and oral FluCide candidates.
The NDA has significance as an indicator of progress being made in that it allows the two companies to exchange confidential and proprietary information in preparation for intended studies.
The drug development company, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, anticipates inking a master services agreement with private biomedical research organization Lovelace, for the efficacy studies to be conducted in advance of the investigational new drug (IND) application.
The studies are planned to make use of numerous unrelated strains of influenza A. NanoViricides has already proven, through animal studies, that both versions of its FluCide drug candidate are more effective than the current standard of care, Tamiflu, in controlling influenza A virus infections, namely H1N2 and H3N2.
NanoViricides' injectable FluCide drug is designed for severely ill hospitalized patients, while the oral version is aimed at outpatient use. On the advice of the FDA during the company's pre-IND meeting, it will test both drugs against several unrelated subtypes of influenza A, including H7N9, which is considered a potential pandemic threat.
In addition to FluCide, New Mexico-based Lovelace will be allowed to test the company's candidate for MERS (Middle East Respiratory Syndrome) – an ailment named as a potential threat to public health and national security by the Obama administration in June.
The news follows the recent execution of another NDA with the UK Public Health Agency for the testing of its FluCide candidate against the A/H7N9 strain as well as new drug candidates against the emerging MERS virus.
According to a company statement issued earlier in the week, NanoViricides believes that simultaneously testing of the drug candidates at these two sites should result in a dataset yielding a "high degree of confidence". Its FluCide drug has the potential to wipe out virtually all strains of the influenza A virus. Toxicology studies are expected to be wrapped up before mid-2014.