OpinionTEKMIRA PHARMACEUTICALS CORP IN CANADA RECEIVES FDA APPROVAL TO PRODUCE ITS CURE...

TEKMIRA PHARMACEUTICALS CORP IN CANADA RECEIVES FDA APPROVAL TO PRODUCE ITS CURE FOR EBOLA – THE ANSWER TO THE CASES OF EBOLA IN NIGERIA?

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The perception and understanding of the deadly Ebola virus became more apparent in Nigeria with the arrival and demise of Mr. Patrick Sawyer, the Liberian – American Ebola patient who flew in to Lagos, Nigeria and subsequently died on the 25th of July 2014. The Medical Health authorities immediately sprung into action to try their best to stem the spread and quarantine those known to have had direct contact with the late Liberian-American who was said to have attended the funeral ceremony of his late sister in Liberia a few days before.

It is important, to note that as of today, there is NO Ebola virus epidemic in Lagos. The President of Nigeria, President Goodluck Johnathan has however announced a National State of Emergency with the aim of raising the general levels of awareness on the risks of the virus and the necessary precautions needed to prevent the spread in urban and rural communities. The International Air Transport Association (IATA) is coordinating closely with the World Health Organization (WHO) and the International Civil Aviation Organization (ICAO) with respect to potential implications for air connectivity. WHO’s current risk assessment for travel and transport is NOT recommending any travel restrictions or the closure of borders at points of entry. Furthermore, the WHO states that “the risk of a tourist or businessman/women becoming infected with Ebola virus during a visit to the affected areas is highly unlikely as transmission requires direct contact with blood, secretions, organs or other body fluids of an infected person” (IATA Press statement, July 31st, 2014). Similarly, WHO advises that transmission of the virus can only occur when patients are displaying severe symptoms of this disease which takes about 2-21days to manifest.

In a bid to fast track the possible cure of the drug, Tekmira Pharmaceuticals Corp. saw its stock jump more than 22 per cent Friday morning after announcing it has verbal approval from the U.S. Food and Drug Administration that would fast track its new drug to treat the Ebola virus. Today the World Health Organization declared the Ebola outbreak in West Africa to be an international public health emergency and called for extraordinary measures to combat it.

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  • B.C. Ebola remedy developer Tekmira’s share value spikes
  • Ebola outbreak: Experimental treatment sparks who-you-know debate

News that the FDA has applied a “partial clinical hold” on Tekmira’s treatment could clear the way for use of the drugs on infected individuals, the company said in a statement.

It’s stock was up $3.61 at $19.08 on the TSX this morning.

The company started an early stage human clinical trial for the treatment in January and was granted fast-track status from the U.S. FDA on March 5, pushing shares to their highest level, above $33. The trial was put on hold July 3, when some of the patients in the trial experienced problematic immune responses.

The company still is on clinical hold for the multi-ascending dose portion of the study on healthy patients. But the FDA approval will make it possible for single ascending doses to be given to infected patients.

“We are pleased that the FDA has considered the risk reward of TKM-Ebola for infected patients,” Dr. Mark Murray, CEO of the B.C.-based company said in a statement Friday. “We have been closely watching the Ebola virus outbreak and its consequences and we are willing to assist with any responsible use of TKM-Ebola.”

TKM-Ebola is being developed by Tekmira and the U.S. Department of Defence medical team.

Another Ebola treatment, Z-Mapp was used to treat two American aid workers affected with the virus. It was developed by Mapp Biopharmaceutical, Inc. and LeafBio of San Diego, Calif, and Defyrus Inc. of Toronto.

Ebola belongs to a family of viruses that can cause serious hemorrhagic fevers. The recent outbreak, which has killed more than 1,000 people since February, is the worst since the disease was discovered in the mid-1970s.

At Toucan Aviation we continue to monitor the situation and have also taken time to educate our team about the virus and the need to maintain the highest hygiene levels at this time*. We have placed posters all around the EAN Hangar facility which is our operational base as a reminder to the team and also to visitors. We would also like to inform all clients that our operational base at the EAN Hangar is outside of the International and Local Airport environment which further isolates and reduces interaction with the general public. EAN themselves have released a series of effective communications to help educate the general public and its clients. Toucan Aviation’s crew are housed at a private crew house in the Government Reserved Area of Ikeja which is 5 minutes from the airport. We are fully equipped with an international grade chef from Johannesburg. We maintain the highest levels of hygiene at all times and have imported all the necessary protective gear required in the event of any reported emergency.

We are also very pleased that the United States Federal Drug Agency (FDA) has given a verbal approval to change the status on the drug, known as TKM-Ebola Investigational New Drug Application, from a full clinical hold to a partial clinical hold. This action may allow the medicine to be used to treat the growing tally of those stricken by the Ebola virus. We implore the Federal Ministry of Health to lead the way in reaching out to Tekmira Pharmaceuticals Corp to pioneer the administration of this new drug on the few but sadly affected Nigerians currently suffering in isolation centers. This clearly may be a more effective route than seeking out the Z-Mapp Drug that is still awaiting clearance from the United States Government.

On our part, we are confident that the spread of this virus will be curbed. We expect that it will escalate slightly before the new drugs are produced in distributable quantities. With this in mind we will be watching the progress closely.

In all we do, we must remain calm and remember that this virus is communicable by way of direct contact thereby making it less dangerous than the H1 N1 flu virus that broke out in South East Asia. In the case of the H1 N1 flu virus the CDC Influenza Division, used an improved modeling approach which resulted in an estimated range of deaths of approximately 575,400 people who perished worldwide from 2009 H1N1 virus infection during the first year the virus circulated. Clearly we can see that a disproportionate number of deaths occurred in Southeast Asia and Africa, where access to prevention and treatment resources are more likely to be limited. James Ball of The Guardian Newspaper put the issue in clear context in the article he wrote on June the 5th 2014 by saying “Ebola has become the stuff of hypochondriacs’ nightmares across the world. In the UK, the Daily Mirror had “Ebola terror as passenger dies at Gatwick” (the patient didn’t even have Ebola), while New York’s news outlets (and prominent tweeters) experienced their own Ebola scare. Even intellectual powerhouses such as Donald Trump have fallen into panic, with the mogul calling for the US to shut off all travel to West Africa and revoke citizens’ right to return to the country – who cares about fundamental rights during an outbreak? Not to be outdone, the endlessly asinine “explanatory journalism” site Vox informed us that “If the supercontinent Pangaea spontaneously reunited, the US would border the Ebola epidemic”.

Ebola is a horrific disease that kills more than half of people infected by it, though with specialist western treatment that death rate would likely fall a little. It’s unsurprising that the prospect of catching it is a scary one. The relief is that it’s not all that infectious: direct contact with bodily fluids of a visibly infected person is required, meaning that, compared with many illnesses, it’s easily contained. Even in the midst of the current outbreak – the worst ever – the spread of the disease has not been rapid in west Africa: around 400 new cases were reported in June, and a further 500 or so in July. This is a linear spread, meaning each person at present is infecting on average around (actually just over) one additional person.

Far more worrying are diseases that spread exponentially: if one infected person spreads the disease to two or more on average, the illness spreads far quicker and is a much more worrying prospect, even if mortality is considerably lower.

The 900-plus deaths from Ebola in Africa so far this year are indisputably tragic, but it is important to keep a sense of proportion – other infectious diseases are far, far deadlier.

Since the Ebola outbreak began in February, around 300,000 people have died from malaria, while tuberculosis has likely claimed over 600,000 lives. Ebola might have our attention, but it’s not even close to being the biggest problem in Africa right now. Even Lassa fever, which shares many of the terrifying symptoms of Ebola (including bleeding from the eyelids), kills many more than Ebola – and frequently finds its way to the US.

The most real effect for millions of people reading about Ebola will be fear and stigma. During the Sars outbreak of 2003, Asian-Americans became the targets of just that, with public health hotlines inundated with calls from Americans worried about “buying Asian merchandise”, “living near Asians”, “going to school with Asians”, and more. Similarly, during the H1N1 “swine flu” outbreak, which had almost identical spread and mortality to seasonal flu, patients reported extreme fear, prompted largely by the hysterical media coverage. In the coming months, almost none of us will catch the Ebola virus. Many of us, though, will get fevers, headaches, shivers and more”. James Ball in his article boldly left the trail of sensationalist journalism to tell the Ebola story as it is. This is one time that we all need to face reality and get behind the Federal Government of Nigeria as it steps up all efforts to combat the new virus. We look forward to an announcement from the Federal Ministry of Health stating that it has made contact with the Canadian Company Tekmira. The sooner the drug makes its way to our isolation centers, the better for the Nigeria, West Africa and the global community.

Written by Achuzie Ezenagu.
Managing Director/CEO
Toucan Aviation
Lagos, Nigeria

 

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