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Australian not-for-profit group wins unprecedented FDA approval for blindness drug

Sunday, July 22nd, 2018

London: An Australian company has won unprecedented US approval for a new drug to treat the second most common preventable cause of blindness in the world.

In the process, Medicines Development for Global Health, based in Melbourne, became the first not-for-profit company in the world to register a medicine with the US Food and Drug Administration.

Mark Sullivan, managing director of Medicines Development for Global Health.

Photo: Supplied

The World Health Organisation has been calling for better treatments for river blindness for more than a decade, but because the medicine would be mostly used by those in poverty-stricken countries, there has been no financial incentive for drug companies to develop new treatments. The current treatment is 20 years old.

River blindness is caused by parasitic worms and spread by black flies. It affects the skin and eyes and is prevalent in sub-Saharan Africa.

In a double-win for Medicines Development for Global Health, it has also won a highly sought after voucher designed to financially reward companies that develop drugs for neglected diseases.

Managing director Mark Sullivan said while FDA approval for the company’s drug, moxidectin, was a “momentous achievement” for any pharma company, it was “a particularly rare and exciting event” for those trying to treat neglected diseases.

The FDA gave its approval for the treatment, which is swallowed as a tablet, in June after the application was submitted in October 2017.

Mr Sullivan established the Melbourne-based not-for-profit company in 2005 with the sole purpose of filling the gap left by the big pharmaceutical companies by developing medicines that were based on need for treatment rather than the patients’ ability to afford them.

Medicines Development for Global Health has been working for five years on the development of the drug and is now planning to develop moxidectin as a new treatment for scabies, a common problem in Indigenous communities.

Priority review voucher

The company has also won a priority review voucher under a scheme set up in 2007 to create a financial incentive to reward drug makers willing to spend the time and money developing treatments for the some of the world’s most neglected diseases. The scheme creates a market for making new drugs that the private market was not filling itself.

Under the scheme, a company that wins a voucher gets a fast track through the FDA for consideration of its  next new drug,  even if it’s a treatment that would have a commercial return. This gives it a head-start over its rivals.

Crucially, a company can also on-sell the voucher to a bigger company willing to pay anywhere between $US100 million and $300 million for the right to almost halve the approval time.

Because Medicines Development for Global Health is a not-for-profit, its proceeds from drug sales and the voucher will be reinvested in the company to develop new drugs & medications for other neglected diseases.

“Our plan is to sell the voucher and use the funds to support further development of moxidectin for other neglected diseases but also to expand our portfolio into other medicines and vaccines,” Mr Sullivan said.

Professor David Ridely from Duke University authored the scheme and said Medicines Development for Global Health was a textbook example of how he envisaged the program would work.

“I’m delighted that the voucher program is playing a role in treating patients with river blindness, and one day eliminating the disease,” he said.

Mr Sullivan said the development of moxidectin could not have been possible without a $US13 million co-investment from the Global Health Investment Fund, which is the social impact investment fund initially put together by the Bill and Melinda Gates Foundation.

”We believe moxidectin may play a pivotal role in eventually eradicating river blindness, and look forward to working with MDGH and others in making this happen,” Curt LaBelle, managing partner at the investment fund, said.

Color-enhanced Scanning Electron Micrograph (SEM) of Onchocerca volvulus, image of a female worm with microfilaria. O. volvulus is a nematode that causes onchocerciasis, or “river blindness,” mostly in Africa. Long-term corneal inflammation, or keratitis, leads to thickening of the corneal stroma which ultimately leads to blindness.

The Food and Drug Administration (FDA) has approved moxidectin for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients ≥12 years of age.

Moxidectin, a macrocyclic lactone, is an anthelmintic drug that selectively binds to the parasite’s glutamate-gated chloride ion channels. It is active against O. volvulus microfilariae but it does not kill adult O. volvulus parasites. The tropical disease spreads from person to person via black flies that breed near rivers in South and Central America, sub-Saharan Africa and Yemen

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Henry Sapiecha

SOME SAY THAT SEA MINERALS & TRACE ELEMENTS WILL EXTEND YOUR LIFE DRAMATICALLY

Monday, April 8th, 2013

Rare Undersea Discovery Could Extend

Your Life by 10, 20 or 30 Years

Rare Undersea Discovery Could Extend Your Life by 10, 20 or 30 Years

Humans have made incredible health strides and are living longer lives than ever.  Many of the maladies that struck down our ancestors have for the most part been completely eliminated – everything from tuberculosis, to polio to malaria.

Today, the biggest killers stem as much from our lifestyles as from microscopic bacteria and viruses.  One of the worst of these is heart disease, and specifically high blood pressure. It’s a slow, but efficient killer that robs many people of what should be the last 10, 20 or 30 years of their lives.

Part of the reason that heart disease is so prevalent and intractable is that it often requires massive changes to one’s lifestyle— changes that are not easy to make.  Everything from radically altering ones diet to implementing serious exercise routines.  And while it’s never too late to start, people often realize the true danger only when it’s too late to make the changes and the damage is done.

Now, however, there may be a scientific breakthrough that could have an impact on high blood pressure comparable to penicillin’s ability treat infections or quinine’s effect on malaria.

Scientists are claiming that they have now isolated unusual ingredients in a rare seaweed discovered by fishermen off the coast of Korea that offer incredible health benefits—including the ability to restore blood pressure to normal levels.

Dr. Haengwoo Lee, a renowned biochemist living near Seattle, Washington conducted a massive 15 year, multimillion dollar clinical study on these two ingredients. The first is Seanol, an extremely rare seaweed extract from Ecklonia Cava that’s proven to be 100 times more powerful than any land-based antioxidant. That’s because it stays working in your body for 12 hours, compared to land-based antioxidants that work for 30 minutes.

“Its secret is its make-up of special polyphenol antioxidants that are a whopping 40% lipid (fat) soluble,” Dr. Lee explains. “Unlike nearly all land-based antioxidants that are water soluble, Seanol’s protective compounds can get into things like the fatty tissues of your brain and penetrate all three layers of your cells, including the outside, the oil-based cell membranes, and your DNA.”

Indeed, Seanol is so powerful, it’s the only FDA-approved Ecklonia Cava marine-algae extract in existence.

The second ingredient is Calamarine, a deep-sea omega-3 discovery that delivers 85% more DHA omega-3s to your heart, brain, joints, and eyes. It’s known to combat everything from fatigue and poor memory, to vision problems, joint pain, mood swings and depression.

With that research in mind, Dr. Lee combined Seanol and Calamarine with a high dose of vitamin D to form Marine-D3, the newest supplement in the fight against age-related illnesses and high blood pressure.

According to the CDC, about 1 in 3 U.S. adults has high blood pressure, which increases the risk for heart disease and stroke, the two leading causes of death in the United States. Increasing your omega-3 intake can reduce high blood pressure, and because it’s difficult to get enough omega-3s in foods like fish and nuts, many people turn to supplements.

AAA

Henry Sapiecha

COLIFORM BACTERIA TEST OF WATER VIA A ‘LITMUS PAPER’ STYLE TEST FOR SAFETY

Wednesday, May 2nd, 2012

CATCHING A COLIFORM BACTERIA INFECTION WHEN SWIMMING IS NOT PLEASANT

Nothing can put a dampener on a summer holiday like a coliform bacteria outbreak. But even worse than being told to keep out of the water in the event of an outbreak is not being told to keep out of the water in the event of an outbreak and ending up paying the price. Researchers at McMaster University have now developed a paper strip test that is cheap to produce, extremely portable, simple to use, and detects E. coli in water in 30 minutes.

While many popular recreational waters are regularly tested for coliform outbreaks, the methods used are generally slow and cumbersome, with samples often having to be sent to a lab for amplification before testing. The new paper strips developed at McMaster overcome all these problems. They work quickly, they are portable, they are simple to use, and they are cheap and easy to produce.

Using inkjet-printing technology, the paper strips are coated with chemicals that change color in the presence of E. coli. Concentrations of the bacteria are indicated by different colors on the strip. While the strips can quickly indicate if water is safe for swimming, they aren’t sensitive enough to identify if it is safe for drinking – a standard that is hundreds of times tighter than for safe swimming water.

However, the McMaster team, led by chemistry professor John Brennan, is planning to conduct field-testing on the prototype strips to help in their refinement that may lead to the development of strips capable of testing the safety of drinking water.

The test strips have been validated by scientists from the Sentinel Bioactive Paper Network, which receives funding from the National Sciences and Engineering Research Council of Canada (NSERC). The NSERC is now funding the next stage of pre-commercial development of the strips, with a possibility the final product will become commercially available in two to three years.

The team’s research is detailed in a paper appearing online in the journal Analytical and Bioanalytical Chemistry.

Sourced & published by Henry Sapiecha

CANCER FIGHTING FISH EGGS FROM WALKING FISH

Thursday, April 14th, 2011

Axolotl eggs could provide

a potent weapon in fight against cancer

By Darren Quick

22:26 January 19, 2011

Researchers have used an axolotl oocyte extract to reactivate tumor suppressor genes and s...

Researchers have used an axolotl oocyte extract to reactivate tumor suppressor genes and stop cancer growing

A common cause of cancer is when cells are altered or mutated and the body’s tumor suppressor genes are switched off. Scientists at the University of Nottingham have managed to bring cancer cells back under control by reactivating the cells’ cancer suppressor genes using an extract from axolotl oocytes. The scientists say the discovery could form a powerful new technology platform for the treatment of a variety of cancers.

The process of cell division is controlled by specific genes and these are turned “on” or “off” depending on their function. Among the most important of these genes are tumor suppressor genes. These genes repress the development of cancers and normally act as a control point in the cell division cycle. Therefore, the switching off of tumor suppressor genes is a common cause of cancers.

The on/off switch in genes is controlled by the modification of proteins that are bound to the DNA in a cell, which are known as epigenetic modifications. Tumour suppressor genes in many cancers are switched off by epigenetic marks, which is the underlying cause of tumors.

In an effort to reverse this process the researchers looked to the axolotl salamander – an animal well known for its ability to regenerate most of its body parts. The scientists found that humans evolved from animals that closely resemble axolotls and therefore, proteins in axolotls are very similar to those in humans. Axolotl oocytes – eggs prior to ovulation – are also packed with molecules that have very powerful epigenetic modifying activity and a powerful capacity to change epigenetic marks on the DNA of human cells.

By treating the cancerous cells with axolotl oocyte extract, the researchers were able to reactivate the tumor suppressor genes and stop the cancer from growing. After 60 days there was still no evidence of cancerous growth.

The researchers say the identification of the proteins in axolotl oocytes responsible for this tumor reversing activity is a major goal of future research, and could form a powerful weapon in the fight against cancer.

The University of Nottingham team’s research appears in the journal

Molecular Cancer.

Sourced & published by Henry Sapiecha