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New Treatment for Pediatric Ulcerative Colitis Submitted for FDA Orphan Drug Classification

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A New, Non-Corrosive, Non-Irritating Treatment for Pediatric Ulcerative Colitis Has Been Submitted for FDA‘s Orphan Drug Classification

Financial Press Commentary

(FinancialPress) — The US Federal Drug Administration (FDA) has received an orphan drug designation request from Vitality Biopharma Inc. (OTCQB: VBIO)—a cannabinoid prodrug pharma corporation in the process of developing its flagship asset VITA-100, targeting the treatment of pediatric ulcerative colitis.

A positive response from the FDA’s Office of Orphan Products Development stands to benefit the company as it continues to develop the treatment.

The drug could potentially serve to alleviate the pediatric condition – which holds a rare disease classification itself.

VITA-100 holds the particular distinction of being based on Vitality’s proprietary “cannabosides” technology—a delivery system aimed to deliver therapeutic-grade cannabinoids (THC and CBD) directly to the targeted area in the gastro-intestinal tract without the composite entering the bloodstream. The benefit of this delivery method is the avoidance of all psychoactive effects traditionally associated with it.

“In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications,” said Robert Brooke, CEO and Co-Founder of the company.

“Given the mounting clinical data documenting use of cannabinoids for treatment of gastrointestinal disorders, we are very excited about the potential of VITA-100 and our cannabosides platform to provide a meaningful impact for these patients, helping them to stabilize their disease and avoid debilitating surgeries,” he added. 

The cannabosides technology has already been tested and demonstrated as effective by the company—particularly in preclinical models of colitis.

The non-intoxicant formulation also helped reduce the side effects that often come with similar treatments such as weight loss, damage to the colon and overall improved GI health when compared to placebos.

The restricted delivery-drug, enabled by the company’s know-how in enzymatic glycosylation, is geared up to be available as an oral pharmaceutical.

Formerly a stevia-focused company, Vitality is one of the few companies operating in the cannabinoid pharmaceutical sector.

It found its niche in obtaining its own intellectual properties in the aforementioned delivery system.

Their inaugural discovery in the field came as it attempted to make stevia taste better. They found a much better – and more exploitable – result in lieu.

Therapeutic synthetic THC, AKA dronabinol, has been an instrumental factor in giving companies such as Vitality a head start over the rest of the medicinal cannabis sector, as the FDA‘s 2016 approval has allowed them to delve deeper into the medical uses and benefits of the cannabinoid.

The legal THC sector has been making waves ever since the approval, with companies such as Valeant Pharmaceuticals, Inc. (NYSE: VRX) (TSX: VRX) and INSYS Therapeutics, Inc. (NASDAQ: INSY) releasing their products Marinol and Syndros respectively – both of which use the cannabis derivate as the active ingredient. GW Pharmaceuticals plc (NASDAQ: GWPH) is also expected to have its Sativex (naxibimol) product approved soon.

Vitality‘s submission brings it one step closer to tapping into the massive medicinal cannabinoid market, putting it neck and neck with the giants of the sector while having only a fraction of, for example, GW‘s $3.723 billion market cap.

POTENTIAL COMPARABLES

Valeant Pharmaceuticals, Inc. (NYSE: VRX) (TSX: VRX)

Valeant operates as a pharmaceutical and medical device company worldwide. Among its many products, the company offers Uceris to get ulcerative colitis under control; and Zegerid to treat certain stomach and esophagus problems; Tobramycin and Dexamethasone ophthalmic suspension for steroid responsive inflammatory ocular conditions; and Latanoprost medicines to treat a type of glaucoma. The company was founded in 1983 and is headquartered in Laval, Canada.

INSYS Therapeutics, Inc. (NASDAQ: INSY)

Insys Therapeutics, Inc., is a specialty pharmaceutical company, which develops and commercializes supportive care products. The company markets SUBSYS, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant cancer patients in the United States. Its lead product candidate is SYNDROS, an orally administered liquid formulation of dronabinol for treating CINV and anorexia associated with weight loss in patients with AIDS. The company is also developing Cannabidiol Oral Solution, a synthetic cannabidiol for childhood catastrophic epilepsy syndromes; and other product candidates, including other dronabinol line extensions and sublingual spray product candidates. Insys Therapeutics, Inc. is headquartered in Chandler, Arizona.

GW Pharmaceuticals plc (NASDAQ: GWPH)

GW is a biopharmaceutical company, engaging in discovering, developing, and commercializing cannabinoid prescription medicines derived from the Cannabis plant. GW markets Sativex, for the treatment of spasticity due to multiple sclerosis, which is also in Phase II trials for neuropathic pain. Their product pipeline includes Epidiolex, which is in Phase III clinical development to treat dravet syndrome, lennox-gastaut syndrome, tuberous sclerosis complex, and infantile spasms. GW Pharmaceuticals plc was founded in 1998 and is based in the UK.

About Vitality Biopharma (OTCQB: VBIO)

Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn


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Cannabis

Nationwide US cannabis legalization lawsuit movement scores an L

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(FinancialPress) — The first legal battle held by the lawsuit levvied against the federal government, launched by cannabis legalization advocates, finds the plaintiffs on the losing side.
Judge Alvin Hellerstein, who officiates for the U.S. District Court in the Southern District of New York, ruled that the plantiffs “failed to exhaust all administrative remedies“ to settle their request, and therefore granted the motion to dismiss filed by the U.S. Justice Department.
The suit argues for the unconstitutionality of the 1970 Controlled Substances Act, and requested that marijuana be reclassified from the schedule of controlled narcotics.
Had the suit been successful, marijuana would have been immediately legalized country-wide.

The ruling will be appealed by the plaintiffs – a group that includes a young epileptic girl and former NFL players.

Hellerstein‘s ruling read as follows:

“Although plaintiffs couch their claim in constitutional language, they seek the same relief as would be available in an administrative forum – a change in marijuana’s scheduling classification – based on the same factors that guide the (Drug Enforcement Administration’s) reclassification determination.”

The judge emphasized the fact that the ruling was an administrative measure, and should not be taken as support towards the notion of that marijuana should remain classified a Schedule I drug:

“This decision should not be understood as a factual finding that marijuana lacks any medical use … the authority to make that determination is vested in the administrative process,” he wrote.

He also denied the plaintiffs‘ claim of that using marijuana is a fundamental right of theirs.

“No such fundamental right exists,” he wrote.

“Every court to consider the specific, carefully framed right at issue here has held that there is no substantive due process right to use medical marijuana.”

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Alibaba bets big on Olympics for household recognition

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(FinancialPress) — The biggest e-commerce portal in China is making a strong investment as an Olympic sponsor for the Pyeongchang Olympic games. The imposing pavilion the company put up at the event is in line with the ones erected by giants Coca-Cola, McDonald‘s and Samsung.

With this, Alibaba (BABA) likely hopes that some of the 3 other giants‘ global recognition rubs off on it.

The Jack Ma-founded company made waves with its 2014 New York Stock Exchange IPO – the largest recorded in history. The eccentric frontman is a regular at major international events, and just last year was part of a photo op with US President Donald Trump.

However, despite its massive success in Asia, its  “brand awareness outside China is not commensurate with its size,” according to National University of Singapore marketing professor Junhong Chu. Alibaba‘s market value is larger than Walmart‘s, and the company looks to change that with the Olympic sponsorship.

The requirements of the contract are extensive – minimum commitment of 4 years, and hundreds of millions in investment. While the exact numbers are not required to be made public, a report states that BABA‘s estimated investment will border $800 milion for the duration of the deal, which ends in 2028. This puts the company shoulder-and-shoulder with name giants such as Toyota, GE and Visa.

Alibaba steps in at a critical time – as longtime main sponsor McDonald‘s announced it will end its deal with the Olympics 3 years early. Not only does the new partnership bridge that financial hole, but a spokesperson for the Asian giant also stated that it comes “at a very critical time,” and that it will use its technology to help make the Olympics “more efficient, secure and engaging,”

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Ethereum founder warns about cryptocurrencies as bitcoin breaks $11,000 again

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(FinancialPress)  —  Bitcoin’s rebound continued on Monday as it recovered from the depths reached on February 6th, by closing at $11,000 – a massive recovery from the below-$6000 value it had reached at its lowest of 2018. Even so, Ethereum’s founder took the time to warn her that cryptocurrencies still “could drop to near-zero.”

At the time of this publication, Bitcoin sits steady at over $11,505 on Coindesk. Bitcoin returned to over $10,000 of value last Thursday. Factors to be considered for the rise are the fact that Bitcoin Investment Trust had a strong surge last week – as it grew in unison with Bitcoin and other recovering cryptos. Meanwhile, a CNBC investigation caused Riot Blockchain to lose considerable value.

After an all-time high of $20,000, Bitcoin drastically stumbled in December after regulators from major financial hubs, such as China and South Korea, began cracking down on the cryptocurrency market. Fast forward to today, and the latter is also a leading factor for the continuing rise in the digital currency‘s value, as enthusiastic trading occurs in the Asian country. The recovery began on February 6 after a Senate hearing in the US in which regulators warned about the cryptocurrency market, but did not signal that they would be aggressively pursuing regulation or restricting trading in any way.

The re-surge is condimented with comments from top cryptocurrency Ethereum, Vitalik Buterin, who said in a tweet that cryptocurrencies as a whole are a “new and hyper-volatile asset class“.

Ethereum, Ripple and Litecoin all closed with gains Monday.

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