Vericel Reports Record 2Q Revenue, Raises Full Year 2018 Revenue Guidance

Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the second quarter ended June 30, 2018.

Second Quarter 2018 Financial Highlights

• Total net revenues of $19.0 million compared to $17.0 million in the second quarter of 2017; second quarter 2017 revenues included a favorable $1.4 million reversal of a revenue reserve for Carticel^® and MACI^® related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer;
• Gross margins of 59% compared to gross margins of 55% on a GAAP basis and 51% on a non-GAAP basis excluding the impact of the revenue reserve reversal in the second quarter of 2017;
• Net loss of $4.7 million, or $0.12 loss per share, compared to net loss of $2.4 million, or $0.07 per share on a GAAP basis and $3.7 million, or $0.11 per share, on a non-GAAP basis excluding the impact of the revenue reserve reversal, in the second quarter of 2017;
• Non-GAAP adjusted EBITDA loss of $1.4 million compared to a loss of $2.7 million in the second quarter of 2017;
• As of June 30, 2018, the company had $95.0 million in cash compared to $26.9 million in cash at December 31, 2017; and
• Full year 2018 revenue guidance raised to $80 to $83 million compared to previous full year revenue guidance of $73 to $78 million.

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MediciNova Starts Phase 2/3 Trial of Med for Degenerative Cervical Myelopathy

MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it plans to initiate a Phase 2/3 trial of MN-166 (ibudilast) in degenerative cervical myelopathy (DCM) in collaboration with the University of Cambridge.

This clinical trial is being conducted under an agreement between MediciNova, the University of Cambridge, and Cambridge University Hospitals NHS Foundation Trust. Funding for this clinical trial is being provided by the National Institute for Health Research (NIHR) in the United Kingdom (UK). The Principal Investigator is Dr. Mark Kotter, NIHR Clinician Scientist, Honorary Consultant in Neurosurgery at the University of Cambridge. This trial will evaluate MN-166 (ibudilast) as an adjuvant treatment for DCM following spinal surgery and determine whether MN-166 (ibudilast) is more effective than placebo in improving outcomes after spinal surgery. Nonclinical studies have shown that inhibiting PDE-4, a well-established mechanism of action of MN-166 (ibudilast), promotes nerve growth in a traumatic spinal cord injury model. This re-growth in the spinal cord may lead to partial or complete recovery of function in DCM patients. MediciNova will provide the study drug supply, regulatory support, and safety monitoring support.

Mark Kotter, MD, Principal Investigator of the study, commented, “We are excited to collaborate with MediciNova to evaluate MN-166 for the treatment of degenerative cervical myelopathy. We believe MN-166’s ability to induce nerve re-growth has potential clinical utility in DCM.”

According to Myelopathy.org, degenerative cervical myelopathy (DCM) is defined as compression of the spinal cord in the neck which can lead to paralysis. DCM is a common, progressive neurological disease caused by aging, arthritis, and degenerative spinal conditions such as spinal stenosis and central disc herniation. According to the American Association of Neurological Surgeons, more than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots. Compression of spinal nerves leads to neurological dysfunction such as numbness, tingling, pain and stiffness in the neck and pain and numbness in the arms, fingers, or hands. Patients may experience muscular abnormalities including, but not limited to, problems with balance and walking, incoordination, muscle weakness in arms, shoulders, or hands, rhythmic muscle spasm, stiff muscles, loss of muscle, overactive reflexes, and loss of bladder and bowel control. Depending on the severity of symptoms, the options for treatment of DCM are a movement-restricting collar, physical therapy, pain relievers, muscle relaxants, and surgery. Currently, no cure exists and there is no approved medication to treat DCM.

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Patients who accepted infected kidneys cured of hepatitis C

Some patients in desperate need of a kidney transplant participated in a bold experiment where they received organs infected with hepatitis C. The gamble paid off.

Their new organs are working fine thanks to medication that got rid of the virus, researchers reported Monday.

It was a small study involving just 20 patients. But researchers say it suggests that organs currently going to waste just might help speed transplants for patients who wait years to get one.

“When there’s such a bad organ shortage, we can’t just do business as usual,” said Dr. Peter Reese, a University of Pennsylvania kidney specialist who led the study. “We need to shake off that these organs aren’t valuable and that people will not want them.”

In the United States, almost 95,000 people are on the national kidney waiting list but only 19,850 received a transplant in 2017, according to the United Network for Organ Sharing. That only covers about 20 percent of all cases.

Hepatitis C is an infection that can quietly destroy someone’s liver if untreated. Transplanting other organs from patients with the virus can infect the recipients. But with powerful new drugs now available that promise to cure them, Reese’s team decided to test if it’s safe to transplant infected kidneys to people who don’t already have the virus —but who might not survive the wait for a healthy organ.

Twelve weeks of hepatitis treatment cleared the virus in all 20 patients tested so far. Compared to patients who received uninfected organs, their new kidneys work just as well, even a year after the procedure. Merck helped fund the research and provided the pills in the study. Results were published in the journal Annals of Internal Medicine.

Kiran Shelat, a 65-year-old civil engineer from Yardley, Pennsylvania, had spent two years on the transplant waiting list before signing up for the experiment.

He now feels energetic, and can work out in the gym and attend family events. So far, there’s no sign of the virus in his bloodstream.

“This is a lifesaver,” Shelat said. “Get off the list; get the kidney. There is nothing to be afraid of.”

Transplant specialists are keeping a watchful eye.

“As long as the patient accepts the risk, I support this,” said Dr. Josh Levitsky, a professor of organ transplantation at Northwestern University who is not part of the team.

Getting an infected kidney may outweigh the burden of dialysis, which many patients find physically exhausting, said Dr. Matthew Cooper, a transplant surgeon at Georgetown University Hospital.

“People have to plan their entire lives around dialysis,” said Cooper, who was not part of the research. “It is a rotten lifestyle.”

It costs about $88,000 a year to undergo dialysis, according to the United States Renal Data System. Merck has set a price of $54,600 for a round of its hepatitis C medication, Zepatier.
Most insurance companies still don’t cover the drug for transplant patients, Reese said.

The American Society of Transplantation has said larger studies are needed before transplanting infected kidneys is done routinely.

In 2016, Johns Hopkins University launched a similar experiment with 10 people. All of them are now cured. Researchers in the United Kingdom are already discussing the possibility to use organs with hepatitis C in patients who don’t have the virus.

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FDA will broaden how it evaluates new addiction treatment drugs

The Food and Drug Administration on Monday announced a shift in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.

Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.

“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.

The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.

MAT, coupled with psychosocial counseling, is widely acknowledged to be the standard of care in treating opioid addiction.

Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.

In its guidance, the FDA said encouraging drug developers to consider outcomes beyond drug use could yield significant health benefits.

The many outcomes Gottlieb cited included mortality (both overall and from drug overdoses) and disease transmission, given the many communities that have seen outbreaks of HIV/AIDS and hepatitis concurrent with increased rates of injection drug use.

“The FDA’s new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery,” health secretary Alex Azar said in a statement.

Despite early missteps in the way some officials, like former health secretary Tom Price, referred to MAT, the Trump administration has long emphasized more evidence-based treatment as part of its means of treating opioid addiction.

But the topic has also led to some controversy in Washington. The White House recently name-checked  a single drug, Vivitrol, a form of naltrexone manufactured by Alkermes, in a strategy document — preferential treatment that addiction experts said could hamstring doctors who should be able to consider all available treatment options. On Capitol Hill, lawmakers spent much of June battling over whether to expand access to buprenorphine, a provision that eventually became part of a major House bill.

The Senate is also expected to make MAT a key element of its response to the opioid crisis, but it remains unclear whether it will consider legislation on the opioid crisis prior to November’s midterm elections.

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Sleeping for 8 hours or more may increase cardiovascular, mortality risk

A worldwide study led by Keele University has shown that people who sleep for more than eight hours each night are at a greater risk of mortality and cardiovascular disease than people who sleep for seven hours or less.

The study also showed that sleeping for ten hours is associated with a 30% increased risk of dying, compared with sleeping for seven hours.

As reported in the Journal of the American Heart Association, lead author Chung Shing Kwok and colleagues studied the link between self-reported sleep duration and quality, cardiovascular outcomes and mortality across 74 studies including more than 3 million people.

“This research began because we were interested to know if it was more harmful to sleep below or beyond the recommended sleep duration of seven to eight hours. We further wanted to know how incremental deviation from recommended sleep duration altered risk of mortality and cardiovascular risk,” says Kwok.

The study also found that sleeping for ten hours increases the risk of death from stroke by 56% and the risk of death from cardiovascular disease by 49%.

Kwok says the findings have important implications for the public because they show that too much sleep can increase cardiovascular risk. They also have important clinical implications because they suggest that doctors should ask more about sleep duration and quality when talking to patients.

If excessive sleep patterns are found, particularly prolonged durations of eight hours or more, then clinicians should consider screening for adverse cardiovascular risk factors and obstructive sleep apnea, which is a serious sleep disorder that occurs when a person’s breathing is interrupted during sleep,”

Chung Shing Kwok, Keele University

The results are evidence that sleeping for longer than the recommended seven or eight hours could be linked to a moderate degree of physical damage, compared with sleeping for fewer hours.

“The important message is that abnormal sleep is a marker of elevated cardiovascular risk and greater consideration should be given in exploring both duration and sleep quality during patient consultations,” concludes Kwok.

Source:

• https://www.keele.ac.uk/research/

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Google Reportedly Pitching Tech to Senior Housing Communities

The division of Google (Nasdaq: GOOG) that makes automated home products could begin making smart devices designed for senior housing communities.

The internet tech giant is reportedly approaching senior living communities to gather feedback on how it can tailor its Nest devices to older adults, according to CNBC. Preliminary ideas range from motion sensors that help people use the restroom late at night, technology to notify seniors when they’re at risk of dehydration, and using sensors to track and prevent falls.

Perhaps signaling an intention to learn more about the senior housing space, Nest Chief Technology Officer Yoky Matsuoka is slated to speak at this year’s National Investment Center for Seniors Housing & Care’s (NIC) conference in Chicago this October.

Google is not the first tech company to quietly explore senior living as a new service line. Earlier this year, online retail giant Amazon.com (Nasdaq: AMZN) reportedly took a multi-city bus tour that included input from senior living innovator Bill Thomas. The company was also rumored to be developing a “top-secret” robot that would follow people around the house and provide assistance.

More generally, both Nest and Amazon devices are useful in senior housing settings. Some large senior living providers—such as Glendale, California-based Front Porch—are indeed experimenting with the technology. Still, others say voice-activated devices and other tech innovations for older adults aren’t quite ready for widespread use.

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Solving insolubility produces method to deliver curcumin to cancer cells

Researchers detailed a hierarchical approach to solubilize a hydrophobic anti-cancer drug, curcumin in water via a combination of coordination-driven self-assembly and host-guest interactions.

Credit: University of Illinois Laboratory of Materials in Medicine

In India and other countries in Southeast Asia, curcumin is often used as a spice in cooking, particularly chicken or fish. It is known for its therapeutic effect and as a way to kill germs present in raw meet. Recently, scientists have also discovered that curcumin, a naturally occurring substance isolated from the Curcuma long plant, to be an effective agent for killing cancer cells.

“Until now, however, curcumin is what we call in pharmaceutical science as a ‘false lead’ — it is therapeutic, but the full effect can’t be utilized because it’s poorly soluble in water,” noted Dipanjan Pan, an associate professor of bioengineering at the University of Illinois at Urbana-Champaign who leads the Laboratory of Materials in Medicine.

“When you try to deliver a drug, it requires solubility in water, otherwise it won’t flow through the bloodstream,” added Santosh Misra, a post-doctoral researcher working with Pan.

Recently, however, Pan’s laboratory collaborated with Peter Stang, the editor-in-chief of the Journal of American Chemical Society, and Distinguished Professor of chemistry at the University of Utah on ways to be able to render curcumin soluble, deliver it to infected tumors, and kill cancer cells. The team has created a sophisticated metallocyclic complex using platinum that has not only enabled curcumin’s solubility, but whose synergy has proven 100 times more effective in treating various cancer types such as melanoma and breast cancer cells than using curcumin and platinum agents separately. They published their results in the Proceedings of the National Academy of Sciences of the United States of America

“It’s a combination of clever chemistry and nanoprecipitation utilizing host guest chemistry,” Pan explained. “We know that a drug is going to bind to a certain ‘host molecule’ if the proper pocket is present. We have shown here that a pumpkin-shaped macrocyclic molecule Cucurbituril by virtue of its glycoluril monomeric linkages, that attracts curcumin, which gets bound and comes off once it gets delivered to the cell. That is the key to demonstrating the effectiveness of the therapy and in solving a long-standing problem with curcumin’s insolubility.”

“In order to make it available to the system, it was necessary to put curcumin in a larger complex where it can be soluble in water,” Misra said. “This complex has a very unique ability to take on different forms of material — from a spherical nanoparticle to longer elongated threads of nanometer size. In both cases, curcumin is present in the system, which what is important for to its medicinal value.”

“We knew platinum is a commonly used cancer therapeutic agent in the clinic,” Pan said in explaining the road to discovery. “We wanted to exploit that property as well in addition to curcumin. Our results demonstrate that curcumin works completely in sync with platinum and exert synergistic effect to show remarkable anticancer properties.”

The team detailed a hierarchical approach to solubilize a hydrophobic anti-cancer drug, curcumin in water via a combination of coordination-driven self-assembly and host-guest interactions.

Curcumin has shown to prevent the phosphorylation of STAT3, a well-known signaling pathway that triggers the growth of cancer cells and allows them to survive, in in vivo studies. The platinum-curcumin combination kills the cells by fragmenting its DNA.

Although the researchers have only tested the method in delivering curcumin, its contribution to cancer treatment will ultimately also come from the likelihood the method will work with other drugs as well.

“In cancer therapy, one of the measures that constrains a number of the drugs is their poor solubility,” Pan said. “Viability only becomes prominent when the drug becomes soluble in water. So, no matter how the drug is given, intravenously or orally, it needs to eventually be absorbed by the organs in the body.”

Pan’s team also hopes to prove that this method will be effective in killing cancer stem cells, in effect cancer’s root system.

“More and more it is becoming obvious that cancer stem cells are responsible for all these cancers to regrow,” Pan said. “Even if you are killing all the cells in the tumor, there would be a tiny population of cells with ‘stemness’ properties that could enable cancer cells to grow back and spread to other parts of the body. That is why even if a patient has been declared cancer free, doctors continue to monitor to see if cells regrow. However, if we can deliver therapy to cancer stem cells, we can prevent that from happening. As an ongoing research in our laboratory to find agents for stopping the growth of cancer stem cells, we will be looking into using these highly sophisticated self-assembled metallacycles for targeted therapies”

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Story Source:

Materials provided by University of Illinois College of Engineering. Original written by Mike Koon. Note: Content may be edited for style and length.

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Journal Reference:

1. Sougata Datta, Santosh K. Misra, Manik Lal Saha, Nabajit Lahiri, Janis Louie, Dipanjan Pan, Peter J. Stang. Orthogonal self-assembly of an organoplatinum(II) metallacycle and cucurbit[8]uril that delivers curcumin to cancer cells. Proceedings of the National Academy of Sciences, 2018; 201803800 DOI: 10.1073/pnas.1803800115

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