HCA Hospital Launches Training Program for Robotic Guided Spine Surgery

 The Virginia Institute of Robotic Surgery at Reston Hospital Center has announced the launch of its Visiting Clinician Program (VCP) for robotic assisted spine surgery using the Mazor X Robotic system, a partnered program with Medtronic. The VCP at Reston Hospital Center will be led by Dr. Christopher Good, spinal surgeon at the Virginia Spine Institute (VSI). As the Director of Scoliosis & Spinal Deformity Surgery at VSI, Dr. Good is at the forefront of spine surgery and has performed the Mid-Atlantic’s first and most advanced procedures using robotic assisted technology at Reston Hospital Center.

“Our team has been leading the way in implementing the latest in surgical innovations for years,” said John Deardorff, President and CEO of HCA’s Northern Virginia Market and Reston Hospital Center. “Consistently providing excellent patient care and superior results, Reston Hospital Center has become recognized as a destination that surgeons from around the world come to train.”

The VCP at Reston Hospital Center is designed to enable spine surgeons from around the world to see the technology while learning best practices for implementation in another facility or surgical program.

 A visit to the program includes a case observation, as well as an opportunity to complete a training curriculum and to spend time with Dr. Good, learning the technology and how its best applied in complex cases. Visiting surgeons will also be exposed to the daily operations of running a comprehensive robotic surgery program from the administrative perspective, while having the opportunity to speak with leadership from the surgical services area.

“Our research is showing that this robotic technology can decrease radiation to patients in the operating room, as well as improve the safety for patients having spine surgery,” said Dr. Christopher Good. “The launch of this Visiting Clinician Program at Reston Hospital Center is just one more step toward ensuring that our patients have the safest and most advanced treatment available to them; and, now, I have the pleasure of giving the same opportunity to surgeons around the world.”

The robotic assisted technology is used for pre-planning minimally invasive as well as complex spinal reconstruction procedures. It allows spine surgeons to precisely plan out the desired surgery and to carry out the procedure with a high degree of confidence and accuracy.

Part of HCA Virginia Health System, Reston Hospital Center is a 187-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence.  Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourth‐largest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com. 

https://finance.yahoo.com/news/reston-hospital-center-launches-training-202105041.html

Elevian set up to pursue disputed approach to aging diseases

New startup Elevian has launched with $5.5 million in backing to develop drugs based on GDF11, a Harvard University-discovered protein that it says is linked to age-related diseases.

GDF11 (growth differentiation factor 11) hit the headlines a few years back when researchers led by Harvard cell biologist Amy Wagers, Ph.D., published studies suggesting the protein was behind research dating back decades which shows that blood taken from young mice and administered to older animals could help rejuvenate organs.

Their work on GDF11—which involved a technique called parabiosis in which the circulatory systems of young and old mice were combined to allow blood to flow between the animals—suggested that injecting the protein into old mice regenerated cardiac, brain and muscle tissue. It was named Science’s breakthrough of the year in 2014.

The hypothesis quickly became controversial, however, when another research group from the Novartis Institutes for Biomedical Research (NIBR) tried and failed to reproduce the findings, and in fact concluded that GDF11 increases with age and inhibits skeletal muscle regeneration. Since then, the two groups have traded blows over the integrity of their studies and research methods, but Elevian says it has data coming out that will firm up evidence that the protein plays a key role in anti-aging.

Wagers is one of the scientific founders of San Francisco-based Elevian, which is led by Mark Allen, M.D., who was most recently CEO of business decision-making software company Corticon Technologies before its sale to Progress Software in 2011.

“Elevian’s therapeutic strategy is to modulate upwards active GDF11 levels, which can be achieved by exogenous administration of recombinant protein as well as by targeting natural regulation mechanisms of GDF11,” Allen tells FierceBiotech.

The new company is pursuing preclinical programs in cardiovascular disease, Alzheimer’s disease, Type 2 diabetes and age-related muscle dysfunction (sarcopenia). Elevian’s CEO says, “we expect to have completed preclinical efficacy and safety studies in multiple therapeutic indications and initiate our first human clinical studies in 2-3 years.”

He goes on to say that the company reckons it can achieve a successful human proof-of-concept relatively quickly in each of these indications.

“Our cardiovascular program, in particular, is supported by human clinical data from the laboratory of Peter Ganz at UCSF, demonstrating that patients with low levels of a measure of GDF11 have significantly increased mortality rates,” says Allen.

Getting approval in those lead indications would require expensive large-scale, time-consuming studies, however, so the company “is also considering additional indications that may provide a faster regulatory path,” according to Allen.

He also notes that Elevian is currently pursuing a much bigger funding round to raise capital to take “two or more different product candidates” through the Investigational New Drug (IND) application stage.

Elevian’s other co-founders include scientists from Harvard’s stem cell and regenerative biology group who have been involved in work on GDF11, notably Lee Rubin, Ph.D., who has looked at the protein’s effects on brain vasculature and neurogenesis, and Rich Lee, M.D., who specializes in heart failure and metabolic diseases that accompany human aging.

“Elevian has exclusive worldwide rights under a portfolio of patent families licensed from Harvard and its research partners broadly claiming methods and compositions for modulation of GDF11 to treat diseases and conditions related to aging,” says Allen.

“Our scientific co-founders are in the process of publishing new data that we believe will help to elucidate some of the open questions regarding GDF11 biology, as well as its therapeutic effects in various disease models.”

The round was led by Bold Capital, the investment firm of Peter Diamandis, and included WTI, Stanford StartX fund, Longevity fund, Kizoo Ventures, Thynk Capital and others.

https://www.fiercebiotech.com/biotech/elevian-set-up-to-pursue-disputed-approach-to-aging-diseases

Roche faces UK pricing row over multiple sclerosis drug

Roche (ROG.S) faces a fresh row over drug pricing in Britain, following a decision by the body responsible for medicine use within the state health service not to approve its drug Ocrevus for treating a highly disabling form of multiple sclerosis (MS).

In June, the National Institute for Health and Care Excellence (NICE) endorsed Ocrevus for relapsing-remitting MS – the most common type of the disease – but it has now rejected it for the rarer and more severe primary-progressive form of MS.

Ocrevus is the only available treatment for primary-progressive MS (PPMS), while there are several drugs for relapsing-remitting MS (RRMS), and Roche UK general manager Richard Erwin said Monday’s decision was “devastating news” for patients.

It is not the first time the Swiss drugmaker has clashed with NICE, which determines if drugs are cost-effective enough to be used in the National Health Service (NHS) in England and Wales.

Roche has also battled to get a number of its cancer drugs approved by NICE in the past, prompting Chief Executive Severin Schwan to brand Britain’s health system as “stupid” three years ago here

Roche Holding AG238.2

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In the case of Ocrevus, Roche said it had reached a stalemate because the authorities were not allowed to even consider a confidential discounted price for using the drug in PPMS that was different from the RRMS price.

That is a problem because the evidence showing the benefit of Ocrevus in PPMS is not as compelling as in RRMS, so a lower price would be needed to reach NICE cost-effectiveness thresholds.

The restriction meant NICE had to consider the existing RRMS approved price for the PPMS indication and this was deemed too expensive. In a statement, NICE said the size and duration of the drug’s benefits in PPMS were uncertain and it could not be considered an acceptable use of NHS resources.

Worldwide, Ocrevus has proved to be a big commercial success for Roche, with sales topping $1 billion in the first half of 2018, and the company said it hoped an agreement could be reached for its use within the NHS.

“Roche is confident that given the flexibility to offer an indication-specific price, we will be able to offer a price that is deemed cost-effective for PPMS,” the company said.

https://uk.reuters.com/article/uk-roche-britain/roche-faces-uk-pricing-row-over-multiple-sclerosis-drug-ocrevus-idUKKCN1LP0V5

Why CMS’ Step Therapy Decision Is so Dangerous

Practicing medicine today requires balancing cost, treatment timing, and access to the best therapies for patients. This is especially critical in cancer, where the costs of newer agents have entered the stratospheric range, and where more narrowly defined treatments based on molecular selection are optimal. This competing need—to control costs while preserving good care—is understandable, and one way to address this challenge is to limit access to more expensive treatments.

Recently, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare Advantage programs are now allowed to require step therapy for physician-administered and patient self-administered agents under Medicare Part B and Part D.^[1]

Cancer, however, is likely to be far less forgiving.

This is just such a strategy. Step therapy is a type of prior authorization for drugs that gives patients access to more expensive treatments only if they have previously received and had a poor outcome on a lower-cost therapy. The American Society of Clinical Oncology (ASCO) immediately expressed opposition, with ASCO President Monica Bertagnolli, MD, arguing that “this not only delays patient access to proper treatments, it potentially leads to irreversible disease progression and other significant patient health risks.”^[2]

These concerns are well founded. Patients with elevated blood pressure or cholesterol levels have the opportunity to refine treatment options toward the most cost-efficient but effective antihypertensive and lipid-lowering agents, respectively, targeting outcomes over years or even decades. Cancer, however, is likely to be far less forgiving.

We don’t need to look far to find examples in which deferring treatments until later translates to inferior survival. A study from Europe and Canada known as TORCH randomly assigned patients with advanced non–small cell lung cancer (NSCLC), not selected by molecular markers or clinical factors, to receive either first-line cisplatin/gemcitabine or erlotinib, then switch to the other treatment upon progression.^[3] This study terminated early on the basis of a review of results by the Data Safety Monitoring Committee, which demonstrated a significantly worse progression-free survival (PFS) and overall survival (OS) in the recipients of first-line erlotinib (who we may assume were very unlikely to have a cancer harboring an EGFR mutation in this unselected broad population).

Notably, not only were PFS and OS significantly worse with the suboptimal treatment of erlotinib in an unselected patient population, but 41.7% of the patients assigned to first-line erlotinib did not receive second-line chemotherapy despite this being built into the protocol, “mostly because of worsening conditions or death.” And among those who were able to receive second-line cisplatin/gemcitabine, their objective response rate (ORR) was far less than half that obtained with this same regimen administered first-line (10.5% vs 25.6%).

With life-threatening lung cancer, at least, we learned that suboptimal treatment administered up front leads to fewer patients available for the best treatment later, and inferior outcomes among those who were able to receive it.

Several years later, at the 2018 ASCO annual meeting, we saw results from the Japanese randomized phase 3 NEJ009 trial of gefitinib alone versus gefitinib administered concurrently with carboplatin/pemetrexed chemotherapy as first-line treatment for patients with EGFR mutation-positive advanced NSCLC.^[4]Despite EGFR tyrosine kinase inhibitor (TKI) therapy being a current standard and platinum doublet chemotherapy—most commonly the same carboplatin/gemcitabine regimen employed on the concurrent arm—being the recommended subsequent treatment approach for recipients of gefitinib, the trial demonstrated that concurrent targeted therapy and chemotherapy led to a significantly longer PFS (median, 20.9 vs 11.2 months) and OS (median, 52.2 vs 38.8 months).

The only way to ensure that patients receive beneficial therapies is to “front-load” them.

The more recent NEJ009 recapitulates some of the themes of the TORCH trial: Patients who received an EGFR TKI alone were more likely to have more extensive spread of disease and a performance status of 2-4 at the start of chemotherapy than those patients in whom chemotherapy was moved into the first-line setting, while 25.6% of the recipients of first-line gefitinib alone failed to receive chemotherapy later.

Similarly, we’ve seen several trials now demonstrating a survival benefit with a combination of platinum doublet chemotherapy and immunotherapy, and in which crossover rates are typically less than 50%. We have also seen similar results in other settings such as prostate cancer, in which early administration of docetaxel^[5,6] or abiraterone/prednisone^[7] is associated with significantly longer OS than subsequent treatment.

Beyond these specific examples, the improvements in clinical outcomes in patients who receive maintenance therapy in many cancer settings are likely predicated largely on this proactive approach. It ensures that patients receive the benefit conferred by a therapy without the risk that a higher tumor burden and/or declining performance status will compromise the ability to deliver the same treatment later.

The converging evidence clearly demonstrates that the only way to ensure that patients receive therapies that are beneficial for them is to “front-load” them. This doesn’t mean that every patient should receive all of their effective treatments in combination as first-line treatment. However, we see a recurring theme: For patients with aggressive cancers, progression and the potential clinical decline that may accompany it are associated with both a lower probability of receiving effective therapies subsequently and also potentially suboptimal results even when these treatments are administered. For many cancers, this inevitable attrition with step therapy will save money at the cost of worse clinical outcomes for patients.

https://www.medscape.com/viewarticle/901307#vp_1

Google Ventures leads $45.4m investment in UK exosome biotech Evox

Google Ventures and US healthcare specialist Redmile were among a group of investors supporting a £35.5 million funding round for UK biotech Evox Therapeutics, which specialises in drugs delivered by biochemical parcels known as exosomes.

This second round of funding raises the equivalent of $45.4 million to support the advancement of Oxford-based Evox’s exosome-based therapeutics pipeline, including pushing several rare disease drugs towards the clinic, and further development of its exosome technology.

Exosomes are small cell-derived vesicles that are naturally released from cells and are thought to have a role in processes such as coagulation, intercellular signalling, and waste management.

But there is growing interest in their use in medicine, and Evox is engineering exosome to enable a variety of drugs to reach previously inaccessible tissues and compartments.

This includes allowing drugs to cross the blood brain barrier to the central nervous system, intracellular delivery of biologics, and delivery of RNA therapeutics.

Evox is developing its own pipeline of exosome therapeutics for rare and life-threatening diseases with unmet need.

The biotech has two large pharma collaborations, including one with Boehringer Ingelheim to investigate delivery of RNA using exosomes.

For the other, Evox is working with an unnamed top-10 pharma company on a project that uses exosome technology to deliver a small molecule drug to an undisclosed central nervous system target.

Evox is led by CEO Antonin de Fougerolles, previously chief scientific officer of Ablynx, which Sanofi bought earlier this year for $4.8 billion.

De Fougerolles said: “This additional funding will enable us to advance our pipeline of novel exosome-based therapeutics towards the clinic and allow continued expansion of our world-leading exosome platform.”

Aside from GV and Redmile, Cowen Healthcare Investments, Panacea Healthcare Venture, Borealis Ventures and a small number of private investors also joined the latest funding round.

Existing investors Oxford Sciences Innovation (OSI) and Oxford University also participated in the financing round, building on £10 million in seed financing from OSI.

Roche has already shown an interest in exosome technology this year, in July signing a potential billion-dollar deal with US biotech PureTech Health.

The project is focused on using a milk-derived exosome to allow delivery via the lymphatic system of antisense oligonucleotides developed by the Swiss pharma, possibly leading to novel therapies targeting immune cells.

https://pharmaphorum.com/news/google-ventures-leads-45-4m-investment-in-uk-exosome-biotech-evox/

UK biotech Azeria pioneers research into cancer target FOXA1

A new UK biotech, Azeria Therapeutics has started on a mission to develop breakthrough treatments for drug-resistant breast and prostate cancer, based around a new target known as FOXA1.

Azeria has been set up to develop breakthrough treatments for hormone-resistant disease and focuses on FOXA1, which has been proven to play a part in the way tumours form in the breast and prostate gland.

Dr Jason Carroll, founder and chief scientific officer, Azeria Therapeutics, said: “Oestrogen receptors are the driving and defining transcription factor in 75% of breast cancers. Our research has shown for the first time that DNA interactions and transcriptional potential of [oestrogen receptors] depend on the pioneer factor FOXA1, which plays an essential role in determining tumour growth and progression even when resistance to existing drugs has developed.

“Through the application of our unique insights into pioneer factors, we aim to identify inhibitors against this novel class of drug targets in cancer, which until now have been considered un-druggable.”

The news was welcomed by Dr Iain Foulkes, Cancer Research UK’s executive director of research and innovation, who said the organisation was committed to helping to translate the groundbreaking discoveries arising from its research base into urgently needed new treatments for those with cancer.

“Researchers are only just beginning to understand the mechanisms that underpin drug resistance in cancer and it’s exciting to see pioneering research by Cancer Research UK scientists being used to develop treatments to help tackle this widespread problem,” said Dr Foulkes.

Azeria Therapeutics was created by Sixth Element Capital and Cancer Research UK’s commercial partnerships team. The drug discovery company recently announced that it has successfully raised £4 million from the £70 million CRT Pioneer Fund, managed by UK-based fund manager Sixth Element Capital.

This investment will be used to build on the discoveries made by Azeria’s founder Dr Jason Carroll, a world-leading expert in pioneer factors in cancer who is based at the Cancer Research UK Cambridge Institute at the University of Cambridge.

https://pharmaphorum.com/news/uk-biotech-azeria-pioneers-research-into-cancer-target-foxa1/

BTG buys US vascular device firm Novate

UK-based BTG has announced it has bought US vascular device company Novate Medical, which is focused on the prevention of pulmonary embolism in patients at high risk of venous thromboembolic events.

BTG produces both drugs and medical devices for diseases such as cancer, vascular, and respiratory conditions, and acquired Novate on the basis of its Sentry, the first bioconvertible inferior vena cava filter, which has been granted regulatory clearance in the US.

The filter is placed in the vena cava to prevent life-threatening blood clots in the lungs.

Sentry’s 12-month clinical trial data demonstrated no new symptomatic pulmonary emboli and no evidence of device migration, tilt, fracture, perforation or embolisation, complications which have been associated with some other inferior vena cava (IVC) filters.

The unique bioconversion feature eliminates the need for an additional interventional procedure to retrieve the device.

BTG paid $20m in cash to acquire Novate and may be required to pay additional cash considerations up to $130m if certain commercial and sales-related milestones are met.

The transaction is expected to be accretive to adjusted EPS from the second full year of ownership.

“This bolt-on acquisition further enhances BTG’s strength in the vascular space,” said Louise Makin, BTG’s CEO. “Novate’s unique IVC filter offers our existing customers a highly complementary product in the management of PE.”

BTG suffered a setback early last month when the FDA rejected a filing for pre-market approval for its Elevair Endobronchial Coil System for people with severe emphysema.

The decision was not a surprise though, as in June a panel of FDA advisers voted against approving Elevair.

The FDA is not bound to follow the recommendations of its expert advisers, but it usually does.

BTG said at the time it is reviewing its options and will provide an update in due course.

https://pharmaphorum.com/news/btg-buys-us-vascular-device-firm-novate/