Vaccine maker PaxVax tackles the unmet need posed by chikungunya virus

Transmitted by the same mosquitoes that spread Zika virus and dengue fever, the chikungunya virus is named for an African word meaning “to become contorted.” People infected with the alphavirus are afflicted with lasting joint pain that causes their backs to hunch over, according to the World Health Organization.

The virus, which has cropped up in Africa, Asia, Europe and the Caribbean, has no vaccine. Instead, the Centers for Disease Control & Prevention recommends that people traveling to countries with chikungunya virus use insect repellent and wear long sleeves and pants.

But Nima Farzan thinks a vaccine in his company’s pipeline could help change that.

Get the full story at our sister site, Drug Delivery Business News.

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Siga Technologies touts pivotal data for oral smallpox therapy

Siga Technologies (NSDQ:SIGA) said today that data from a pivotal human safety study and animal efficacy studies of its oral smallpox therapy were published in the New England Journal of Medicine.

Data from the studies support the efficacy and favorable safety profile of Tpoxx, an oral formulation of tecovirimat.

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FDA approves ReCor Medical’s pivotal ultrasound denervation study

ReCor Medical said this week that the FDA approved a new pivotal study of the company’s Paradise ultrasound denervation system for the treatment of hypertension.

The Palo Alto, Calif.-based company reported that its trial, Radiance-II, will be a randomized, sham-controlled study in patients with moderate hypertension. The study is designed to demonstrate the Paradise system’s safety and ability to lower blood pressure.

ReCor plans to start enrolling patients for Radiance-II in October.

“We have had a very constructive dialog with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future FDA review for PMA approval,” Leslie Coleman, VP of regulatory & medical affairs, said in prepared remarks. “At the time of PMA submission we plan to have 4 independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages  of hypertension – our Solo, Trio, Require, and Radiance-II studies – approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”

“Our steering committee and medical advisors have been instrumental in the design of the global Radiance clinical program – including the Radiance-II pivotal study – for the US, EuropeJapan and Korea,” Helen Reeve-Stoffer, VP of clinical affairs, added. “Given the recent positive Solo results, and subsequently the numerous review articles in medical journals, we recognize the potential impact the Paradise System may have in the treatment of hypertension for millions of patients world-wide. Accordingly, ReCor is committed to conduct rigorous, randomized, controlled studies to demonstrate the safety and efficacy of the Paradise system to lower blood pressure, thus helping physicians to evaluate how, in whom, and when to use Paradise for the treatment of hypertension.”

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Silk Road Medical touts TCAR study data

Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease.

Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston.

The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system, and is intended to treat blockages in the carotid artery that are at risk of causing a stroke.

Results from a two-year study which compared outcomes from 1,182 patients who received treatment with the TCAR procedure to 10,797 patients who received carotid endarterectomy indicated comparable rates of in-hospital stroke or death between the two at 1.6% versus 1.4%, respectively.

Data also indicated lower rates of acute cranial nerve injury for TCAR at 0.6% versus a 1.8% rate in CEA patients, shorter operative times at 78 minutes and 111 minutes, respectively, and shorter hospital stays for TCAR patients despite increased age and sickness factors versus the CEA cohort.

Results from a separate study comparing TCAR with CEA indicated similar results, with 30-day stroke rates of 1% in TCAR versus 1.1% in CEA. Acute and six-month cranial nerve injury rates were also shown to be smaller in the TCAR cohort than CEA.

“Our overall findings showed that while patients receiving TCAR were sicker and more likely to be symptomatic with a higher degree of stenosis, the stroke and death rate compared to CEA was the same. With TCAR, there were significantly lower cranial nerve injuries, less time spent in the operating room and fewer patients with a prolonged length of stay. I believe that clinicians should more widely adopt the TCAR technology as it has demonstrated both safety and efficacy and is an excellent alternative to CEA,” study presenter Dr. Marc Schermerhorn of Beth Israel Deaconess Medical Center said in a press release.

An interim update on the company’s Roadster 2 post-market study trial indicated a 30-day stroke rate of 0.6% and stroke or death rate of 0.9% with 470 patients of an expected 600 patients enrolled.

“The large body of real-world data presented at VAM18 demonstrates that TCAR can achieve neuroprotection similar to CEA despite being performed in sicker, more frail and ‘at-risk’ patients. These results reiterate the compelling data previously published in the Roadster pivotal trial. Carotid endarterectomy has been the gold standard for 65 years, but with the growing body of evidence, the medical community is showing that TCAR is fulfilling the promise of a less invasive, more efficient, and more patient friendly procedure,” prez & CEO Erica Rogers said in a prepared statement.

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Sage Therapeutics’ chief scientist on discovering drugs and taking risks

When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk.

But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY) significantly downsized their neuroscience units.

Robichaud couldn’t shake the feeling that the industry was on the verge of walking away from what is at the very core of drug discovery.

Get the full story at our sister site, Drug Delivery Business News.

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ReWalk Robotics expands ReStore soft exo-suit trial

ReWalk Robotics (NSDQ:RWLK) said today that it plans to expand the clinical study of its ReStore soft exo-suit device to five U.S. research centers.

The Marlborough, Mass.-based company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.

Enrollment for the company’s multi-center study is ongoing. The five centers involved in the trial include the Shirley Ryan AbilityLab, Spaulding Rehabilitation Hospital, the MossRehab Stroke and Neurological Disease Center, TIRR Memorial Hermann and the Kessler Foundation.

“We expect that the expansion of our clinical study to these renowned research organizations will bring the ReStore exo-suit closer to CE and FDA clearance,” CEO Larry Jasinski said in prepared remarks. ”The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the U.S. with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market.”

“The ReWalk ReStore is an unobtrusive wearable robotic technology that can seamlessly interact with and enhance everyday clinical care, allowing stroke patients to walk effectively and efficiently,” lead investigator Arun Jayaraman added. 

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Endologix reports 1-year data from Ovation registry

Endologix (NSDQ:ELGX) this week touted 1-year results from its Lucy registry – a study that prospectively assessed endovascular aneurysm repair outcomes in women compared to men.

The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system compared to other EVAR systems.

The study enrolled 225 people, 76 women in the treatment group and 149 men in the control group, and the primary endpoint was the 30-day major adverse event rate. Secondary endpoints included serious and non-serious adverse events after one year.

Endologix reported that despite having more complex anatomy, women experienced similar outcomes to men following treatment with the Ovation device, including 100% freedom from AAA-related mortality compared to 98.6% in men. Freedom from reintervention for Type 1a endoleak was 98.6% in women and 97.9% in men, the company reported, and freedom from rupture and conversion was 100% across both groups.

Freedom from all device-related reintervention was 97.2% in both men and women, Endologix noted.

“Women have specific anatomical challenges in iliac access and proximal aortic neck morphology and have historically had worse outcomes from EVAR than men. The results of the LUCY study suggest that the unique features of the low-profile Ovation system may overcome these challenges and achieve similar outcomes in men and women,” Dr. Jennifer Ash, of the Christie Clinic Vein and Vascular Center, said in prepared remarks.

“We are excited to have completed follow-up on the Lucy study and are pleased that the one-year results suggest, for the first time in a prospective study, that female AAA patients can be treated with EVAR as effectively as men, when using the Ovation System. Lucy’s evidence provides physicians with new information to confidently engage female patients with prospectively derived outcomes previously realized only by male patients,” Endologix CEO John Onopchenko added.

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PQ Bypass touts 1-year Detour study data

PQ Bypass touted 12-month data today from a trial evaluating its Detour percutaneous femoropopliteal bypass system.

Results from the Detour I trial showed “promising 12-month durability” for patients with extremely long blockages in the superficial femoral artery, the company reported.

The study included lesions that were longer and more complex than typically seen in SFA trials: the average lesion length was 37 cm, PQ Bypass said.

“The lesions treated in Detour I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dr. Dainis Krieviņš, vascular surgeon & director of the Institute of Research at Pauls Stradins Clinical University Hospital. “Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average Detour lesion and fail approximately 40% of the time by the 12-month milestone. This truly highlights the need for the minimally invasive Detour procedure for long, complex SFA lesions.”

PQ Bypass’ percutaneous femoropopliteal bypass procedure uses the company’s stent grafts to make a path that sends blood around the blocked part of the artery, restoring blood flow to a patient’s lower leg and foot.

The company’s Detour I trial enrolled 77 patients and treated 81 lesions. Primary patency at 12 months in all lesions was 73%, while primary-assisted patency was 80%. Secondary patency was met in 94% of the study’s participants.

PQ Bypass also noted that the trial had 100% freedom of amputation, 99% freedom from acute limb ischemia and Rutherford improvement of greater than or equal to two classes in 90% of patients.

“These results represent exciting promise for patients with long, complex SFA lesions, a growing, yet severely underserved population,” Heather Simonsen, VP of global therapy development, said. “By routing blood around the disease, rather than forcing a way through it, the Detour System is designed to treat extremely long lesions that are not well-addressed by current endovascular devices.”

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Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding

Data from a collaboration between Ferring PharmaceuticalsMerck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth.

Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent the deadly condition. But oxytocin has to be stored and transported at 2 – 8°C, which is not always possible in countries where adequate storage and distribution resources are scarce.

Get the full story at our sister site, Drug Delivery Business News.

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CEL-SCI wins $2.9M in CRO legal battle

Score one for the little guy.

After a four-year legal battle, immunotherapy maker CEL-SCI Corporation has won the first-ever breach-of-contract case against a contract research organization, or CRO.

In a final and binding decision, an arbitrator concluded that CRO inVentiv knowingly and fraudulently misled CEL-SCI with regard to enrollment projections for a clinical trial of CEL-SCI’s immunotherapy treatment for head and neck cancer. The arbitrator also said inVentiv used “scorched earth” litigation tactics and awarded CEL-SCI $2.9 million in damages, according to a statement from Vienna, Va.-based CEL-SCI.

The arbitrator denied inVentiv all but one of its counterclaims against CEL-SCI, which was for $429,649 for certain unpaid invoices.

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