Inovio launches Ph1 study of Hep C vaccine

Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine against hepatitis C infection.

The companies plan to recruit 24 study participants to evaluate Inovio’s GLS-6150 candidate. Participants will include people who have a sustained virologic response following treatment for Hep. C, as well as healthy controls. They are slated to receive one of two doses of vaccine, administered intra-dermally and followed by electroporation with Inovio’s Cellectra device.

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Pixium Vision’s novel Prima chip helps patients see the light

Pixium Vision said today that its Prima miniature wireless photovoltaic sub-retinal implant has been activated in the first five patients.

The patients all have severe vision loss from atrophic dry age-related macular degeneration. They are enrolled in a three-year clinical study in France to evaluate the safety and function of the Prima chip in eliciting visual light perception, the company said in a statement. All five reported seeing useful light patterns in areas where they had had no remaining light perception. The current study patients will be taught how to interpret their new artificial central macular perception.

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Novocure inks collaboration for pivotal pancreatic cancer trial

Novocure (NSDQ:NVCR) and US Oncology Research said today that the groups are collaborating on a phase III pivotal trial designed to test Novocure’s Tumor Treating Fields with nab-paclitaxel and gemcitabine in patients with unresectable locally advanced pancreatic cancer.

Using a network of community-based oncology practices, US Oncology Research plans to open 10 clinical trial sites to enroll patients in Novocure’s Panova-3 trial, the companies reported.

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Masimo touts study exploring pulse oximetry pre-screening for OSA in children with down syndrome

Masimo (NSDQ:MASI) yesterday released results from a study exploring home pulse oximetry monitoring’s ability to serve as an initial screening method to determine which children with Down syndrome should be recommended to undergo sleep studies to diagnose obstructive sleep apnea.

The Irvine, Calif.-based company said that children with Down syndrome are at high risk of obstructive sleep apnea, which can only be reliably diagnosed using multichannel sleep studies, which are expensive and time-consuming.

A total of 161 children with DS between 0.5 and 6 years old were selected for the trial, 25 of which were separately diagnosed with OSA. Patients were monitored overnight using Masimo’s Radical-7 Pulse CO-Oximeters with sensors placed on the great toe, Masimo said.

Measurements recorded in the trial include total artifact-free time analyzed, mean oxygen saturation, minimum SpO2, 3% oxyhemoglobin desaturation index, Delta 12s index and the number of minutes per hour that SpO2 was below 90%.

Researchers, who were blinded to which subjects had received an OSA diagnosis, found that the use of pulse oximetry monitoring reduce the amount of children with DS who are screened for OSA by approximately half, according to Masimo’s release.

Investigators noted that the findings only applied to Masimo oximeters, and could not be generalized to other devices, and that the use of a retrospective clinical dataset and anonymous data “limits our information on the wider sampling frame, demographic and clinical characteristics of these children.”

Earlier this month, Masimo posted second quarter earnings that beat expectations on Wall Street and raised its guidance for the remaining fiscal year.

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Conavi Medical touts first investigational use of Novasight hybrid IVUS-OCT system

Conavi Medical yesterday announced the first use of its Novasight hybrid system designed for imaging coronary arteries through both intravascular ultrasound and optical coherence tomography as part of an investigational trial.

The system was used in its first procedure under a Health Canada Investigational Testing Authorization at Hamilton General Hospital by study co-investigators Dr. Tej Sheth and Natalia Echeverri, the company said.

“The Novasight Hybrid imaging catheter is a deliverable imaging system that is able to rapidly and simultaneously acquire co-registered IVUS and OCT images. In this study, we are collecting the first human images with this novel imaging system to confirm the functionality of the technology in the clinical environment and to help inform future studies. We have been able to identify some early examples of the synergies between these two modalities in our clinical experience so far. Ultimately, hybrid IVUS/OCT imaging has the potential to overcome the limitations of IVUS or OCT alone in accurately characterizing atherosclerotic tissue and in guiding coronary interventions,” Dr. Sheth said in a prepared statement.

Conavi Medical said the technology behind the Novasight system was developed by Toronto’s Sunnybrook Research Institute in Toronto, and that Conavi is commercializing the system.

“The purported advantages of the synergistic information that IVUS and OCT can provide have been highly anticipated in the interventional cardiology community. These cases performed in Hamilton represent the first worldwide clinical use of any system that combines IVUS with OCT on a single catheter. In an era of personalized and precision medicine, we believe that the ability to collect comprehensive imaging data in patients with coronary artery disease provides an important opportunity to generate improved clinical decision-making capabilities for these patients in the future,” prez & CEO Dr. Brian Courtney said in a press release.

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Viveve wins FDA nod to continue Viveve II trial

Viveve (NSDQ:VIVE) said yesterday it won FDA clearance to continue enrollment in its Viveve II trial exploring the safety and efficacy of its Viveve system for improving sexual function in women following vaginal childbirth.

The approval came based off sufficient evidence to support continued enrollment and a lack of subject protection concerns which would preclude continuation, the Englewood, Colo.-based company said.

The Viveve II study is a randomized, double-blinded, sham-controlled trial which looks to enroll 250 patients at 25 sites across the US and Canada. The FDA requested a staged approach to enrollment initially with a safety review completed based on one-month follow-up data for an initial 25 subjects.

Viveve said that the FDA requested a second safety review will will be collected from an additional 25 subjects out to one month, and from the first 50 subjects at three months. During the second safety review, enrollment in the trial will continue up to 100 subjects.

The trial’s primary efficacy endpoint is intended to be mean change from baseline as measured by the Female Sexual Function Index at one year, with safety assessed over the same period. Secondary and exploratory endpoints in the trial include FSFI domain score improvements for desire, lubrication, orgasm, arousal, satisfaction and pain.

“This clearance to continue enrollment represents a major step forward in the progression of the Viveve II trial and for women seeking an improvement in sexual function following child birth. Following FDA review of the second stage of safety data, and approval of an IDE supplement to expand the study, Viveve plans to continue enrollment up to 250 patients,” CEO Scott Durbin said in a press release.

In June, Viveve said that it inked a settlement and licensing agreement with Thermigen and associated defendants to resolve a patent litigation claiming Thermigen improperly used Viveve intellectual property with its ThermiVa system.

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Pulse Biosciences’ nano-pulse stimulation tested in skin cancer patients

Pulse Biosciences, Inc. (Nasdaq:PLSE) has begun a clinical study to evaluate nano-pulse stimulation (NPS) platform in a common skin cancer, basal cell carcinoma (BCC).

NPS is a non-thermal therapy that uses ultra-short, nanosecond-pulsed electric fields that directly affect and disrupt intracellular structures. It has been shown to induce immunogenic cell death in pre-clinical cancer models, according to the company.

Study participants will be treated with NPS prior to resection of the BCC lesion, which is the standard of care for such lesions. Post-resection tissue samples will be assessed for the elimination of the lesion in the NPS treatment zone and for biomarkers indicating an immune response to the NPS-treated lesions.

The Hayward, Calif. startup withdrew the FDA 510(k) application for its PulseTx NPS system on September 11, 2017, saying it failed to meet a deadline for submitting requested information to the agency. The company has said it intends to refile.

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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.

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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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