Thursday, January 17, 2019
Celsion announces results from Phase 1 TARDOX trial published
Celsion announced that results from the Phase I TARDOX trial of ThermoDox conducted at the University of Oxford, United Kingdom, were published in the peer-reviewed journal, Radiology. The TARDOX trial evaluated the safety and efficacy of ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin, along with focused ultrasound for the treatment of liver cancer. The article included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox plus targeted, non-invasive hyperthermic ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific modeling. A lysolipid thermally sensitive liposome encapsulating the chemotherapy agent, doxorubicin, ThermoDox is designed to release targeted levels of doxorubicin into and around liver tumors with heat activation. The Phase I TARDOX study demonstrated that focused ultrasound exposure with ThermoDox resulted in increased chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10 patients in the study. The Phase I TARDOX study evaluated patients with inoperable primary or secondary liver tumors who had previously received chemotherapy. In this trial, 10 patients received a single intravenous dose of 50 mg/m2 of ThermoDox, and ultrasonic heating of target tumors was monitored in six participants using a minimally invasive temperature sensor, while four patients were treated without real-time thermometry. Safety was assessed by analysis of magnetic resonance imaging, or MRI, and biopsy specimens for evidence of thermal ablation, as well as adverse event monitoring. There was no evidence of focused ultrasound-related adverse effects, including thermal ablation. Numerous studies have demonstrated that focused ultrasound can be used to generate mild heating to facilitate the release of drug cargoes from thermosensitive liposomes, or TSLs. The company believes the TARDOX study is the world’s first Phase I clinical trial aimed at evaluating the effect of doxorubicin released from TSLs after focused ultrasound-induced mild hyperthermia. The study presents a model for predicting the focused ultrasound treatment parameters needed to attain mild hyperthermia and facilitate doxorubicin release from TSLs. This model may improve the current clinical use of hyperthermia by providing an alternative strategy for treatment planning based on a thermal model rather than actual thermometry, which is more invasive. For all participants, CT images were used with the patient-specific hyperthermia model in order to define focused ultrasound treatment plans. Feasibility was assessed by comparing model-prescribed focused ultrasound powers to those implemented for treatment. Celsion believes this is a meaningful initial demonstration of the model providing accurate, successful treatment parameters. In addition, these observations support the potential for non-invasive hyperthermic ultrasound to expand the use of ThermoDox to the treatment of other types of cancer.
https://thefly.com/landingPageNews.php?id=2850273
Teladoc catalysts give reason to own stock now, says Jefferies
Jefferies analyst Sean Dodge says his firm’s updated market share analysis continues to show Teladoc as the dominant vendor. SimilarWeb data points to BetterHelp usage down quarter-over-quarter in November but stabilizing in December and up in January, Dodge tells investors in a research note. There are “multiple upcoming catalysts, giving investors a reason to own the stock now,” says the analyst. He points out Teladoc shares are still down over 30% from their late-September highs. Dodge keeps a Buy rating on the stock with a $95 price target, which represents 57% upside potential.
https://thefly.com/landingPageNews.php?id=2850275
Mednax assumed with a Hold at Jefferies
Jefferies analyst Jason Plagman assumed coverage of Mednax with a Hold rating and lowered his price target for the shares to $39 from $44. While the analyst expects stable to slightly improving organic growth and margin trends in 2019, he believes slow birth trends and payor mix shifts are likely to continue to pressure MD’s business model until physician comp is restructured. The valuation is “depressed” but the stock lacks near-term catalysts, Plagman tells investors in a research note.
https://thefly.com/landingPageNews.php?id=2850281
Wednesday, January 16, 2019
FDA Accepts Genentech Application for Tecentriq Plus Chemo for Lung Cancer
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq®(atezolizumab) in combination with Abraxane® (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations. The FDA is expected to make a decision on approval by September 2, 2019.
“We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”
This sBLA is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous NSCLC.
The FDA recently approved Tecentriq in combination with Avastin®, paclitaxel and carboplatin (chemotherapy) for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.
Japan Tobacco ratchets up smokeless war with new products
Japan Tobacco Inc on Thursday unveiled two “heat-not-burn” products, as it races against market leader Philip Morris International Inc for a larger share of the vaping space with conventional cigarettes steadily falling out of favour.
Despite commanding 60 percent of the local cigarette market, Japan Tobacco has been caught on the wrong side of the rising popularity of heat-not-burn (HNB) alternatives and has lagged in the category in its own backyard versus the Marlboro maker.
Philip Morris in 2014 started selling its IQOS HNB device in Japan, which has emerged as a fertile test ground for vaping products since e-cigarettes using nicotine-laced liquid are not allowed under the country’s pharmaceutical regulation.
Japan Tobacco managed to roll out its vaping product, Ploom TECH, only by 2017 after repeated production delays. And even then, some users have complained about its weak taste.
It is now planning to start selling Ploom TECH+ and Ploom S in Japan from Jan. 29 to tap into the HNB market that continues to grow, albeit at a slower pace.
Ploom TECH+ is priced at 4,980 yen, while Ploom S will sell for 7,980 yen – same as IQOS’ cheapest version.
“We are aiming for the No. 1 position,” said Mutsuo Iwai, head of Japan Tobacco’s domestic tobacco business.
“Japan is the biggest HNB market, a success in Japan will lead to a success globally.”
PROMISING BETTER TASTE
IQOS had a 71.8 percent share of Japan’s HNB market last year, while British American Tobacco glo had 20.1 percent and Ploom TECH’s 8.1 percent, Nomura estimates.
HNB products accounted for 20.9 percent of Japan’s tobacco market in 2018, versus 12 percent a year ago, according to an estimate by Satoshi Fujiwara, an analyst at Nomura.
Japan Tobacco has said it expects vaping products to account for 30 percent of the domestic tobacco market by end-2020 and will spend heavily in the field as cigarette sales drop.
Japan Tobacco’s conventional cigarette sales volume in the country fell 11.4 percent over Jan-Nov last year.
The former state monopoly, still one-third owned by the government, has been scrambling to launch new HNB products after many smokers found the taste of its current one weak.
Unlike IQOS and glo, Ploom TECH does not directly heat tobacco rolls. Instead, it generates vapour that goes through a tobacco-packed capsule, emitting far less smell but, according to users, less potent than rival products.
This has partly hurt sales, with the firm in October cutting its Ploom TECH capsules sales forecast by 30 percent for 2018.
Iwai said the new products were Japan Tobacco’s answer to user complaints as they are designed to give a stronger taste.
“We believe we can lure back those who tried Ploom TECH but stopped using it,” he said.
Boosting social functioning treatments for people with autism
A new study indicates the prevalence rates of autism spectrum disorder (ASD) have now grown to 1 in 40, a jump from the rate of 1 in 65 published just two years ago. Indeed, ASD is now the fastest growing neurodevelopmental disorder in the U.S.
Social deficits are core to a diagnosis of ASD. For people who have typical or above cognitive functioning, sometimes referred to as “high-functioning” ASD, struggles navigating social interactions can result in underemployment, difficulty living independently, and a lack of meaningful relationships that can lead to isolation and depression.
Treatments that address social deficits are painfully slow and tedious to implement, resulting in increased suffering and overall quality of life concerns for people with ASD. These treatments are often delivered by speech-language pathologists (SLPs) who specialize in social communication disorders. Joan Esse Wilson is an SLP who has been working for over a decade with people with ASD, after receiving her master’s degree from The University of New Mexico (UNM) Department of Speech and Hearing Sciences.
“Watching people with ASD struggle with life-impacting social deficits motivated me to apply to a doctoral program where I could research more efficient and effective ways to deliver treatments,” Esse Wilson reports.
Then she heard about transcranial direct current stimulation(tDCS), a form of noninvasive brain stimulation, and learned that researchers at UNM were completing tDCS studies demonstrating accelerated and/or enhanced performance on a variety of tasks.
Serendipitously, Esse Wilson attended an event at the UNM Department of Psychology shortly after her admission to the doctoral program for the Speech and Hearing Sciences Concentration in the UNM Department of Linguistics. It was then that she met Claudia Tesche, a Professor in the Department of Psychology and director of the Transcranial Stimulation Lab. The meeting ultimately resulted in the two collaborating on research that has yielded two recently published papers.
“There really is no other work like this being completed anywhere,” Tesche said. “It’s groundbreaking, and we’ve seen some promising preliminary results for people with ASD from pairing tDCS with treatments for social functioning, emotion verbal fluency and empathy.”
“This research has been an opportunity to collaborate with people from a wide variety of UNM departments, including Psychology, Linguistics, Speech and Hearing Sciences, Psychiatry and Behavioral Sciences, and the College of Education, as well as from Sandia National Laboratory,” Esse Wilson adds. “Most importantly, I’ve received feedback from people with ASD that this research gives them hope.”
This study is ongoing and has recently been approved to include adolescents ages 15 years and over.
U.S. Cancer Rates Have Fallen for at Least 25 Years
The American Cancer Society released a report on January 8 by Rebecca Siegel showing that the cancer rates in the U.S. have been falling for at least 25 years.
Although that is good news, cancer is the second-most common cause of death in the U.S., with more than 1.7 million new cancer cases each year and more than 600,000 cancer deaths. The report notes that one of the biggest factors in decreased cancer rates are lower tobacco smoking rates. Improvements in early detection and treatment are also a factor.
Unfortunately, obesity-related cancer deaths are increasing, and deaths caused by prostate cancer have leveled out—they were dropping.
Cancer death rates increased in the U.S. until the early 1990s, the report notes. It has dropped ever since, decreasing 27 percent between 1991 and 2016. As mentioned above, this is related to smoking. Lung cancer rates have dropped by almost 50 percent among men since 1991. Siegel notes that it is a delayed effect from a drop in smoking that began in the 1960s.
Prostate cancer is the second leading cause of cancer death in men. For twenty years prostate cancer death rates dropped. From 2013 to 2016, however, those rates flattened. Researchers and physicians wonder if that stagnation is related to a 2011 decision by the U.S. Preventive Services Task Force to stop recommending routine prostate-specific antigen (PSA) blood testing for men.
Cancer deaths related to obesity include thyroid, pancreatic and uterine cancer, as well as liver cancer. Liver cancer deaths increased since the 1970s but were associated with hepatitis C (HCV) infections. HCV infection is decreasing, largely due to the effectiveness of various HCV drugs like Gilead Sciences’ Harvoni and Sovaldi.
However, with that drop in HCV-related cancers, obesity is linked to about a third of liver cancer deaths, a bigger factor than hepatitis. Siegel is concerned that because risk factors do not necessarily show up for decades, these new links to obesity and cancer “may just be … the tip of the iceberg in terms of the effect of the obesity epidemic on cancer.”
It’s important to note that the biopharmaceutical industry has played an important role in decreasing cancer rates. The entire field of immuno-oncology, which has really come to fruition in the last few years, has revolutionized the treatment for certain types of cancers, and drugs are increasingly targeting specific patient populations.
Just a few examples of 2018 approvals include Array BioPharma’s June 2018 approval for Braftovi and Mektovi for unresectable or metastatic melanoma with a BRAFV600E or BRAFV600k mutation; Regeneron Pharmaceuticals’ Libtayo for cutaneous squamous cell carcinoma, approved in September 2018; Pfizer’s Talzenna in October 2018 for deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer; Pfizer’s Daurismo in November 2018 for newly-diagnosed acute myeloid leukemia in adults 75 years or older; Janssen’s Erleada for prostate cancer in February 2018; AstraZeneca’s Lumoxiti for relapsed or refractory hairy cell leukemia, and many others.
From November 2016 through October 2017, the U.S. Food and Drug Administration (FDA)approved 18 new cancer therapies and 13 new uses of cancer therapies. And 2017 was an historic year, when the first T-cell and gene therapy for cancer was approved. The American Society of Clinical Oncology notes, “Research results on other immunotherapies and targeted therapies released in 2017 have changed the treatment paradigms for lung, prostate, and bladder cancer.”
And although this latest report is good news, more than 14 million people worldwide will be diagnosed with cancer, with almost 9 million death a year, or 22,000 cancer deaths daily. And it’s expected to increase, hitting 21 million cancer patients worldwide and 13 million annual deaths by 2030.
One of the things the new American Cancer Society report discusses are disparities in cancer deaths related to income, race and gender. Darrell Gray, deputy director of Ohio State University’s Center for Cancer Health Equity, noted, “We’ve known for some time that race is a surrogate” for other factors, such as poverty and access to healthcare, as well as paying for care.
The ASCO report states, “Significant cancer health disparities continue to exist in certain populations. Race, ethnicity, socioeconomic status, and geography all affect patient health outcomes, and racial and ethnic minorities and individuals of lower socioeconomic status experience worse cancer outcomes.”
Age is also a significant factor. According to ASCO, more than 60 percent of cancer diagnoses in the U.S. are in people 65 years or older. Yet older adults are underrepresented in clinical trials. In November 2017, ASCO and the FDA held a workshop to evaluate ASCO’s recommendations to improve the evidence base for treating older adults, and ASCO continues to encourage federal agencies and the cancer research community to increase enrollment of older adults in clinical trials.
Siegel concludes the ACS report, “Although the racial gap in cancer mortality is slowly narrowing, socioeconomic inequalities are widening, with residents of the poorest counties experiencing an increasingly disproportionate burden of the most preventable cancer. These counties are low-hanging fruit for locally focused cancer control efforts, including increased access to basic health care and interventions for smoking cessation, healthy living, and cancer screening programs. A broader application of existing cancer control knowledge with an emphasis on disadvantaged groups would undoubtedly accelerate progress against cancer.”
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