Doctors using crowdsourcing tool to aid diagnosis – study

A new study has found that physicians around the world are increasingly using doctors-only, peer-to-peer crowdsourcing to get help with diagnosing patients.

Medical diagnostic errors are a serious and costly strain on healthcare systems worldwide, for which patients carry the ultimate risk of harm. The problem highlights a need for strong physician networks to enable specialist consultations and the discussion of potential diagnoses and treatments.

A new study published in Nature Digital Medicine demonstrates the significant global reach and broad appeal of an online, crowdsourced consultation platform for physicians in search of diagnostic and therapeutic input.

In their study, Scripps Research scientists examined the profiles and usage characteristics of over 37,000 active users of Medscape Consult, a free, physician-to-physician virtual consultation forum available via Medscape, one of the largest global online communities of physicians and healthcare providers, during a two-year period between November 2015 and October 2017.

They found that physicians from every continent used the platform and that more than 90% of cases posted by the physician-users received responses from other physicians within a short period, demonstrating the potential of such platforms for leveraging expert medical knowledge for patient care around the world.

The usage data indicated that younger physicians were responsible for posting the majority of patient cases, while users who had been in medical practice longer contributed more responses.

Although physicians from internal medicine made up the largest population of users, representing over a quarter of the total, there were a wide variety of medical and surgical subspecialties active on the platform during the study period.

Study author Evan Muse, a digital medicine researcher at Scripps Research Translational Institute and a cardiologist at Scripps Clinic, said: “Digital technologies are changing the way medical information is gathered and exchanged.

“Our analysis of the Medscape Consult platform shows that physicians of all ages and medical subspecialties from across the globe are utilising it as a tool to discuss potential diagnoses and obtain second opinions.”

https://pharmaphorum.com/news/doctors-using-crowdsourcing-tool-to-aid-diagnosis-study/

Intuitive Surgical upgraded to Overweight from Neutral at Piper Jaffray

https://thefly.com/landingPageNews.php?id=2801841

Updated NCCN guides stress advantage of Genomic Health Oncotype DX test

Genomic Health announced that its Oncotype DX Breast Recurrence Score test has been categorized as the only “preferred” test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer by the National Comprehensive Cancer Network,NCCN, in its 2018 guidelines for invasive breast cancer chemotherapy treatment. The only test elevated to “strongly consider” guideline inclusion with level 1 evidence, Oncotype DX continues to be distinguished as the only genomic test predictive of chemotherapy benefit. NCCN’s guidelines update follows the recent publication of results of Trial Assigning IndividuaLized Options for Treatment , or TAILORx, led by ECOG-ACRIN Research Group. The largest adjuvant treatment breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries. The study results, published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving. Additionally, the NCCN guidelines elevated Oncotype DX into the algorithm for chemotherapy treatment of patients with micrometastases and one to three positive lymph nodes.
https://thefly.com/landingPageNews.php?id=2801869

ObsEva presents clinical data from Phase 3 trial of Nolasiban

ObsEva announced that IMPLANT 2 Phase 3 clinical data of its novel, oral, oxytocin receptor antagonist, nolasiban, in patients undergoing IVF were presented at the 74th annual meeting of the American Society of Reproductive Medicine, taking place in Denver, Colorado, October 6-10, 2018. In the oral presentation entitled “A Placebo-controlled, Randomized, Double Blind, Phase 3 Study Assessing Ongoing Pregnancy Rates After Single Oral Administration of a Novel Oxytocin Receptor Antagonist, Nolasiban, Prior to Single Embryo Transfer” the primary endpoint results of the IMPLANT 2 trial showed an improvement in the rate of ongoing pregnancy 10 weeks post either Day 3 or Day 5 ET, with nolasiban treatment vs. placebo, 35.6% vs. 28.5%, a 25% increase. For women undergoing Day 5 ET, nolasiban resulted in an ongoing pregnancy rate of 45.9% vs. 34.7% for placebo, a 32% increase. Importantly, the tolerability and safety profile of nolasiban has been observed to be comparable to placebo, with no increase in serious adverse events, in ectopic pregnancy, nor in congenital birth defects. In addition, a secondary endpoint of miscarriage rate from weeks 2 to 24 of gestation showed a favourable impact from nolasiban treatment suggesting a reduced miscarriage rate following nolasiban treatment compared to placebo.
https://thefly.com/landingPageNews.php?id=2801871

Sangamo initiated at Guggenheim

Sangamo initiated with a Buy at Guggenheim. Guggenheim analyst Whitney Ijem initiated Sangamo with a Buy rating and $18 price target, citing the company’s diversified tech platform, pipeline, progress on partnerships, and the new TxCell acquisition.
https://thefly.com/landingPageNews.php?id=2801893

Novartis: Crizanlizumab upped number of patients free of sickle cell pain crises

Results from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab, a humanized anti-P-selectin monoclonal antibody being investigated for the treatment of sickle cell disease (SCD), have been published in the American Journal of Hematology. The analysis showed that more patients treated with crizanlizumab did not experience a vaso-occlusive crisis (VOC) vs those treated with placebo (35.8% vs 16.9%), specifically patients with a history of 2-10 VOCs in the previous year.

VOCs are a painful complication of SCD and the main reason why patients seek medical care in hospitals1,2. VOCs, which are triggered by multi-cell adhesion, are associated with increased morbidity and mortality, and can result in stroke, as well as organ damage or failure3,4. Currently, treatment options for VOCs are limited5.

“The unpredictable, intense painful crises that patients with sickle cell disease experience are the hallmark of the disease and the primary cause of hospitalizations in this patient population,” said Abdullah Kutlar, MD, Director, Sickle Cell Center at the Medical College of Georgia, Augusta University, Augusta, Georgia, and primary author of the SUSTAIN analysis. “I am encouraged that results from this post hoc analysis of SUSTAIN study data found that crizanlizumab could substantially delay or prevent these crises, which also may mean less organ damage in the long run.”

The post hoc analysis reviewed 52-week results from 132 patients, including 67 treated with crizanlizumab 5 mg/kg and 65 who received placebo. All evaluated patients had a history of at least 2 VOCs in the year prior to the study, with 62.9% (n=83) having experienced 2-4 events and 37.1% (n=49) with 5-10 events. The most common genotype in SCD, homozygous hemoglobin S (HbSS), was identified in most SUSTAIN patients (n=94; 71.2%), and patients with this genotype were evenly distributed between study arms.

The analysis found that treatment with crizanlizumab may prevent VOCs, both in patients who had 2-4 and 5-10 disease-related pain events in the year prior to the study, as well as those with HbSS.

Of the subgroups evaluated, a considerable number of patients across multiple subgroups treated with crizanlizumab did not experience a VOC compared with those treated with placebo, including:

• Those with 2-4 events in the year prior to participating in the study (17 out of 42 patients or 40.5% vs 10 out of 41 patients, or 24.4%)
• Those with 5-10 events in the year prior to participating in the study (7 out of 25 patients or 28.0% vs 1 out of 24 patients, or 4.2%)
• Those with the HbSS genotype (15 out of 47 patients or 31.9% vs 8 out of 47 patients, or 17.0%)
• Those also with concomitant use of hydroxyurea (14 out of 42 patients 33.3% vs 7 out of 40 patients, or 17.5%)

No new safety concerns emerged in the post hoc analysis as adverse events attributed to treatment were similar between the crizanlizumab and placebo arms across all subgroups.

“The insights gained from this analysis and others from the SUSTAIN study, strengthen our belief that crizanlizumab may become an important new therapeutic option for sickle cell patients who continue to need step changes in medical innovation,” said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. “This is another example of what we mean when we say we are reimagining medicine.”

https://www.streetinsider.com/Corporate+News/Novartis+%28NVS%29+says+analysis+shows+crizanlizumab+increased+number+of+patients+free+of+sickle+cell+pain+crises+vs+placebo+during+SUSTAIN+study/14689283.html

Trevena hit on FDA concerns ahead of key panel meeting

• Shares in Pennsylvania biotech Trevena slumped by more than 60% in value Tuesday morning, after documents released by the Food and Drug Administration raised a number of concerns about the company’s lead drug candidate.
• The drug, called oliceridine, is an intravenous opioid designed to treat moderate to severe acute pain. An FDA advisory panel is set to meet Thursday to review clinical results Trevena submitted to the agency in support of an application for approval.
• Trevena has pitched oliceridine as safer than currently available intravenous opioids, pointing to the drug’s mechanism of action as a key differentiating factor. Briefing documents from the FDA, however, reveal the agency had not agreed to Trevena’s plans to measure oliceridine’s impact on respiratory safety burden.

Investors typically pore over FDA briefing documents, which are published by the agency two days before advisory committee meetings. Staffed by experts, the panels make recommendations to the FDA for or against approval of certain experimental drugs.

Sometimes these documents offer few new insights into the agency’s thinking on a particular drug. In this case, it was clear FDA staff had several concerns about Trevena’s trial design and results.

For its New Drug Application for oliceridine, Trevena submitted results from three Phase 3 studies — two randomized and one conducted open-label. In both of these trials, the two higher tested doses of oliceridine showed a statistically greater reduction in pain intensity than placebo. (Comparisons versus morphine on this measure were more mixed.)

But key to Trevena’s case is the company’s claim that oliceridine’s more selective mechanism of action makes it safer than conventional opioids, with less respiratory depression and nausea.

On this point, it turns out, the FDA never agreed to Trevena’s plans for measuring the superiority of oliceridine to morphine in terms of respiratory safety burden. Further, in both randomized studies, Trevena’s drug did not demonstrate a significant lowering in the expected cumulative duration of respiratory safety events versus morphine, FDA staff wrote.

The agency acknowledged that trends did support a decreased percentage of respiratory events with oliceridine versus morphine but only on “some parameters.”

Respiratory safety burden wasn’t the only thing the FDA saw differently than Trevena, either. The documents disclosed the agency had a number of disagreements with the biotech in an April 2016 meeting and a November 2016 teleconference.

An announcement made by Trevena following the April sit-down gave investors no hints of the differences in view.

Overall, FDA staff were clear that oliceridine offered significant benefits in pain reduction over placebo. But, compared to morphine, the picture painted in the documents is less positive.

“The oliceridine 0.5 mg dose regimen looks to be slightly less efficacious than morphine, but with similar rates of dizziness, hypoxia, nausea, and vomiting,” FDA staff wrote. “The oliceridine 0.1 and 0.35 mg dose regimens appear to be even less effective than morphine, with correspondingly lower rates of selected adverse events.”

What the six voting members of the anesthetic and analgesic drug products advisory committee make of oliceridine in Thursday’s meeting will be a key test for the drug. Similarly mixed or negative reviews could spell trouble for Trevena.

https://www.biopharmadive.com/news/trevena-shares-sink-on-fda-concerns-ahead-of-key-panel-meeting/539229/