AmpliPhi Updates Positive Clinical Results for Expanded Access Program

AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced updated topline clinical results for its ongoing single-patient expanded access program. 84% of patients achieved treatment success (physician’s assessment) at the end of therapy, defined as complete resolution or significant improvement of baseline signs and symptoms.

AmpliPhi has now provided its investigational bacteriophage therapeutics for a total of 21 patients, at 7 hospitals, with serious or life-threatening infections not responding to antibiotic therapy. These patients were treated with AB-SA01 or AB-PA01 under single-patient expanded access programs in the U.S. (Emergency INDs per the U.S. Food and Drug Administration) or Australia (Special Access Scheme per the Australian Therapeutic Goods Administration). The following analysis updates the data previously announced by the company on January 3, 2018:

• 15 patients with serious S. aureus infections were treated with AB-SA01 and 6 patients with serious P. aeruginosa infections were treated with AB-PA01.
• Infections in the treated patients included bacteremia, native and prosthetic valve endocarditis, recurrent pneumonia, ventilator-associated pneumonia, prosthetic joint infection, ventricular assist device infection, and others.
• Over 1,000 bacteriophage doses were administered as part of the expanded access program including:
  • 400+ doses of AB-SA01, including 300+ doses administered intravenously. Treatment was well-tolerated in all patients with no treatment related serious adverse events (SAEs).
  • 600+ doses of AB-PA01, including 400+ doses administered intravenously. Treatment was well-tolerated in five patients. One patient discontinued treatment due to Grade 1 and 2 adverse events, which resolved within 18 hours. There were no treatment-related SAEs.
• 84% (16 out of 19) of patients in the modified intent-to-treat population (mITT) achieved treatment success at the end of therapy. Treatment success, as determined by the treating physician, was defined as a complete resolution or significant improvement of baseline signs and symptoms. mITT population was defined as all patients who met the criteria for clinical diagnosis, whose bacterial isolate was susceptible to phage and who received at least one dose of phage.

“The encouraging results from AmpliPhi’s expanded access program support the view that phage therapeutics can be safely administered and provide anecdotal evidence of their efficacy, which we hope to soon demonstrate in randomized, controlled clinical trials,” said Dr. Jonathan Iredell, Senior Staff Infectious Diseases Physician at the Westmead Hospital in Sydney, Director of Centre for Infectious Diseases and Microbiology at the Westmead Institute of Medical Research and Professor of Medicine and Microbiology at the University of Sydney. “I look forward to helping bring this potentially important new modality to seriously ill patients, including those in whom usual treatment options are commonly inadequate.”

https://www.biospace.com/article/releases/ampliphi-biosciences-announces-updated-positive-clinical-results-for-its-expanded-access-program/

Arena Pharmaceuticals Has Preclinical Data at Pain World Congress

Arena Pharmaceuticals, Inc., Inc. (Nasdaq: ARNA) today announced that results from preclinical studies of its investigative drug candidate olorinab, a peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 (CB₂) in development for the treatment of visceral pain associated with Crohn’s disease, were presented at the International Association for the Study of Pain (IASP) World Congress in Boston, MA.

“We are pleased to present data supporting olorinab’s antinociceptive effects in visceral sensory pathways,” said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. “Through its full-agonism and selectivity, we believe olorinab may provide a novel therapeutic approach for sustained relief of visceral pain without psychotropic effects, potentially providing a new treatment option without the risk for dependence or abuse. We are currently evaluating olorinab in a Phase 2 clinical trial in IBD-associated abdominal pain and expect the availability of topline data by the end of the third quarter.”

Presentation Details
Poster Abstract Title: APD371, a Peripherally Restricted, Highly Selective, Full Agonist of the Cannabinoid Receptor 2 (CB2) Receptor, Reduces Colitis-Induced Visceral Hypersensitivity in Rats
Poster Number: PFR455
Presentation Date: Friday, September 14

https://www.biospace.com/article/releases/arena-pharmaceuticals-presents-preclinical-data-for-olorinab-at-international-association-for-the-study-of-pain-world-congress/

Catasys Expands OnTrak-A Solution to Iowa, Neb. with Leading US Health Plan

Source: Catasys, Inc. Multimedia Gallery URL

• National Plan Expands OnTrak-A into 10^th and 11^th States
• OnTrak-A Offered to Both Commercial and Medicare Advantage Plan Members
• With This Launch, OnTrak Is Now Available in 22 States

Catasys, Inc. (CATS) (“Catasys” or the “Company”), a leading AI and technology-enabled healthcare company, today announced that it has expanded its OnTrak-A solution into Iowa and Nebraska with one of the nation’s leading health plans, which is the second largest plan in both states.

Eligible commercial and Medicare Advantage plan members in these states are now able to participate in OnTrak-A, an integrated 52-week program that identifies, engages and treats members with unaddressed behavioral health conditions that impact co-morbid medical conditions, such as diabetes, hypertension, coronary artery disease, COPD, and congestive heart failure, resulting in high medical costs. With this expansion, the OnTrak program is now available in 22 states to members of major health plans.

“This expansion demonstrates this national plan’s continued confidence in our ability to improve the health of their members and deliver savings to the national plan as they continue to roll us out into additional states,” said Rick Anderson, President and Chief Operating Officer of Catasys. “We look forward to assisting members in all 11 states where we are contracted with this partner to achieve better health and better lives.”

Catasys, Inc. harnesses proprietary big data predictive analytics, artificial intelligence and telehealth, combined with human intervention, to deliver improved member health and cost savings to health plans through integrated technology enabled treatment solutions. It is our mission to provide access to affordable and effective care, thereby improving health and reducing cost of care for people who suffer from the medical consequences of behavioral health conditions; helping these people and their families achieve and maintain better lives.

Catasys’ OnTrak solution–contracted with a growing number of national and regional health plans–is designed to treat members with behavioral conditions that cause or exacerbate co-existing medical conditions such as diabetes, hypertension, coronary artery disease, COPD, and congestive heart failure, which result in high medical costs.

Catasys has a unique ability to engage these members, who do not otherwise seek behavioral healthcare, leveraging proprietary enrollment capabilities built on deep insights into the drivers of care avoidance matched with data driven engagement technologies.

OnTrak integrates evidence-based medical and psychosocial interventions along with care coaching in a 52-week outpatient solution. The program is currently improving member health and, at the same time, is demonstrating reduced inpatient and emergency room utilization, driving a more than 50 percent reduction in total health insurers’ costs for enrolled members. OnTrak is available to members of several leading health plans in California, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Nebraska, New Jersey, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia and Wisconsin.

https://finance.yahoo.com/news/catasys-expands-ontrak-solution-iowa-120000924.html

Cannabis stocks rise amid interest by Coca-Cola, opportunities for Shopify

Shares of cannabis stocks are in focus following a report that Coca-Cola (KO) is in talks with Aurora Cannabis (ACBFF) as it eyes the cannabis industry and an analyst note from Keybanc which said Shopify (SHOP) has cannabis potential. COCA-COLA EYES CANNABIS: Coca-Cola is monitoring the nascent cannabis drinks industry and is in talks with Canadian marijuana producer Aurora Cannabis to develop the drinks, Bloomberg reported Monday. “We are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world,” Coca-Cola spokesman Kent Landers said. “The space is evolving quickly. No decisions have been made at this time” Landers added. The move comes as beverage makers are looking towards cannabis as soda consumption and traditional business slows. Constellation Brands (STZ, STZ.B) previously announced it will spend $3.8B to increase its stake in Canadian marijuana producer Canopy Growth (CGC) and Molson Coors Brewing (TAP) is starting a joint venture with Quebec’s Hydropothecary to develop cannabis drinks. In addition, Diageo (DEO) has been holding talks with at least three Canadian cannabis producers regarding a potential deal and Heineken’s (HEINY) Lagunitas label has launched a brand focused on non-alcoholic drinks infused with THC. SHOPIFY MAY BENEFIT FROM CANNABIS SALES: KeyBanc analyst Monika Garb told investors in a research note on Monday that she is a buyer of Shopify, as the company has “ample” growth opportunities ahead. She sees potential upside to her above-consensus estimates and expects that recreational sales of cannabis in Canada could be a general merchandise volume and revenue driver further benefiting Shopify’s business momentum. The analyst said the company has been selected by several Canadian provinces to run their e-commerce sites and in-store point of sale solutions and has also signed deals with private cannabis producers and distributors, including Canopy Growth and Aurora. Additionally, Garb says Shopify is the best positioned to benefit from growth in emerging brands, citing brands like Rebecca Minkoff and Kyle Cosmetics that already use Shopify. Garb maintained an Overweight rating and $182 price target on shares. CANNABIS STOCKS: Publicly-traded companies in the space include Cronos Group (CRON), Canopy Growth, Tilray (TLRY), Cannabis Science (CBIS), Innovative Industrial Properties (IIPR) and Aurora Cannabis. PRICE ACTION: Aurora Cannabis gained over 16% in morning trading, while Tilray gained 7.3%.

https://thefly.com/landingPageNews.php?id=2791393

Progenics says AZEDRA added to NCCN guidelines

Progenics announced that AZEDRA has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors v 3.2018. NCCN Guidelines are widely recognized and used as the standard for clinical policy in oncology by clinicians and payors.

https://thefly.com/landingPageNews.php?id=2791025

Aslan Pharmaceuticals updates timeline for trial of varlitinib plus capecitabine

ASLAN Pharmaceuticals announced an update to its planned timelines for the ongoing single-arm clinical trial in China testing varlitinib plus capecitabine in patients with advanced or metastatic biliary tract cancer. The open-label study planned to enrol 68 patients with BTC who had progressed on at least one line of prior chemotherapy. Based on a review of patients recruited to-date and discussions with key investigators, it was agreed that a protocol amendment should be submitted to local authorities to modify enrolment criteria and to ensure the study will provide an accurate evaluation of varlitinib’s efficacy. Review and implementation of the voluntary amendment is expected to take approximately 4 months. In the interim, ASLAN will continue to recruit patients into the study and provide a further update on study timelines in early 2019. ASLAN’s global pivotal study in second line BTC, TREETOPP, remains on track to complete patient enrolment in early 2019. TREETOPP is a randomised, double-blind, placebo-controlled clinical trial in second line BTC comparing varlitinib and capecitabine to placebo and capecitabine. If positive, data from the TREETOPP study will be used in regulatory approval submissions for varlitinib globally. Patients enrolled into the second line study in China appear to have performed significantly worse, prior to recruitment, in the first line setting than observed in published global studies. In the first 27 patients enrolled, the first line response rate was approximately 7% and progression free survival (PFS) was 2.7 months. In comparison, the ABC-021 study that compared cisplatin plus gemcitabine to gemcitabine alone, the current standard of care for first line treatment of patients with advanced BTC, showed a first line response rate of 26% and PFS of 8 months for patients on cisplatin and gemcitabine. In the 14 patients that received a 6-week scan in the study, 1 partial response and 6 patients with stable disease were reported based on site assessment. For the same 14 patients in the first line setting, there were 2 partial responses and 4 patients with stable disease.

https://thefly.com/landingPageNews.php?id=2791079

Mersana Therapeutics announces FDA lifts partial clinical hold on XMT-1522

Mersana Therapeutics announced that the FDA has lifted the partial clinical hold on the Phase 1 study of XMT-1522. Mersana and the FDA reached alignment on changes to the protocol, including increased monitoring as well as the exclusion of patients with advanced hepatic impairment. Although XMT-1536, Mersana’s Dolaflexin ADC targeting NaPi2b, was not subject to a clinical hold, Mersana has decided to implement similar modifications to the XMT-1536 protocol. In addition, alternative dosing regimens will be evaluated for both clinical trials.The XMT-1522 trial will begin with a once-every-four-week dose regimen. This dosing regimen has already been implemented in the XMT-1536 trial at previously explored dose levels in order to enable a comparison of relevant doses and their impact on the safety, efficacy and PK profile of the drug candidate. The company may evaluate additional regimens as well. Data on XMT-1536 is expected in the first half of 2019.

https://thefly.com/landingPageNews.php?id=2791097