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.
Monday, September 17, 2018
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.
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.
Data on IL36R inhibitor positive for AnaptysBio, says Cantor Fitzgerald
Cantor Fitzgerald analyst Eliana Merle views the first clinical data of an IL36R inhibitor in patients presented at EADV Congress as a positive read-through to AnaptysBio’s IL36R program. Anaptys’s second wholly owned clinical stage asset, ANB019, is an IL36R inhibitor in development for rare forms of psoriasis, Merle tells investors in a research note. She points out that data over the weekend from a competitor program, BI 655130, showed that IL36R inhibition can lead to clinically meaningful improvement in generalized pustular psoriasis. The analyst thinks this de-risks the IL36R mechanism ahead of initial patient data from ANB019 in GPP in early 2019. Merle keeps an Overweight rating on AnaptysBio with a $124 price target
KemPharm has topline results from abuse-potential trial of med
KemPharm announced topline results from its intranasal, or IN, human abuse potential, or HAP, clinical trial of serdexmethylphenidate, the major active pharmaceutical ingredient in KP415, KemPharm’s investigational product candidate for the treatment of ADHD. In the IN HAP trial, SDX produced significantly lower scores on the primary endpoint, maximal drug liking, and other abuse-related endpoints, compared to intranasal d-methylphenidate hydrochloride, indicating that SDX is not efficiently converted to active d-methylphenidate when snorted. KemPharm will present the data from all three HAP trials, as well as tampering study results, to the FDA as part of its human abuse potential assessment for SDX in the KP415 new drug application, or NDA. During the review process, the FDA will recommend a controlled substance schedule for SDX to the Drug Enforcement Agency, or DEA. If KP415 is approved, the DEA must subsequently confirm the schedule for SDX, and KemPharm believes that the entirety of the data may support a lower schedule compared to other currently available methylphenidate-based ADHD products. Furthermore, since the FDA has required KemPharm to conduct all three HAP trials, KemPharm anticipates that data from these trials may likely be included in the label.
NuVasive price target raised to $80 from $70 at Canaccord
Canaccord analyst Kyle Rose raised his price target on NuVasive to $80 from $70 following meetings with management. The analyst believes the shares offer a compelling risk/reward setup in medtech citing its conservative guidance, robust new product flow, stable U.S. spine market share, and improving investor sentiment. Rose reiterated his Buy rating on NuVasive shares.
Tenet hospitals in South Carolina fully operational after Hurricane Florence
Tenet Healthcare announced that its four hospitals in South Carolina are fully operational following Hurricane Florence and meeting the healthcare needs of the communities they serve. Coastal Carolina Hospital, East Cooper Medical Center and Hilton Head Hospital, which are all located in areas impacted by the storm, had no material damage. These hospitals resumed normal operations over the weekend, and it is noteworthy that they remained open during the storm. East Cooper Medical Center in Mt. Pleasant, S.C., received an exception to the mandatory evacuation order issued by the Governor of South Carolina and remained open with reduced census and an operational emergency room. Piedmont Medical Center was not directly impacted by the storm and remained fully operational. USPI has eight surgery centers in areas impacted by the storm. Those facilities are in the process of rescheduling cancelled cases, with plans in place to be operational as of today.
https://thefly.com/landingPageNews.php?id=2791207
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