GlycoMimetics tumbles after announcing Phase 3 trial design

GlycoMimetics tumbles after announcing Phase 3 trial design for GMI-1271 in myeloid leukemia patients

 

GlycoMimetics tumbles, Stockwinners.com
GlycoMimetics announces new Phase 3 for GMI-1271

Earlier, GlycoMimetics announced its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC or in combination with FAI in individuals with relapsed/refractory acute myeloid leukemia.

The design is aligned with guidance received from the U.S. Food and Drug Administration.

The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018.

The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling, if GMI-1271 is approved by the FDA. In 2017, GMI-1271 received Breakthrough Therapy Designation.

“Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome,” said Rachel King, Chief Executive Officer of GlycoMimetics.

“Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population.

In addition, we believe that our trial design should streamline the path to data on overall survival, considered the ‘gold standard’ of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace.”

“Our development strategy now sets us up for multiple, value-creating clinical data readouts, the first of which is topline data from the ongoing Phase 3 trial of rivipansel in sickle cell disease in the second half of 2018,” Ms. King added.

“In early 2019, we anticipate topline data from our proof-of-concept trial of GMI-1271 in multiple myeloma, and now, by the end of 2020, we expect to have topline data from our pivotal trial of GMI-1271 in patients with relapsed/refractory AML.”

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GLYC closed at $22.82. In after hours trading it traded at $18.55.


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Netflix introduces PIN protection, Shares jump

Netflix introduces PIN protection, enhancements for ‘informed’ viewing

Disney loss having minimal impact on Netflix subscribers. See Stockwinners.com Market Radar to read more
Netflix introduces PIN protection, enhancements for ‘informed’ viewing

Mike Hastings, a director of enhanced content at Netflix (NFLX), said in a blog post: “At Netflix, we offer a wide variety of series and films catering to an equally broad variety of tastes and sensibilities.

With that in mind, we are improving some long-standing Netflix features that provide members with the information and tools they need to make wise decisions about what’s right for themselves and for their families.

We’re rolling out these improvements across the many devices used by Netflix members, and across our global markets, in the coming months. The first change involves introducing a PIN parental control for individual movies and series to give parents and guardians more specific control over what children can watch on the service.

We understand that every family is different and that parents have differing perspectives on what they feel is appropriate to watch at different ages.

While we already provide PIN protection for all content at a particular maturity level for Netflix accounts, PIN protection for a specific series or film provides families with an additional tool to make decisions they are comfortable with.

In addition, we will also begin displaying more prominently the maturity level rating for a series or film once a member hits play on a title. While these maturity ratings are available in other parts of the experience, we want to ensure members are fully aware of the maturity level as they begin watching.

We are also continuing to explore ways to make this information more descriptive and easier for our members to understand with just a quick glance. One of the great benefits of internet TV is that it allows for amazing variety and provides viewers with complete control over their experience.

At Netflix, we are proud to create and deliver to our members a large catalog of compelling stories crossing many genres from all over the world, while also giving them great control over how and when to enjoy them.

These latest steps are part of our continuous efforts to keep members better informed, and more in control, of what they and their families choose to watch and enjoy on Netflix.”

NFLX is up $11.0 to $312.89.


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GTx Phase 2 trial of enobosarm meets primary endpoint

GTx Phase 2 trial of enobosarm meets primary endpoint

 

GTx Phase 2 trial of enobosarm meets primary endpoint. Stockwinners.com
GTx Phase 2 trial of enobosarm meets primary endpoint

GTx  (GTXI) announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence, or SUI, including magnetic resonance imaging, or MRI results from patients’ pelvic floor muscle.

New data in a subset of women also suggests a positive treatment effect of enobosarm for urge incontinence, or UI, suggesting a possible treatment effect for women with mixed incontinence.

Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment.

Treatment with enobosarm also reduced mean UI episodes by approximately 68 percent in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI.

These results were outlined during a podium presentation which took place at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction.

The presentation included clinical data from all 18 patients completing 12 weeks of enobosarm treatment, which, as previously reported, demonstrated an 81% reduction in the number of mean stress leaks per day, the primary endpoint of the clinical trial, as well as additional data demonstrating duration of response following completion of treatment, including nine patients who have now reached seven months post-treatment.

MRI was used to quantitatively measure muscle in the pelvic floor of 17 women at 12 weeks compared to their baseline. The results showed a statistically significant increase in several important measurements and support the mechanism of action of enobosarm on the pelvic floor.

While all of the women in the trial had predominant SUI, some also experienced urge incontinence.

Eleven of the 18 women completing 12 weeks of treatment were determined to have both SUI and UI at baseline, and these 11 women with mixed incontinence demonstrated a mean reduction in their UI episodes of approximately 68%.

Consistent with previous findings, at the end of the 12-week treatment period, all of the 18 enobosarm-treated women showed a clinically meaningful reduction in stress urinary incontinence episodes per day.

The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period.

There were no serious adverse events reported and reported adverse events were minimal and included headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness and acne.

Mild transient elevations in liver enzymes that were within normal limits were observed, except for one patient with levels greater than 1.5 times the upper limit of normal which returned to normal following her 12-week treatment period. Reductions in total cholesterol, LDL-C, HDL-C and triglycerides were also observed.

GTXI closed at $16.81. It last traded at $19.00 in pre-market trading.


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Sorrento Therapeutics reports positive CAR-T cell therapy data

CAR-T cell therapy demonstrates therapeutic activity

CAR-T cell therapy demonstrates therapeutic activity. Stockwinners.com
CAR-T cell therapy demonstrates therapeutic activity

Sorrento Therapeutics (SRNE), cellular therapy focused subsidiary TNK Therapeutics and Surefire Medical announced initial results from the Hepatic ImmunoTherapy for Metastases-Surefire, or HITM-SURE, a Phase 1b single arm trial testing its autologous anti-CEA CAR-T cells administered regionally by hepatic artery infusion via pressure directed microvalve infusion technology in heavily pre-treated patients with refractory CEA-positive liver metastases.

This Phase 1b trial follows the HITM and HITM-SIR Phase 1 studies we believe demonstrated the safety and biological activity of the anti-CEA CAR-T administered with hepatic artery infusions alone or with selective internal radiotherapy.

The data of HITM-SURE were provided by Dr. Steven Katz, the Principal Investigator of the Study and Associate Professor of Surgery at The Roger Williams Medical Center.

The study is also open at Colorado University and funded in part by the Colorado Office for Economic Development and International Trade. In total, three patients have completed the ongoing HITM-SURE protocol, two with stage IV pancreatic cancer and one with colorectal cancer.

All patients presented with unresectable, chemotherapy refractory CEA+ liver metastases. Patients received three HAI of anti-CEA CAR-T cells along with low dose IL-2 infusion. CAR-T HAI were administered via a Surefire MVI technology. The primary objective of the study was to establish the safety of the CAR-T HAI with the pressure directed MVI device.

Secondary objectives included response assessed by modified RECIST, immune-related response criteria, and tumor marker kinetics. Reduction in post-treatment serum CEA was noted in all patients.

Two patients have progressive disease, with a pancreatic cancer patient alive at 7 months and a colorectal cancer patient alive at 4.8 months. A patient with stage IV pancreas adenocarcinoma has no evidence of liver metastases 11 months on PET scan following three CAR-T HAIs.

In the phase III MPACT study, treatment of stage IV pancreas adenocarcinoma patients with gemcitabine plus albumin-bound paclitaxel resulted in a median overall survival time of 8.7 months.

It will be of interest to determine if the results from upcoming phase 2 liver metastasis HITM studies will confirm the encouraging results from our small number of patients.

The initial findings from the currently enrolling HITM-SURE trial follows the results of two other trials. In one of the previous trials, a patient survived 51 months following 3 anti-CEA CAR-T HAIs and a patient from another trial is alive 25 months after treatment.

SRNE closed at $7.20.


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