Phase Archives - Mediarabe

CytRx Highlights Use of Licensed Drug Aldoxorubicin in ImmunityBio’s Expanded Phase 2 Study of Pancreatic Cancer Treatment

October 13, 2020

Third-Line Cohort Added to Phase 2 Pancreatic Cancer Trial for Combination Immunotherapy That Includes Aldoxorubicin, ImmunityBio’s N-803 and NantKwest’s PD-L1 t-haNK

Three Trial Sites in California and South Dakota Will Initially Enroll 298 Patients Across the Cohorts, With 40 Patients Already Enrolled or Being Evaluated

CytRx Corporation (OTCQB:CYTR) (“CytRx” or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that ImmunityBio, Inc. and NantKwest, Inc. (collectively, the “Companies”) have announced the addition of a third cohort to their ongoing Phase 2 study of a novel combination immunotherapy – which includes CytRx’s licensed drug aldoxorubicin – for locally advanced or metastatic pancreatic cancer (QUILT-88). According to the Companies, the third cohort will enable pancreatic cancer patients who have failed all approved standards of care to participate in the study.

As previously noted in CytRx’s October 7, 2020 press release regarding

Gossamer Bio Announces Topline Results for Phase 2 Trials of Oral GB001 in Asthma and Chronic Rhinosinusitis

October 13, 2020

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– Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups –

– Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group –

– TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints –

– Gossamer to hold webcast to discuss trial results at 8:00 am EDT –

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.

“While we did not achieve statistical significance

Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis

October 12, 2020

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— Filgotinib 200mg Achieved Endoscopic, Histologic and Six-Month Corticosteroid-Free Remission at Week 58 with a Consistent Safety Profile —

— Study Enrolled Biologic-Naïve and Biologic-Experienced Patients, a High Proportion of Whom Were Highly Refractory —

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis (UC). The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission. The full results were presented today at the 2020 United European Gastroenterology Week (UEGW) Virtual Meeting (Abstracts #LB19 and #LB20).

This press release features multimedia. View the

South Korea’s Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

October 12, 2020

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By Sangmi Cha

SEOUL (Reuters) – South Korean drugmaker Celltrion Inc <068270.KS> said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion’s senior executive vice president, told Reuters.

Lamont Considers Phase 3 Opt-Out For Coronavirus Outbreak Towns

October 9, 2020

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CONNECTICUT — Gov. Ned Lamont is now considering giving towns with a high volume of coronavirus cases discretion to stay at the second reopening phase.

“I think we are thinking about this on a town-by-town basis and perhaps giving those towns some discretion not to move to phase three, to stay at phase two,” Lamont said at a news conference.

Connecticut’s third reopening phase started Thursday. It increases indoor restaurant and personal service capacity from 50 to 75 percent. It also increases capacity at private social commercial gatherings like weddings as well as religious services, graduation ceremonies, outdoor entertainment and indoor performing arts.

The discretion to stay or roll back to phase two would be given if a town reached 15 coronavirus cases per 100,000 residents over a two-week rolling average. The state average is closer to seven per 100,000.

The eastern part of the state and particularly New London

Pfizer and Sangamo Dose First Participant in Phase 3 Study Evaluating Hemophilia A Gene Therapy Treatment

October 7, 2020

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Pfizer Inc. (NYSE: PFE) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201007005049/en/

AFFINE is a global Phase 3, open-label, multicenter, single arm study that will evaluate the efficacy and safety of giroctocogene fitelparvovec in patients with moderately severe to severe hemophilia A. The primary endpoint is impact on annual bleed rate (ABR) through 12 months following treatment with giroctocogene fitelparvovec, compared to ABR on Factor VIII (FVIII) replacement therapy collected in the Phase 3 lead-in study period. Participants will be analyzed throughout the 5-year study period following the single infusion to further assess the durability and efficacy.

“The initiation of the pivotal Phase 3 dosing study of giroctocogene fitelparvovec is

New Data from Corvus Phase 1 Study of CPI-006 Continues to Support its Potential as a Treatment for COVID-19

October 5, 2020

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Figure

Anti-SARS-CoV-2 antibody response (IgG and IgM) to spike protein and RBD of SARS-CoV-2. Patients receive 0.3 or 1.0 mg/kg single dose of CPI-006 and antibody titers measured at pre-treatment and at Days 28 and 56. Data are shown as box and whisker plot with geometric mean and interquartile ranges.

Enrollment in first three cohorts complete; final cohort now enrolling with plans to initiate a pivotal study before year-end

Data continues to support the novel immunotherapy based on B cell activation with CPI-006, including the inducement of sustained high titers of SARS-CoV-2 specific antibodies and increased levels of memory B c

Poxel Announces Positive Results From Phase 2a NASH Trial With PXL770, an Oral First-in-Class Direct AMPK Activator

October 1, 2020

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The Phase 2a trial for the treatment of NASH met its primary efficacy endpoint; PXL770-treated patients achieved statistically significant improvement in the relative decrease in liver fat mass measured by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) at 12-weeks with a greater response in patients with type 2 diabetes¹
Key secondary measures in PXL770-treated patients included statistically significant observed improvements in liver enzymes – alanine transaminase (ALT) and hemoglobin A1c (HbA1c)
PXL770 was observed to be safe and well tolerated; profile supports further evaluation for combination use
First human clinical assessment of a direct AMPK activator; results support potential for development in NASH including key high-risk subgroups (patients with type 2 diabetes) and utility of AMPK activation in other chronic and rare metabolic diseases
Conference call in English scheduled today for 12:00 pm EDT (New York time) / 6 pm CEST (Paris time)

POXEL SA (Euronext: POXEL –

Soil Cleanup At Bethpage Community Park Undergoing Next Phase

September 30, 2020

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BETHPAGE, NY — Northrop Grumman recently launched the next phase of soil cleanup at Bethpage Community Park.

On Aug. 26, the global aerospace and defense technology company turned on heating equipment to warm the soil beneath Bethpage Community Park — marking a major milestone toward returning the ball field to community use, the company announced in a news release.

The technology will warm the soil over a six-month period to vaporize the chemicals found deep in the soil. The company’s processing equipment will vacuum the vapor, scrub the chemicals from the vapor, and release the treated air to the atmosphere.

“This process is a proven, safe and widely-used method across the State of New York that does not present any risk to the community,” the company wrote.

Northrop Grumman’s work is being conducted with approval from the New York State Department of Environmental Conservation (NYSDEC) and the New York State

Madison Schools Nearing Phase 2 Of Reopening

September 27, 2020

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MADISON, NJ—Madison School District Superintendent Mark Schwarz provided an update on the status of the district’s reopening plan on Monday, one day after the first coronavirus case was reported in the schools.

“While all students benefit from being in school everyday,” said Schwarz, “our younger students carry the least risk and the greatest reward from in-person learning. While we finalize our procedural, scheduling and safety preparations for Phase 2, please know that we will be giving priority in this shift to our elementary students. Nevertheless, we are simultaneously planning for Phase 2 at MJS and MHS.”

The district announced its first potential coronavirus case on Sunday, when the district said a member of the Central Avenue School community has tested positive for the virus.

“While this case has not yet been confirmed by the NJDOH,” Schwarz said, “we are proceeding with the assumption that this is a positive case. Based