Novo Nordisk announced the headline results from Pioneer 2, the second Phase 3a trial with oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet. The 52-week, open label trial investigated the efficacy and safety of 14 mg oral semaglutide compared with 25 mg empagliflozin in 816 people with type 2 diabetes, inadequately controlled on metformin. The confirmatory endpoints were defined after 26 weeks of treatment. The trial achieved its primary objective according to the primary statistical approach by demonstrating a statistically significant and superior improvement in HbA1cwith oral semaglutide compared to empagliflozin at 26 weeks. Difference in weight loss at 26 weeks between oral semaglutide and empagliflozin was not statistically significant when applying the primary statistical approach. When applying the secondary statistical approach, people treated with 14 mg oral semaglutide achieved a statistically significant improvement in HbA1cof 1.4% at 26 weeks and 1.3% at 52 weeks, compared to an improvement in HbA1cof 0.9% and 0.8% with 25 mg empagliflozin at 26 and 52 weeks, respectively. The 14 mg dose of oral semaglutide demonstrated weight loss of 4.2 kg at 26 weeks and 4.7 kg at 52 weeks versus 3.8 kg with 25 mg empagliflozin at both 26 weeks and 52 weeks. The increased weight loss with oral semaglutide was statistically significant compared to empagliflozin at the 52-week time point. In the trial, oral semaglutide was well-tolerated and with a profile consistent with GLP-1-based therapy, Novo said. The most common adverse event for oral semaglutide was mild to moderate nausea, which diminished over time, it added. In Pioneer 2, 20% of people treated with oral semaglutide experienced nausea during the trial. The proportion of subjects who discontinued treatment due to adverse events was 11% for people treated with 14 mg oral semaglutide compared to 4% for people treated with 25 mg empagliflozin
Tuesday, May 29, 2018
Northwest Biotherapeutics has positive Phase 3 data from brain cancer trial
Northwest Biotherapeutics (OTCQB: NWBO) — (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today the publication of interim blinded survival data from its Phase 3 clinical trial of DCVax®-L for newly diagnosed Glioblastoma brain cancer. The data were collected by the independent contract research organization managing the trial, tabulated by an independent statistical firm and published with 69 co-authors in the peer reviewed Journal of Translational Medicine (JTM).
The trial is ongoing while the data continue to mature, and the Company, the investigators and patients all remain blinded. The interim data set forth in the JTM publication are blinded aggregate data which include patients from both arms of the trial combined: the arm with 2/3 of the patients, who received standard of care plus DCVax-L, and the arm with 1/3 of the patients, who received standard of care plus a placebo. When the patients experienced tumor recurrence, all patients from both arms were allowed to cross over and start receiving DCVax-L, but without being unblinded as to what they had received before tumor recurrence. The patient population enrolled in the trial is similar to that in other recent trials, and more than 75% of the patients were over 50 years old (a factor associated with less favorable outcomes).
Due to the crossover design, nearly 90% of the total 331 patients in the trial have received DCVax-L treatment. For the total 331 patients (both arms of the trial combined) the median survival as of this analysis was 23.1 months from surgery. With the standard of care (SOC) today (surgery, radiation and chemotherapy), median survival for newly diagnosed Glioblastoma is 15-17 months.
For patients with methylated MGMT gene status (131 patients), median survival was 34.7 months from surgery. With standard of care today, median survival for these patients has been reported in the literature as 21.7 months. For patients with unmethylated MGMT gene status (162 patients), the median survival was 19.8 months from surgery. With standard of care today, the median survival for these patients has been reported in the literature as 12.7 months. (MGMT data was not available for 38 patients.)
The top 100 patients (30%) of the total 331 patients in the trial showed particularly extended survival, with median survival of 40.5 months from surgery. This extended survival was not fully explained by known prognostic factors such as age younger than 50 years, methylated MGMT gene status and complete resection (surgical removal) of all of the tumor. Only 8% of these 100 patients had the favorable status on all 3 of these prognostic factors.
With immune therapies, the “long tail” of the survival curve is of particular importance and focus. In this DCVax-L trial, patients who survive past certain time points, have continued onwards to substantially extended survival. The patients are continuing to move through time points based upon when they had their surgery, and only some of the patients had reached certain time points in this trial as of this analysis. For example, 223 patients were ≥30 months past their surgery date as of this analysis; 67 of these (30.0%) have lived ≥30 months and these patients have Kaplan-Meier (KM)-derived median survival estimate of 46.5 months. Also as of this analysis, 182 patients were ≥36 months past their surgery date; 44 of these (24.2%) have lived ≥36 months and these patients have KM-derived median survival estimate of 88.2 months.
The administration of DCVax-L involves only an intra-dermal injection in the arm, similar to a flu shot, 3 times in the first month of treatment, 3 additional times over the rest of the first year (at months 2, 4 and 8), and twice a year thereafter. It thereby involves only a minimal burden on the patient.
DCVax-L has shown an excellent safety profile in the trial. The DCVax-L product has been administered well over 2,000 times, and only 7 of the 331 patients (2.1%) have experienced a serious adverse event that was deemed at least possibly related to the treatment. The rate of total adverse events (including non-serious events) was comparable to the rate of adverse events with standard of care alone.
“These are just interim data, and the data may get either better or worse as they continue to mature” commented Linda Powers, the Company’s CEO. “However, the survival times we are seeing are encouraging, especially in light of how little progress has been made in decades in treatments for Glioblastoma.”
“We have noted a growing recognition in the immuno-oncology field of the exceptional heterogeneity and complexity of Glioblastoma, and the need for treatments to target multiple antigens on these tumors” Ms. Powers continued. “DCVax-L is designed to use Nature’s system to mobilize an anti-tumor immune response, targeting the full set of antigens on a patient’s tumor and doing so in a fully personalized way. We believe this approach is key to the clinical results we are seeing.”
“The safety profile of DCVax-L is also quite encouraging, with almost no serious adverse events related to the treatment, no necessity for additional drugs to manage side effects and no hospital in-patient stays as are often required with certain other kinds of immune cell therapies” Ms. Powers noted. “This safety profile is quite important to patients, and we believe it can also facilitate combining DCVax-L with a variety of other types of treatments.”
The reported data are from the most recent prior full data collection in 2017. The Company is undertaking another full data collection, which is a multi-month process and will be continuing over the coming months.
The publication can be found on the JTM website at https://doi.org/10.1186/s12967-018-1507-6 .
Educational Development conference call May 30
EDUCATIONAL DEVELOPMENT CORPORATION (NASDAQ:EDUC) Files An 8-K Results of Operations and Financial Condition
Item 2.02. Results of Operations and Financial Condition.
Item 2.02. Results of Operations and Financial Condition.
Item 7.01. Regulation FD Disclosure.
On May 29, 2018, Educational Development Corporation, announced via press release, fiscal 2018 results. Educational Development Corporation’s earnings call will be held on May 30th, 2018 at 2:00 cst. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 8.01. Other Events.
On May 25th, 2018 Educational Development Corporation declares, via press release, a quarterly dividend. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
EDUCATIONAL DEVELOPMENT CORP Exhibit
EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1Educational Development Corporation Announces Record Fiscal 2018 TULSA,…
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EDUCATIONAL DEVELOPMENT CORP Exhibit
EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFilingEXHIBIT 99.1Educational Development Corporation Announces Record Fiscal 2018 TULSA,…
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hereShareholders demand Japan’s Takeda assuage fears over Shire deal
Japanese drugmaker Takeda Pharmaceutical Co Ltd faces demands from disgruntled shareholders to put to a vote its $62-billion (46.8 billion pounds) acquisition of London-listed Shire and do more to assuage concerns over the record-breaking deal.
The deal “carries overly high risks to the company” given its size, 12 shareholders said in a proposal to be voted on at next month’s annual shareholders’ meeting, adding that new shares to be issued to fund the deal threaten “a danger of causing a great disadvantage to existing shareholders”.
The Shire deal and any future deals worth more than 1 trillion yen (£7 billion) should be put to a shareholder vote, says the proposal – which will need two thirds of votes at the meeting to pass, according to a Takeda spokesman.
Takeda’s board of directors opposes the proposal, according to the company’s notice of convocation that contained the proposal, saying the need for prior approval for such deals would damage competitiveness and the company’s ability to make decisions.
However, the drugmaker already plans to put the Shire deal to a vote at an extraordinary general meeting, with two-thirds support needed. It will also need three-quarters backing from Shire investors.
Many investors have been lukewarm on the deal, fearing it will overstretch Takeda’s finances, with shares at the drugmaker trading down more than 25 percent since it first said it was considering bidding for Shire.
The proposal was received on April 27, a Takeda spokesman said, before the terms of the Shire deal were announced on May 8.
Bayer wins approval to buy U.S. seed and agrichemical giant Monsanto
Bayer won U.S. antitrust approval for its planned takeover of Monsanto on Tuesday on condition that it sell about $9 billion (6.8 billion pounds) in assets, the Justice Department said, clearing a major hurdle for the $62.5 billion deal.
ResMed to acquire HEALTHCAREfirst software provider
ResMed announced it has entered into a definitive agreement to acquire privately held HEALTHCAREfirst, a provider of software solutions and services for home health and hospice agencies. HEALTHCAREfirst offers electronic health record software, billing and coding services, and advanced analytics that enable home health and hospice agencies to optimize their clinical, financial and administrative processes. HEALTHCAREfirst will complement ResMed’s existing software solutions offered by Brightree, a wholly owned subsidiary ranked as one of the top 100 healthcare IT companies in the United States. The transaction’s financial terms were not disclosed, but the transaction will not be material to ResMed’s consolidated financial results.
Aiming at Sanofi, Shire meds, Atlas gene therapy startup Avrobio files $86M IPO
Avrobio has filed for an $86.25 million IPO. The offering would give the Atlas Venture-backed startup the means to run clinical trials of gene therapies designed to supplant enzyme replacement therapies from Sanofi, Shire and Pfizer.
Cambridge, Massachusetts-based Avrobio’s approach entails taking hematopoietic stem cells from patients and using lentiviral vectors to insert a copy of the gene that is defective in the target disease. Patients then undergo a conditioning regimen—which Avrobio thinks is milder than that used by other ex vivo lentiviral-based gene therapies—before receiving a shot of the gene therapy to induce lasting production of the enzyme behind their condition.
Avrobio is using the approach to treat lysosomal storage diseases, a group of indications in which the efficacy of replacing missing enzymes is proven. Today, patients with Fabry disease—Avrobio’s top target—receive frequent, multi-hour infusions of enzyme replacement therapies made by Sanofi and Shire. Avrobio wants to replace these infusions with a one-time gene therapy that equips the body to make the missing enzyme.
The startup is still some way from showing it can deliver on this potential and unseat the incumbents. Two patients have received AVR-RD-01, the Fabry disease gene therapy. Levels of the enzyme alpha-galactosidase A began to rise days after receiving the therapy and remain elevated as much as 12 months later. The AGA level of the patient with 12 months of follow-up has fallen over the past six months but is still above that seen in men with classic Fabry disease.
With the trial yet to see any serious adverse events linked to the treatment, Avrobio is preparing to move the lead candidate into a larger phase 2 trial. The multinational study will enroll eight to 12 treatment-naïve patients, give them a single dose of AVR-RD-01 and track them for 48 weeks. Avrobio will transition to a new lentiviral vector designed to boost efficacy during the phase 2 trial.
Avrobio expects to get the phase 2 trial underway around the middle of this year. Beyond that, the biotech is eyeing phase 1/2 trials of gene therapies against Gaucher disease and cystinosis. Dosing of the first patients in those trials is penciled in for next year.
Private investments from Atlas, Clarius Life Sciences, SV Life Sciences and others left Avrobio with $58 million in cash and equivalents as of the end of March. The addition of IPO monies would set Avrobio up to initiate the aforementioned trials while also moving a Pompe disease prospect through preclinical development.
In turning to public investors to fund the work, Avrobio has joined a clutch of gene therapy startups seeking to ride the wave of positive sentiment sparked by Novartis’ $8.7 billion takeover of Avexis and Spark Therapeutics’ landmark approval. This year, Homology Medicine, Rocket Pharmaceuticals and Solid Biosciences have bolstered the ranks of public gene therapy biotechs. MeiraGTx and Avrobio have filed the paperwork to join them.
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