Oncolytics Biotech (ONCY) Reports KRAS-Mutated Data from Phase 2 Pancreatic Cancer Study Sep 16, 2014 05:22PM

Oncolytics Biotech Inc. (NASDAQ: ONCY) today announced overall and KRAS-mutated patient data from a two-arm randomized phase 2 study of carboplatin, paclitaxel plus REOLYSIN (test arm) versus carboplatin and paclitaxel alone (control arm) in the first line treatment of patients with recurrent or metastatic pancreatic cancer (NCI-8601). The trial is sponsored by the U.S. National Cancer Institute (NCI) through a clinical trials agreement between the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis and Oncolytics. Oncolytics provided clinical supplies of REOLYSIN for the study and paid for the immune and genetic testing of the patients.

Summary Findings The overall objectives of the study were to determine the progression free survival of the overall patient population and the patient population according to KRAS mutation status.

Overall patient population The study enrolled 73 patients; 37 were in the control arm, 36 were in the test arm. The median progression free survival for the control arm was 5.16 months (95% confidence interval (CI) = 2.267 to 6.176) versus 5.26 months for the test arm (95% CI = 3.187 to 6.307) (see Figure 1).

Figure 1 - Kaplan-Meier plot of the Progression Free Survival (PFS) of the control arm versus the test arm of the overall patient population. See Figure 1 link at bottom of this release.

KRAS mutated patient population As part of the study design, patients were screened for KRAS status at codon 12. Of the 60 patients where KRAS status could be determined (mutant vs wild type), 44 (73%) had mutations in the KRAS gene (n = 23 in the control arm, n = 21 in the test arm). Median progression free survival in the test arm was 5.72 months (95% CI = 3.187 to 6.767) versus 4.11 months in the control arm (95% CI = 1.938 to 6.176) (see Figure 2). This translates into a 1.61 month (39%) improvement in median progression free survival in the test arm versus the control arm. Three patients on the test arm and one on the control arm had not progressed as of the time of analysis.

Figure 2 - Kaplan-Meier plot of the Progression Free Survival (PFS) of the control arm versus the test arm of the KRAS mutated patient population. See Figure 2 link at bottom of this release.

Crossover patient population Patients on the control arm who progressed on carboplatin and paclitaxel had the option of adding REOLYSIN to their regimen. At the time of the analysis, 16 patients crossed over to the test arm regime. The best responses after crossover were one partial response (PR), six stable disease (SD), seven progressive disease (PD), and two not evaluable, giving a disease control rate (complete response (CR) + PR + SD) of 50% in the carboplatin and paclitaxel failed group.

"This is the first randomized clinical evidence that screening patients for their KRAS status could influence their clinical outcomes when treated with a drug regime that includes REOLYSIN," said Dr. Alan Tuchman, Senior Vice President, Medical and Clinical Affairs & Chief Medical Officer of Oncolytics. "These findings support previous evidence of REOLYSIN being active in cancer cells with an activated RAS pathway and warrants confirmation of KRAS status as a potential predictive biomarker in future studies."

The study was an open-label, multi-institution, two-arm phase 2 randomized study of patients with metastatic pancreatic cancer. Patients were randomized to receive either carboplatin, paclitaxel plus REOLYSIN (test arm) or carboplatin and paclitaxel alone (control arm). Patients in both arms received treatment every three weeks (21-day cycles) and standard intravenous doses of paclitaxel and carboplatin on day one only. In the test arm, patients also received intravenous REOLYSIN at a dose of 3x1010 TCID50 on days one through five. Tumor response assessment was done by computed tomography (CT) scan and conducted every eight weeks. Patients who progressed on carboplatin and paclitaxel (control arm) had REOLYSIN added. If patients experienced significant toxicity related to carboplatin and/or paclitaxel, they could continue with single agent REOLYSIN.

The primary endpoint of the trial is to assess improvement in progression-free survival with REOLYSIN, carboplatin and paclitaxel relative to carboplatin and paclitaxel alone in patients with metastatic pancreatic cancer. The primary endpoint is progression free survival in both arms. Secondary endpoints include safety, overall response rate, overall survival, immune factors and to prospectively establish and validate the relationship between Ras mutations in tumor samples and response to REOLYSIN.

Facebook (FB) Announces Expanded Analytics Tools for App Developers Sep 16, 2014 05:14PM

Facebook (NASDAQ: FB) posted the following to its official Developer blog on Tuesday:

Today we're excited to announce that we're launching new tools within App Insights to let you better measure the performance of your app among specific groups of people, and better track retention of people using your app. App Insights allows you to measure Facebook integrations, traffic sources, and specific events taken within your app. Now, these additions will make it easier for you to make smart business decisions to improve the performance of your app.

Understand the performance of your app by cohort

First, we've made it easier for you to understand the performance of your app by introducing label cohorts. Label cohorts allow you to categorize groups of people who use your app and measure important factors, like revenue or time spent in the app. For example, you can create label cohorts to automatically follow a group of people who installed your app from a specific ad set, so you can understand how much time that group spent in your app and how much money they spent through in-app purchases.

Another key benefit is the ability to A/B test various tactics. With label cohorts you can test different tactics with two different groups and then measure which performs best. For example, you can provide 10 percent of people with a free item within your app, and then measure whether that group spends more than people who didn't get the free item. This is just one of the many strategies this new insight can unlock - it gives you the flexibility to define your own cohorts, which makes App Insights more powerful in building your apps and measuring growth.

Below are some examples of the type of label cohorts a developer could use:

  • Install source cohorts - You can group people by the source from which they installed an app, e.g. Facebook Ad, organic, request, etc. and measure which source brings you the people who spend the most.
  • Action-based cohorts - You can group people who have taken a certain action in your app. For instance, this could be a group of people who've reached a certain level in your game, so you can compare that group to a group that's reached a different level to see who spends more.
  • Time-based cohorts - You can group people who have installed your app in a specific time frame. For instance, you could compare people who installed in June versus July, and see which group spends more time in your app for each month.
  • Story-based cohorts - You can track impressions that you receive from posts to Facebook by people within a particular group, allowing you to determine which groups post the most, or which post the most successful stories back to Facebook.
  • Create your own - This is a flexible system that allows you to test downstream actions and conversion events for groups of people using your app based on whatever criteria you choose.

*Note App Events insights are only available to those who have instrumented app events with the Facebook SDK.

Understand how well you're retaining people in your app

Second, we created a visual way for you to measure how people use your app, based on when they installed it. Our new App Event retention charts will show you what percentage of people took an action for any number of days after installing the app, up to 14 weeks after the install date. With this data, you can determine if certain changes you made to your app resulted in a significant change in engagement. From there, you have the option to run ads or make other changes as a result of knowing this granular, time-specific information. In order to take advantage of this feature, you must be logging App Events with Facebook.

One way to take advantage of this is with the 'app activate' event, which registers a session each time someone opens your app. For example, if a large percentage of the people who installed your app on July 18th continued to open the app ('activate app') for several days after installing, you can then use this information to understand what may have caused the increase (or decrease) in retention. For instance, you could measure the impact a sale or an app update had on retention of people using your app.

The retention chart is available for all the events you log. If you are also logging purchases, you can see what percent of people are making purchases on the day they installed the app, and what percent of people are making purchases on any number of days (up until 14 weeks) after installing the app. If your app is logging 'level 20 complete', you can see the percentage of people who completed level 20 after day 60 to understand how difficult your app might be. All of these insights will now enable you to enhance your current app strategies to improve the performance of your app.

Getting Started with App Events, Now Available For Apps on Facebook

You can get these new insights for both apps on Facebook and native mobile apps. We highly recommend that in order to fully take advantage of these new features that you instrument [App Events] (https://developers.facebook.com/docs/platforminsights/appevents) for all of your downstream conversion events. And starting today, , we are excited to share that App Events is now available for apps on Facebook. This means that you can now measure the activity within your apps on Facebook, run desktop app ads for your highest purchasers and measure the features mentioned above. Start using app events for your apps on Facebook by using our Javascript SDK. For mobile apps, install our Facebook SDK and implement app events to start taking advantage of all these features.

YRC Worldwide (YRCW) Enters Amended Credit Agreement; Offers Q3 adj.-EBITDA, Op. Income Outlook Sep 16, 2014 05:12PM

YRC Worldwide (NASDAQ: YRCW) announced that it has launched an amendment to its Term Loan Credit Agreement (the "Credit Agreement") to revise its leverage ratio covenant from the third quarter of 2014 through the fourth quarter of 2016.

"During the first half of the year, revenue has kept pace with our forecast, however, the harsh winter season in the first quarter of this year and subsequent network inefficiencies at YRC Freight in the second quarter of this year resulted in lower than originally anticipated productivities," said James Welch, chief executive officer of YRC Worldwide, "and the rate of improvement at YRC Freight is taking longer to materialize than expected. The Regional carriers, on the other hand, continue to perform near expected levels and in the range of the market's margins. While we project to be in compliance with our third quarter leverage ratio covenant, we are launching the amendment now to take uncertainty out of the market and to allow the company to continue making progress on its performance and yield improvement plans," stated Welch.

"Our progress in the third quarter can be measured by yield and tonnage increases at both YRC Freight and the Regional segment. YRC Freight reported total revenue per hundredweight increases of 2.8% in July and 3.3% in August," Welch continued. "It also reported tonnage per day increases of 2.4% in July and 0.8% in August. The Regional segment reported total revenue per hundredweight increases of 1.5% in July and 0.6% in August and reported tonnage per day increases of 4.2% in July and 3.7% in August. We are continuing to experience these same trends in the month of September at each of our operating segments," concluded Welch.

"As a result of the performance initiatives and positive yield results thus far in the quarter, we anticipate reporting Adjusted EBITDA (defined as Consolidated EBITDA in the Credit Agreement) of approximately $75 million to $80 million and operating income of approximately $22 million to $27 million for the third quarter of this year," said Jamie Pierson, chief financial officer of YRC Worldwide. "This projected Adjusted EBITDA is approximately $13 million to $18 million higher than our reported Adjusted EBITDA for third quarter 2013 of $61.8 million and our projected operating income is approximately $16 million to $21 million higher than our reported operating income from third quarter 2013. With this amendment, we plan to focus on our operations and the positive momentum we have built so far this quarter. We appreciate the support of our lenders and believe that the successful completion of this amendment will affirm their confidence in our ongoing initiatives and the future of YRCW," Pierson stated.

Education Management (EDMC) to Delay 10-K Filing Sep 16, 2014 05:07PM

Education Management (NASDAQ: EDMC) will delay its 10-K filing with U.S. SEC. The company provided the following narrative:

"We are unable to timely file our Report on Form 10-K for the fiscal year ended June 30, 2014 without unreasonable effort or expense due to unresolved comments from the Division of Corporation Finance of the Securities and Exchange Commission (the “SEC”) related to our revenue recognition and related bad debt reserve recorded upon student withdrawals from school. We intend to file our June 30, 2014 Form 10-K upon resolution of these remaining comments raised by SEC."

Abiomed (ABMD) Updates on RECOVER RIGHT Clinical Trial Results Sep 16, 2014 05:05PM

Abiomed (Nasdaq: ABMD) announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella RP™ (Right Percutaneous) System. The clinical trial results demonstrated a survival rate of 73% in the overall patient population.

RECOVER RIGHT was an FDA-approved, prospective, multicenter, single arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with right ventricular failure (RVF) refractory to medical treatment and deemed to require hemodynamic support.

The 30 patients enrolled in the RECOVER RIGHT trial were categorized into two patient cohorts. Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device (LVAD). Cohort B examined patients who developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction (AMI) shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.

Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B had a 58.3% survival rate at 30 days.

"Right-side heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively. The data from this trial is encouraging, and demonstrates that the Impella RP may play a pivotal role in the treatment of RVF patients in need of hemodynamic support in the future here in the U.S.," said William O'Neill, M.D., co-principal investigator for the RECOVER RIGHT trial and medical director of structural heart disease at Henry Ford Hospital.

"The Impella RP is the first percutaneous, single vascular access pump designed for right heart support. The pump is designed to be used concurrently with other left ventricle pumps in the Impella platform, which in the future may offer physicians the option of percutaneous biventricular support for acute patients," said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.

"The trial results were favorable and the 30-day outcomes appear promising compared with clinical data from surgical RV assist devices; however our study was not designed for a statistical comparison. Overall, the results show that the percutaneous approach with Impella RP potentially offers significant advantages to patients," said Mark Anderson, M.D., co-principal investigator for the RECOVER RIGHT trial and chair of the division of cardiothoracic surgery at Einstein Medical Center.

The trial results, "A Prospective, Multicenter Study to Evaluate a New Percutaneous Ventricular Assist Device for Right Ventricular Failure: The RECOVER Right Study," were presented today by Dr. O'Neill at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) 2014 scientific meeting in Washington, DC.

The Company also announced last week that it has completed its FDA submission of RECOVER RIGHT trial data for the Human Device Exemption (HDE) submission.

*The Impella RP is the subject of an investigational device exemption (IDE) clinical study and is limited by federal law to investigational use. The Impella RP currently is not available for sale in the United States.

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