cheap moncler Cyclacel Pharmaceuticals’ CYCC CEO Spiro Rombotis on Q1 2015 Results

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Cyclacel Pharmaceuticals’ CYCC CEO Spiro Rombotis on Q1 2015 Results

Good afternoon and welcome to the Cyclacel Pharmaceutical’s First Quarter 2015 Earnings Conference Call and Webcast. Today’s call is being recorded. At this time, all participants have been placed in a listen only mode and the floor will be opened for questions following the presentation. [Operator Instructions].

It is now my pleasure to turn the floor over to Bill Harris, Cyclacel’s Corporate Controll

Cyclacel Pharmaceuticals’ CYCC CEO Spiro Rombotis on Q1 2015 Results

Good afternoon and welcome to the Cyclacel Pharmaceutical’s First Quarter 2015 Earnings Conference Call and Webcast. Today’s call is being recorded. At this time, all participants have been placed in a listen only mode and the floor will be opened for questions following the presentation. [Operator Instructions].

It is now my pleasure to turn the floor over to Bill Harris, Cyclacel’s Corporate Controller. Sir, you may begin.

Thank you. Good afternoon and welcome to our quarterly conference call. During today’s call, members of our senior management team will review Cyclacel’s financial performance and business highlights for the first quarter ended March 31, 2015.

Before turning the call over to senior management, I would like to remind everyone that during this conference call, any forward looking statements made by management are intended to fall within the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended.

As set forth in our press release, forward looking statements involve risks and uncertainties that may affect the company’s business and prospects, including those discussed in our filings with the SEC, which include, among other things, our Form 10 K. These filings are available from the SEC or our website.

All of our projections and other forward looking statements represent our judgment as of today and Cyclacel does not take any responsibility to update such information.

With us today are Spiro Rombotis, President and Chief Executive Officer; Paul McBarron, Executive Vice President, Finance and Chief Operating Officer; and Dr. Judy Chiao, Vice President of Clinical Development and Regulatory Affairs.

At this time, I would like to turn the call over to Spiro Rombotis, our President and CEO.

Thank you, Bill, and thank you all for joining our quarterly call. As many of you know, we have completed enrollment in SEAMLESS, our Phase 3 trial of oral sapacitabine capsules as a frontline treatment of patients aged 70 years or older with acute myeloid leukemia or AML who have refused or aren’t fit for intensive chemotherapy.

The study is in the firm out [ph] phase and we’re encouraged that investigators continue to treat and/or follow up patients as appropriate. The primary end point of this trial is overall survival. SEAMLESS were sized for approximately 485 patients and was powered at 90% to detect an improvement of survival against an active controller arm of intravenous decitabine.

The trial design re specifies that 424 events need to be observed in order to unblind the data. Approximately 20% of these events remain to be observed before mature data becomes available for analysis.

Overall reliable estimation of when data maturity will be reached is difficult. We continue to conservatively estimate that we will reach the specified number of events between the second half of 2015 and the first half of 2016. At that point we will break the randomization code and evaluate the data.

As a reminder, on previous calls, we have discussed the outcome of the interim analysis for futility. We believe it is important not to judge the final outcome of clinical studies based on interim data. Our view remains that the decision to submit a dossier for regulatory approval will depend on the totality of the data and their clinical relevance in this patient population.

We believe that decitabine’s European approval is a frontline treatment in AML maybe relevant to our assessment of submissibility of the SEAMLESS data. Planning for potential regulatory submissions, we’re in the process of preparing a pediatric investigational plan for sapacitabine for submission to the European Medicines Agency.

Let us now turn to the other exciting developments with regard to our Cyclin Dependent Kinase or CDK inhibitor program. A decade and half since the award of a Nobel Prize for medicine and physiology for the discovery of CDKs and checkpoint control of cancer cells, they’re finally emerging as a major therapeutic class of anti cancer agents.

Because of their function, and cell cycle checkpoint inhibitors, drug targeting CDK enzymes have been recently elevated through a high priority by clinical investigators and the pharmaceutical industry.

We have also witnessed this base on the number of incoming requests regarding our CDK program and in particular the high awareness of the properties of CYC065.

The FDA approval earlier this year of Pfizer’s palbociclib or Ibrance which is the first CDK inhibitor through which the market has reaffirmed the importance of the CDK class. Two other CDK inhibitors are abemaciclib from Lilly and ribociclib from Novartis are in Phase 3 developments. All three of these molecules target CDK4/6 enzymes. Pfizer and Novartis have highlighted their CDK programs as major value drivers in investor presentations.

It took a while but CDKs are now validated targets. We believe that our CDK inhibitor program and in particular CYC065 may also become an important value driver for Cyclacel.

Although in our public communications, we have concentrated on our most advanced programs related to sapacitabine, we have been quietly advancing our CDK portfolio with the objective of bringing to patients in need a novel treatment option.

To this end, we are happy to report that we have been cleared by the FDA to begin first insulin [ph] Phase 1 clinical trial of CYC065 under a company IND in patients with advanced solid cancers and lymphomas. This Phase 1 study will commence as soon as possible following Institutional Review Board or IRB approval.

Of note, development of the preclinical package supporting our IND submission for CYC065 has been mostly financed by non dilutive stockholder friendly grants awarded to Cyclacel by the United Kingdom government.

As a historical reminder, Cyclacel has been investing in the biology of cell cycle control and initial addition of CDK enzymes with small molecules since the founding of the company some 18 years ago.

Out of the approximately dozen CDKs known to science our founder Professor Sir David Lane, chose to focus on CDK2/9 enzyme inhibition as a promising anti cancer strategy. This was because this isoform profile results in death of cancer cells by apoptosis and disruption of their ability to copy errors in DNA by a process called transcription. This is a different anti cancer mechanism to event of CDK4/6 inhibitors.

Targeting CDK4/6 may result in cancer cells entering into a non lethal dormant condition called senescence which is implicated in the evolution of resistance. Senescent non proliferating cancer cells learned to bypass the effect of therapy by developing resistance mechanisms but ultimately make them immortal or impossible to kill. While the cancer relapses after the cells resume proliferating, patient prognosis is usually poor.

The rationale of our strategy to target CDK2/9 is to endure cell death via cell cycle checkpoint control. Obviously, dead cells cannot adapt to develop resistance and become immortalized.

In addition, our preclinical data show that CYC065 reverses sensitivity of cancer cells that have already become resistant to the effect of widely used targeted anti cancer drugs like trastuzumab or Herceptin. Even these benefits are also observed in clinical trials CYC065 may represent an important therapeutic alternative addressing a large market opportunity.

CYC065 targets CDK2/9 with nanomolar potency. Conveniently, it can be administered by both the intravenous and/or routes. Data from clinical IND enabling studies with 065 represented last month at the American Association of Cancer Research or AACR meeting. In these studies, CYC065 demonstrated inhibition of key cancer and leukemia survival mechanisms and cause death by apoptosis in cancer cells.

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torsdag 19 november

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Hockey heroes return

The Legendary Hockey Heroes are coming back to Kamloops. Players such as Glenn Anderson, Bryan Trottier, Bob Bourne, Larry Melnyk, Ron Flockhart and Warren Skorodenski, along with referee Kerry Fraser, will take on the Media All Stars at Interior Savings Centre on Jan. A portion of the proceeds from each ticket will go to the Royal Inland Hospital Foundation. Tickets are available at 1 800 268 7371 or at the door an hour before game time. The Chase Trojans and M

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The Legendary Hockey Heroes are coming back to Kamloops. Players such as Glenn Anderson, Bryan Trottier, Bob Bourne, Larry Melnyk, Ron Flockhart and Warren Skorodenski, along with referee Kerry Fraser, will take on the Media All Stars at Interior Savings Centre on Jan. A portion of the proceeds from each ticket will go to the Royal Inland Hospital Foundation. Tickets are available at 1 800 268 7371 or at the door an hour before game time. The Chase Trojans and Merritt Panthers split a pair of junior basketball games in Chase on Wednesday. The Panthers won the boys’ game 33 18 thanks to Braidon Schonwold’s nine points. Jess Johnson scored 11 for Chase. The Trojans girls got revenge, beating the Panthers 26 23. Nadja Hedrich scored eight points for Chase, with Taylor Carmichael getting eight points for Merritt. Jaida Wallat had 12 points to lead the Sa Hali Sabres junior girls basketball team to a 50 14 victory over the host Valleyview Vikings on Tuesday night. Riley Clark added six points to the winning effort. The South Kamloops Titans, who are ranked No. 5 in provincial senior AAA girls basketball, opened the Okanagan league season with an 84 45 victory over the Salmon Arm Jewels on Tuesday. Emma Wolfram had 32 points and 19 rebounds to lead South Kam, with Ashley Lamoureux scoring 15 points. Maya Olynyk added 13 points. The Titans are off to Edmonton for a weekend tournament. Mairi Sutherland scored 14 points as the South Kamloops Titans ran to a 57 16 victory over the host Ashcroft Rams in a junior girls basketball game Tuesday. Jana Wale also scored 11 points in the victory. Jessica Mazar scored nine points for the Rams. Riley Peterson and Lucas Kemp each scored twice as the Team 8 Ochocincos beat Team 5, 6 5 in a midget recreational hockey game Tuesday. Rylan Spence and Dallas Stachoski also scored for the Ochocinos, who split the goaltending between Michael Clements and Austin Peel. Justin Bartella had three helpers. Nathan Bymoen scored three times for Team 5, which got singles from Mitchell Bymoen and Quinton Ziegelmann and goaltending from Dylan Campbell and Connor Neurater.

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Facts Not Many People Know

There are many aspects in IELTS that people find surprising, usually when it hits them hard. It is quite a paradox the information is right there, available to everyone, yet people are still in the dark. Allow me to draw your attention to several facts you don’t want to be surprised about.

Usually extensive answer is considered a very good one, but not in IELTS. When instructions say "give one answer" or "answer in 3 words"

Facts Not Many People Know

There are many aspects in IELTS that people find surprising, usually when it hits them hard. It is quite a paradox the information is right there, available to everyone, yet people are still in the dark. Allow me to draw your attention to several facts you don’t want to be surprised about.

Usually extensive answer is considered a very good one, but not in IELTS. When instructions say "give one answer" or "answer in 3 words", it means "give us two answers or 4 words and we’ll fail you". The reason for this limit is quite simple and obvious there is not enough room for more than 3 words on Answer Sheet. By the way, articles "a" and "the" count as one word, while common assumption is that they don’t.

People tend to forget that they are graded by Answer Sheet and not by what they wrote in IELTS booklet. Any correct answer not copied to Answer Sheet will result in exactly 0 points. There is an option of submitting appeal and requesting to read your answers from the booklet, but it takes time and costs money.

Not many people think about what they are going to write with, pen or pencil. Yet there are rules: the Listening and Reading answers are to be written in pencil and Writing in pen. This is another example of how small details can be very significant in IELTS.

Writing and Speaking are graded differently from Listening and Reading. There is no half band grade, which means it is impossible to get 6.5 in either Writing or Speaking. The reason is the way examiners are currently trained, but hopefully it will change in the future (according to official IELTS site maybe even in 2007).

In Reading and Listening tests the spelling is important, meaning one can loose points for misspelled words. The best way to overcome the spelling problem is to copy words. In case of Reading, copying words from text is a very easy and natural thing to do. In Listening test, as simple as it may sound, it is best to write what you hear and not to rephrase. It is acceptable to skip words after all there is 3 words limit, as long as the important words are not substituted by their synonyms.

And at last some good news: starting from May 2006 candidates don’t need to wait 90 days to retake the test. The 90 day waiting period has been canceled to the joy of those who have no time to waste.

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Comodo Forum Sees Growth

Within its initial 12 months, the Comodo Forum members have grown to more than 23,000. Alexa, a Web information company which tracks Internet trends and data, reports that Comodo has consistently outranked its closest competitors in reach, rank and page views over the past 6 months.The Comodo Forum is a community that shares information and advice, as well as a venue where members can help shape the development of Comodo solutions. Sections within the Comodo

Comodo Forum Sees Growth

Within its initial 12 months, the Comodo Forum members have grown to more than 23,000. Alexa, a Web information company which tracks Internet trends and data, reports that Comodo has consistently outranked its closest competitors in reach, rank and page views over the past 6 months.The Comodo Forum is a community that shares information and advice, as well as a venue where members can help shape the development of Comodo solutions. Sections within the Comodo Forum are devoted to specific products and solutions, which draw user ratings and feedback, answer questions and generate dialogue. The forum gains nearly 50 new registrations and more than 160 posts per day. As of July 30, the Comodo Forum contained 76,000 total posts spanning over 9,700 topics.created the Comodo Forum hoping that it would evolve into a strong knit community that consisted of both our customers and others interested in online security, says Melih Abdulhayoglu, Comodo CEO and chief security architect. is a diverse community, and our members appreciate being an integral part of Comodo and its future. announced last week that that flower and floral products provider TulipWorld has chosen Comodo High Assurance Confidence Pak to deliver a high level of security to its customers during online transactions.

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torsdag 29 oktober

michael kors outlet uk the investment from Cisco is a significant validation of the company’s role in the data center hardware virtualization space

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Cisco Buys a Stake in Parallels

Web hosting and cloud software maker Parallels announced last week that networking giant Cisco had acquired an equity stake in the company, a move that will certainly enable the two companies to collaborate on the direction of their products around cloud services.

According to reports, the investment amounts to a small, 1 percent stake in Parallels, but gives Cisco a spot on the company’s board of directors. According to Parallels, the de

Cisco Buys a Stake in Parallels

Web hosting and cloud software maker Parallels announced last week that networking giant Cisco had acquired an equity stake in the company, a move that will certainly enable the two companies to collaborate on the direction of their products around cloud services.

According to reports, the investment amounts to a small, 1 percent stake in Parallels, but gives Cisco a spot on the company’s board of directors. According to Parallels, the deal will "strengthen inter company collaboration towards accelerating customer adoption of Parallels cloud service delivery products with Cisco cloud and data center infrastructure solutions."

While some reports say Parallels is "better known" for its desktop virtualization software, the investment from Cisco is a significant validation of the company’s role in the data center hardware virtualization space, and the importance of the Parallels platform to enabling the delivery of cloud services by service providers.

Cisco says in the announcement issued by Parallels that the deal is a move toward building a more efficient cloud delivery model for service providers, and an opportunity to fuel innovation internationally through Parallels’ presence in Russia and elsewehere.

A report from Business Insider points out that Cisco’s interest in Parallels may also reflect the company’s souring relationship with virtualization giant VMware around the data center.

Cisco is a big customer of the products of both VMware and its parent company EMC, and co investors with VMware in a data center hardware company called VCE. But that relationship was disrupted, writes Julie Bort, in the Business Insider piece, when VMware acquired software defined networking startup Nicara last summer.

Subscribe to WHIR Newsletters Get Our Exclusive Report on "The Hosting Infrastructure Ecosystem".

Since then, a series of movies have driven the wedge further between Cisco and VMware. Back in October, Cisco acquired cloud networking software company vCider, a move many described as a response to the Nicira deal, and released its own flavor of the open source OpenStack cloud software platform, a software platform that competes directly with VMware.

By getting involved with Parallels, Cisco is forging another relationship that could limit or eliminate the need for Cisco to rely on VMware’s virtualization tech as part of its data center hardware

Money aside, the benefits of the relationship to Parallels are less explicit, though Parallels CEO Birger Steen is quoted in the press release as saying that strengthening its partnership with Cisco is part of a focus on "offering an end to end solution for cloud service providers."

That could mean that Parallels sees the partnership with Cisco as an opportunity to build a hardware component into the set of virtualization, automation and other cloud platform tools it provides.

An interesting component of the various arrangements is the various companies’ relationships with the service provider space. While Cisco and EMC hardware products are generally considered "enterprise" hardware, they are well represented in service provider environments where compatibility with enterprise environments is important.

The same is true of VMware, though, as a platform, VMware has spent the last few years designing its solutions to better fit service provider environments. Parallels, on the other hand, has been focused on delivering its virtualization solutions as part of a broader platform that involves billing and automation solutions for service providers, with the company counting more than 5,000 service providers among its customers.

Talk back: What do you think the partnership means to Cisco and Parallels? Does Parallels’ technology have a role to play in Cisco’s hardware, or vice versa? Let us know in the comments.

Liam Eagle has worked as a contributor to the Web Host Industry Review since its inception in 2000, and as editor since 2003. He has been editor of the WHIR’s print magazine since its launch. His daily involvement in the gathering and reporting of Web hosting news and his regular interaction with Web hosting leaders gives him an uncommonly broad appreciation of the issues and tends facing the business. Through his WHIR blog, Liam spots Web hosting trends and offers opinions on the industry wide impacts of major developments and the motivation behind big announcements.

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måndag 19 oktober


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