Click here to close now.

SYS-CON MEDIA Authors: Liz McMillan, Elizabeth White, Dana Gardner, tru welu, Blue Box Blog

News Feed Item

Adherex Provides Corporate Update and First Quarter Ended March 31, 2014 Financial Results

RESEARCH TRIANGLE PARK, NORTH CAROLINA -- (Marketwired) -- 05/15/14 -- Adherex Technologies Inc. (TSX: AHX)(OTCQB: ADHXF) today reported its financial results and recent developments for the first quarter ended March 31, 2014. All amounts are in US dollars unless otherwise specified.

As reported, the two Phase 3 clinical trials studying Sodium Thiosulfate (STS) for prevention of hearing loss in children receiving cisplatin chemotherapy have been accepted for presentation at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The US based Children Oncology Group (COG) ACCL0431 study completed enrollment of 135 patients in February 2012. David Freyer, DO, MS, Childrens Hospital Los Angeles, COG ACCL0431 Study Chair, will present, "The Effects of Sodium Thiosulfate (STS) on Cisplatin-induced Hearing Loss: A Report from the Children's Oncology Group," in an oral presentation on June 1, 2014. The European based SIOPEL 6 study, "A Multicenter Open Label Randomized Phase III Trial of the Efficacy of Sodium Thiosulfate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma," has been accepted for the "trials in progress" poster session on June 2, 2014. Edward A. Neuwelt, M.D., Professor at Oregon Health & Science University, will present the poster on behalf of the SIOPEL 6 investigators and support team.

The enrollment of SIOPEL 6 Study is almost complete, as 103 patients have been randomized. The first three interim safety analyses were conducted after 20, 40 and 60 patients, and in each case, the Independent Data Monitoring Committee (IDMC) recommended continuation of the study. An additional interim safety analysis for 80 patients is expected to be performed shortly.

Financial Update

Cash and cash equivalents totaled $1.3 million at March 31, 2014, compared to $1.7 million at December 31, 2013. At March 31, 2014, the Company had working capital balance totaling approximately $1.2 million compared to $1.4 million as of December 31, 2013.

The Company reported a net loss from operations of $0.5 million excluding the $2.7 million non- cash loss on derivatives for the first quarter ended March 31, 2014, compared to a net loss from operations of $0.5 million excluding the non-cash gain of $3.6 million in the same period in 2013. Operating net loss for the quarter ended March 31, 2014 remained the same as compared to the first quarter in 2013. There was a large reduction in research and development expenses over the same period in the prior year, however this reduction was offset by the increase in general and administrative expenses associated with our November 2013 financing.

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim consolidated financial statements for the period ended March 31, 2014 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com.


                         Adherex Technologies Inc.
                          Selected Financial Data
            (U.S. Dollars in thousands except per share amounts)

                                                    March 31,  December 31,
                                                         2014          2013
Interim Unaudited Condensed Consolidated Balance
 Sheets:
Assets:
Cash and cash equivalents                               1,338         1,663
Other current assets                                       57            89
                                                    ------------------------
Total assets                                            1,395         1,752
                                                    ------------------------
                                                    ------------------------

Liabilities and stockholders' equity:
Current liabilities                                       211           344
Derivative liabilities                                  5,518         2,863
Other long-term liabilities                                 -             -
Total stockholders' equity                             (4,334)       (1,455)
                                                    ------------------------
Total liabilities and stockholders' equity
 (deficiency)                                           1,395         1,752
                                                    ------------------------
                                                    ------------------------

----------------------------------------------------------------------------
----------------------------------------------------------------------------

                                                         Three Months Ended
                                                    ------------------------
Interim Unaudited Condensed Consolidated            March 31,     March 31,
 Statements of Operations:                               2014          2013
                                                    ------------------------


Revenue                                              $      -  $          -
Operating expenses
  Research and development                                 32           178
  General and administrative                              505           359
                                                    ------------------------
Loss from operations                                     (537)         (537)
                                                    ------------------------
  Unrealized (loss)                                    (2,655)       (3,573)
  Interest (expense)/income and other                      (2)            2
                                                    ------------------------
Net (loss) and comprehensive (loss)                  $ (3,194) $     (4,108)
                                                    ------------------------
                                                    ------------------------

Basic and diluted net loss per common share          $  (0.11) $      (0.16)
                                                    ------------------------
                                                    ------------------------

Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013. Adherex Technologies, Inc. disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

About Sodium Thiosulfate (STS)

STS is a chemoprotectant being developed by Adherex to reduce or prevent hearing loss in oncology patients resulting from treatment with platinum-based chemotherapy drugs. The initial focus is on the pediatric market. Hearing loss following cisplatin exposure affect approximately 2,000 children in the US every year. STS has received Orphan Drug Designation in the United States for the prevention of platinum-based ototoxicity in pediatric patients. In addition, Adherex has licensed intellectual property rights for the use of STS as a chemoprotectant from Oregon Health & Science University.

STS is a water-soluable thiol compound and acts as a chemical reducing agent. It is FDA approved for the treatment of cyanide poisoning and has been used in oncology to prevent cisplatin nephrotoxicity. It is thought that hearing loss caused by platinum compounds result from the deposition of protein-bound platinum in the cochlea and STS binds platinum/protein complexes thereby potentially minimizing their toxicity. At a bolus dose of 20 g/m2 over 15 minutes, STS has sufficient high plasma concentrations to rapidly, covalently bind to any residual extracellular cisplatin and thereby possibly prevent ototoxicity. Because STS is to be administered six hours after cisplatin, antitumor efficacy of cisplatin should not be compromised.

About STS Clinical Studies

Study ACCL0431: "A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children", conducted by the Children's Oncology Group (COG), finished enrollment of 135 patients in Q1 2012. These patients had been previously diagnosed with one of five rare childhood cancers typically treated with intensive cisplatin therapy, including hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.

SIOPEL 6: "A Multicenter Open Label Randomized Phase III Trial of the Efficacy of Sodium Thiosulfate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma" is being conducted by The International Childhood Liver Tumor Strategy Group, SIOPEL. As of this date, the study has enrolled 103 patients. SIOPEL 6 is studying STS in standard risk hepatoblastoma patients where the effectiveness of the platinum treatment is known to be very high.

Contacts:
Adherex Technologies Inc.
Rosty Raykov
Chief Executive Officer
(919) 636-5144

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
The consumption economy is here and so are cloud applications and solutions that offer more than subscription and flat fee models and at the same time are available on a pure consumption model, which not only reduces IT spend but also lowers infrastructure costs, and offers ease of use and availability. In their session at 15th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed this shifting dynamic with an ...
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackI...
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT transformation?
The recent trends like cloud computing, social, mobile and Internet of Things are forcing enterprises to modernize in order to compete in the competitive globalized markets. However, enterprises are approaching newer technologies with a more silo-ed way, gaining only sub optimal benefits. The Modern Enterprise model is presented as a newer way to think of enterprise IT, which takes a more holistic approach to embracing modern technologies.
For better or worse, DevOps has gone mainstream. All doubt was removed when IBM and HP threw up their respective DevOps microsites. Where are we on the hype cycle? It's hard to say for sure but there's a feeling we're heading for the "Peak of Inflated Expectations." What does this mean for the enterprise? Should they avoid DevOps? Definitely not. Should they be cautious though? Absolutely. The truth is that DevOps and the enterprise are at best strange bedfellows. The movement has its roots in t...
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
There's no doubt that the Internet of Things is driving the next wave of innovation. Google has spent billions over the past few months vacuuming up companies that specialize in smart appliances and machine learning. Already, Philips light bulbs, Audi automobiles, and Samsung washers and dryers can communicate with and be controlled from mobile devices. To take advantage of the opportunities the Internet of Things brings to your business, you'll want to start preparing now.
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
In a world of ever-accelerating business cycles and fast-changing client expectations, the cloud increasingly serves as a growth engine and a path to new business models. Dynamic clouds enable businesses to continuously reinvent themselves, adapting their business processes, their service and software delivery and their operations to achieve speed-to-market and quick response to customer feedback. As the cloud evolves, the industry has multiple competing cloud technologies, offering on-premises ...
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
Over the years, a variety of methodologies have emerged in order to overcome the challenges related to project constraints. The successful use of each methodology seems highly context-dependent. However, communication seems to be the common denominator of the many challenges that project management methodologies intend to resolve. In this respect, Information and Communication Technologies (ICTs) can be viewed as powerful tools for managing projects. Few research papers have focused on the way...