Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

CTI Readies Pixuvri® European Launch and Start of Pacritinib Phase 3 Trial

Published: Monday, December 31, 2012
Last Updated: Monday, December 31, 2012
Bookmark and Share
European launch of Pixuvri® targeted for Q4 2012.

Cell Therapeutics, Inc. has reported financial results and recent accomplishments for the second quarter of 2012.

Recent Company Highlights

• European Commission grants conditional marketing authorization for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL").
• Steven E. Benner, M.D., M.H.S. named new Executive Vice President and Chief Medical Officer.
• Closed the acquisition of pacritinib, a highly selective JAK2 inhibitor, scheduled to enter phase 3 clinical trial for treatment of patients with myelofibrosis ("MF") in Q4 2012.
• Targeting cut in net operating burn rate from an average of $6.5 million per month to an average of $4.5 million per month for remainder of 2012 and focusing on commercial launch of Pixuvri and advancing phase 3 programs.

"Based on in-market research among more than 250 lymphoma specialists in the five major market countries in the European Union ("EU"), we are encouraged by the interest and potential adoption of Pixuvri for treatment," stated James A. Bianco, M.D., President and CEO of CTI.

Bianco continued, "We believe we can present an argument for Pixuvri to provide fair pricing reimbursement in an effort to address the commercial potential of Pixuvri in the E.U. On the heels of our projected fourth quarter launch of Pixuvri in the E.U., we expect to start pivotal studies of our recent JAK2 product acquisition, pacritinib. In the meantime, we are also advancing tosedostat toward its phase 3 clinical trial."

Financial Results

For the quarter ended June 30, 2012, total operating expenses were $49.4 million compared to $16.9 million for the same period in 2011. The increase is predominantly due to an acquired in-process research and development expense of $29.1 million relating primarily to the acquisition of pacritinib from S*BIO Pte Ltd. ("S*BIO"), in addition to equity-based compensation and expenses related to preparation for commercialization of Pixuvri in the E.U.

Net loss attributable to common shareholders was $58.6 million ($0.28 per share) for the quarter ended June 30, 2012 compared to a net loss attributable to common shareholders of $22.5 million ($0.14 per share) for the same period in 2011.

The increase in net loss attributable to CTI's common shareholders is primarily due to an increase in non-cash deemed dividends on preferred stock issuances and operating expenses, which includes the acquisition of pacritinib from S*BIO.

For the six months ended June 30, 2012, total operating expenses were $67.5 million compared to $37.0 million for the same period in 2011. Net loss attributable to common shareholders was $76.0 million ($0.37 per share) for the six months ended June 30, 2012 compared to a net loss attributable to common shareholders of $73.5 million ($0.47 per share) for the same period in 2011. The increase in net loss attributable to CTI's common shareholders is primarily due to an increase in total operating expenses, which includes the acquisition of pacritinib from S*BIO.

CTI had approximately $14.8 million in cash and cash equivalents as of June 30, 2012. This amount was before the receipt of $15 million in gross proceeds received from the sale of CTI's Series 15-2 convertible preferred stock and warrants in July 2012 as part of a $35 million financing.

As previously announced, CTI completed the first closing of $20 million of Series 15-1 convertible preferred stock and warrants in May 2012.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

CTI Opens Enrollment for PERSIST-2 Phase 3 Trial of Pacritinib for Myelofibrosis Patients
This trial, together with PERSIST-1, to support registration in the U.S. and Europe.
Tuesday, March 04, 2014
CTI Announces UK NCRI AML Cooperative Group Phase 2 Trial Evaluating Pacritinib for AML Patients
Trial sponsored by Cardiff University and supported by Cancer Research UK.
Tuesday, February 04, 2014
CTI Announces GOG Completes Patient Enrollment in GOG-0212
Patient enrollment in Phase 3 clinical trial of Opaxio™ as maintenance therapy in ovarian cancer.
Thursday, January 30, 2014
CTI Reaches Agreement with Novartis
Agreement to reacquire rights to two anti-cancer compounds.
Monday, January 13, 2014
CTI Announces Removal of the Partial Clinical Hold on Tosedostat
Company has received notification from the U.S. Food and Drug Administration.
Thursday, January 02, 2014
CTI and GKV-SV Reach Agreement on Pricing of PIXUVRI® (pixantrone) in Germany
Decision applies to patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy.
Wednesday, December 04, 2013
CTI Announces Data Presentations at the 55th ASH Annual Meeting
Pacritinib phase 2 analysis of myelofibrosis patients with thrombocytopenia (low platelets) accepted for oral presentation.
Monday, November 11, 2013
Cell Therapeutics Announces Agreement with the FDA on SPA for PERSIST-2 Trial
PERSIST-2 trial expected to initiate in fourth quarter of 2013.
Tuesday, October 08, 2013
Market Access Granted in France for Aggressive NHL Treatment, PIXUVRI®
CT will reassess the ASMR rating for PIXUVRI within two years.
Wednesday, August 21, 2013
CTI Announces Results from Sub-Set Analyses of Data from Phase 3 EXTEND Clinical Trial
Results presented at 18th Congress of the European Hematology Association.
Monday, July 15, 2013
Market Access Granted in Italy for PIXUVRI®
Access granted by AIFA for the aggressive non-Hodgkin lymphoma treatment.
Monday, July 08, 2013
Comprehensive Summary of Preclinical and Clinical Data for Pacritinib Published
Comprehensive article was published in the journal Drugs of the Future 2013.
Thursday, July 04, 2013
Cell Therapeutics Announces Resignation of Chief Medical Officer
Resignation of Steven E. Benner for personal reasons.
Monday, July 01, 2013
CTI Secures $15 Million Loan Financing Agreement
Company has entered into loan agreement with HTGC.
Tuesday, May 28, 2013
G-BA Issues Final Assessment Report for PIXUVRI®
Pricing negotiations to begin in June.
Tuesday, May 21, 2013
Scientific News
Advanced Lymphoma in Remission After T-Cell Therapy
63% of trial participants who recieved two-drug combination chemo plus intermediate dose of engineered T cells went into complete remission.
New Treatment for Immune Cancers
Clinical trial shows new drug holds promise for treating advanced mastocytosis.
Sickle Cell Gene Therapy Passes Test
Researchers found a precision-engineered gene therapy virus reduced sickle-induced red-cell damage in mice with sickle cell disease.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Inovio Launches Zika Vaccine Trial
Inovio launches Zika vaccine trial in midst of Puerto Rico epidemic to explore early signals of vaccine efficacy.
Vitamin C May Boost Leukemia Treatment
Studies show that supplementing an epigenetic cancer drug with vitamin C enhanced the drug's effectiveness.
New Hope for Zika Treatment Found in Large-Scale Screen of Existing Drugs
Johns Hopkins researchers join collaborative group to screen 6,000 existing drugs in hopes of finding treatments for Zika Virus infection
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!