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Trubion Pharmaceuticals (TRBN)
Q2 2008 Earnings Call
August 08, 2008 5:00 pm ET
Executives
Jim DeNike - Senior Director, Corporate Communications
Dr. Peter Thompson - President, Chief Executive Officer and Chairman
Michelle Burris - Senior Vice President and Chief Financial Officer
Dr. Ken Mohler - Senior Vice President of Research & Development
Presentation
Operator
Good afternoon ladies and gentlemen and welcome to the Trubion Second Quarter and First Half 2008 Earnings Conference call. My name is Tony and I will be your conference call coordinator today. Today's call is being recorded.
At this time, I would like the turn the call over to Trubion Senior Director of Corporate Communications Jim DeNike. Please go ahead sir.
Jim DeNike - Senior Director, Corporate Communications
Thanks Tony and thanks to everyone for joining us. On the call today from Trubion is Dr. Peter Thompson, President, Chief Executive Officer and Chairman. Also joining the call for the Q&A are Michelle Burris, Senior Vice President and Chief Financial Officer and Dr. Ken Mohler, Senior Vice President of Research & Development.
Earlier today we issued our second quarter 2008 financial results. And a copy of the press release can be found on the Trubion website at trubion.com. I’d like to remind you each of you that today’s conference call may contain forward-looking statements based on our current expectations. These statements are only predictions and actual results may vary materially from those projected. Please refer to Trubion’s documents filed with the SEC concerning factors that could affect the company, copies of which are also available on our website, Peter.
Dr. Peter Thompson - President, Chief Executive Officer and Chairman
Thank you Jim and thanks to all of you for joining us today. On the call I will provide a review of Q2 milestones and outline our continued progress on initiatives that are advancing our pipeline.
Since most of you have already had a chance to review the financials and guidance as described in the press release we will not repeat them on this call but Michelle Burris , our CFO will be available to take your questions as needed.
In Q2 the Trubion continue to develop our pipeline of candidates for autoimmune inflammatory diseases in cancer. In June we announced that Wyeth exercised its option under the terms of its collaboration agreement with Trubion to extent of a search period for an additional one year period through December 22, 2009.
Under the terms of the research period extension Wyeth’s obligations to Trubion include collaboration of such funding commitment of approximately $3.2 million and exchange for committed research services through December 22, 2009. Wyeth’s ongoing commitment to the collaboration underscores the potential of our technology and we look forward to continuing our efforts Wyeth as we persuade a development of first-in-class, investing class compounds with them.
Also in June positive data was presented on both TRU-016 and SBI-087 at the Annual European Congress of Rheumatology or EULAR meeting in parallel. These data demonstrated that repeated ministration of TRU-015 Trubion’s lead candidate for the treatment of Rheumatoid arthritis continues to produce persistent responses as measured by the ATR criteria, inconsistent pharmacodynamic effect. In addition, preclinical data presented at the meeting demonstrated that a single dose of SBI-087 are next generation small modular immuno pharmaceutical treatment for RA resulted in more potent B-cell depletion in peripheral blood and lymphoid tissue than rituximab.
During the second quarter we also announced the initiation of two new clinical trials being conducted by our partner Wyeth. A Phase 2b study of TRU-015 and RA and a Phase 1 study of SBI-087 and RA as well. Patient dosing commenced in may for the TRU-015 Phase 2b study, we expect to enroll approximately 216 patients with active seropositive RA on a background of methotrexate, as we previously reported and designed in a way that we believe could be supportive of a registration package with the FDA to response symptoms education.
In April we announced that Wyeth has initiated a Phase 1 dose escalation clinical trial for SBI-087 it has designed to study that Phase B tolerability pharmacokinetics and pharmacodynamic of a single dose of SBI-087 and patients with RA. The positive data we are seeing today it reinforces our belief that TRU-015 and SBI-087 will play important role in improving patient care and helping us to establish category leadership in autoimmune and inflammatory disease market. We will continue to update you as new data is available and as new milestones are reached.
Clinical and preparatory pipeline in June represented positive preclinical data at the American Society of Clinical Oncology or ASCO Annual meeting in Chicago on TRU-016. Data from both in vivo and in vitro studies showed that TRU-016 has Potent Anti-Tumor activity and induces signification long term tumor eradication in tumor xenograft models in which Rituxan has failed to induce durable responses.
Moreover, TRU-016 treatment produced Anti-Tumor activity that resulted an increase survival and a significant delay in tumor growth in non-Hodgkins lymphoma xenograft.
As many of you may recall we initiated a Phase 1 2 clinical trial in March that will study the safety tolerability pharmacokinetics and estimated clinical activity of TRU-016 for patients with Chronic Lymphocytic Leukemia. Patient dosing is underway and we look forward to reporting results when the trial is complete.
In addition to our progress in the clinic or the SMIPtm Therapeutics we continue to develop our Scorpion enhanced technology which we introduced on our last earnings call on May. These technologies are into broadening our preparatory pipeline of differentiated product candidates. Scorpions are novel single chain polypeptides comprised of functional domains from naturally occurring Hurricane. These are multi specific therapeutics that are capable of targeting two or more antigen simultaneously. We believe Scorpions have a potential to offer significant advantages in safety and efficacy over existing modest specific in Byron therapy.
Our true enhanced technology is capable of markedly enhancing the potency of existing therapeutics that works for FC directed or Antibody Directed Cellular Cytotoxicity or ADCC. As we previously shared this effective mechanisms is known to be an important determinant of efficacy for some immuno pharmaceuticals and oncology indication which has led the great interest in developing methods for enhancing ADCC potency. We believe that our simple preparatory true enhanced manufacturing methodology can generate product candidates with greater a large increase in ADCC potency with preserve longing people half life. We will continue to provide additional information on these exciting technology design new candidates, incorporating them or selected and timelines are finalized. That concludes our update and I would once again like to thank all you for joining us today.
As I mentioned in my opening, I repeat that our press release issued earlier today for a detailed discussion of our second quarter financials and 2008 guidance. As we open the call to question, I would like to remind you that Michelle Burris and Dr. Kendall Mohler, who runs R&D for our organization are available for questions as needed. Operator, please go ahead.
Question-and-Answer Session
Operator
Thank you, sir. (Operator Instructions).
And it appears as though we have no questions signaling at this time. Do we have any closing comments from Dr. Thompson?
Peter Thompson
I would like to thank you again for your continued interest and support of Trubion and we look forward to speaking with you again soon.
Operator
This does conclude today's conference. We do thank you very much for your participation. You may disconnect at this time.
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