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GTx, Inc. (GTXI)
Q3 2008 Earnings Call Transcript
November 6, 2008, 9:00 am ET
McDavid Stilwell – Director, Corporate Communications & Financial Analysis
Mitchell Steiner – CEO and Vice Chairman
Marc Hanover – President and COO
Joel Sendek – Lazard Capital Markets
Eric Schmidt – Cowen and Company
Howard Liang – Leerink Swann
Aaron Reames – Wachovia Capital Markets
Previous Statements by GTXI
» GTx Inc Q4 2008 Earnings Call Transcript
» GTx, Inc. Q2 2008 Earnings Call Transcript
» GTx Inc. Q1 2008 Earnings Call Transcript
I would now like to turn the presentation over to your host for today’s conference Mr. McDavid Stilwell, Director of Corporate Communications. Please proceed.
Thank you, and good morning. On behalf of GTx, I would like to welcome you to our third quarter 2008 conference call.
We released our results earlier this morning through the newswires. If you do not have a copy of the release and want one, you will find it on our web site at gtxinc.com. We’ll have a replay of this call available on our web site until November 20, 2008.
With me today are Dr. Mitchell Steiner, Vice Chairman and Chief Executive Officer, Marc Hanover, President and Chief Operating Officer, and Mark Mosteller, Chief Financial Officer.
Following this introduction, Dr. Steiner will highlight third quarter 2008 clinical and corporate development. Next, Mr. Hanover will briefly discuss our financial performance. Dr. Steiner will then make closing remarks and open the call for questions.
Before we begin, I’ll remind you that information discussed on this call may include forward-looking statements, and such statements are subject to the risks and uncertainties we discuss in detail in our reports filed with the Securities and Exchange Commission, including in our most recent quarterly report on Form 10-Q filed August 5, 2008. We expressly disclaim any obligation to release publicly any updates to forward-looking statements made during this call.
Now, I’ll turn the call over to Dr. Steiner.
Thank you, McDavid. Good morning and thank you for joining us today.
We continue to make strong progress. Barring a recent planned pre-NDA meeting with the FDA, we are on track to submit this quarter the NDA for toremifene 80 milligram for the prevention of fractures and treatment of other estrogen deficiency side effects. In the first quarter of next year, we expect to hear from the FDA whether the NDA would be processed under priority or standard review. Our European partner Ipsen is planning to submit the MAA for toremifene 80 milligrams to the EMEA early next year. We are also in discussions with potential partners for toremifene in Asia, Japan and the rest of the world.
In September at the annual meeting of the American Society for Bone and Mineral Research, we presented additional efficacy and safety analysis from the Phase III ADT clinical trial. One safety measurement was serum PSA. PSA is a sensitive marker of prostate cancer progression in men with advanced prostate cancer, and is followed closely by physicians and patients to monitor the underlying prostate cancer. Among men in the modified intent to treat population with a detectable serum PSA at base line, which is a PSA greater than or equal to one nanograms per mil, there were 27% fewer men with PSA progression in the toremifene 80 milligram group compared to placebo. This reduction was statistically significant. Also there were no differences in PSA progression among men with an undetectable PSA at base line.
In October, at the Chicago Supportive Oncology Conference, we presented a similar analysis of PSA safety data from those study subjects who where treatment compliant at least 80% of the time. In this analysis, there were 31% fewer men with PSA progression in the toremifene 80 milligram group compared to placebo. We also presented at the same conference bone scan safety data and then a subset analysis of 201 men with a detectable PSA at baseline and no bone metastasis evidenced by bone scan. Initially toremifene 80 milligrams treatment did not affect the underlying prostate cancer. More specifically, this analysis showed by the end of the study 4.1% of men treated with toremifene 80 milligram had new bone met compared to 4.8% of men on placebo.
We believe these are important safety data for toremifene. The data from the ADT trial showed that toremifene 80 milligram treatment can prevent fractures and treat other estrogen deficiency side effects of ADT without negatively affecting the underlying prostate cancer. In fact, the PSA progression safety data suggests that toremifene may be suppressing prostate cancer progression and are consistent with the mechanism of action of toremifene.
In other pre-clinical and clinical studies, including a 514 patient Phase IIB clinical trial for the prevention of prostate cancer in men with high grade PIN, toremifene was shown to have prevented prostate cancer compared to placebo. These observations of the anti- prostatic effect of toremifene in men formed the basis of the ongoing Phase III clinical trial evaluating toremifene 20 milligrams for the prevention of prostate cancer in men with high grade PIN.
To update you on the progress of the PIN trial, in July of this year, an independent Data Safety Monitoring Board conducted a planned semi annual review of the unblinded safety data from the approximately 1,590 patients participating in the Phase III high grade PIN clinical trial and recommended the trial continue as planned. The DSMB to date has now reviewed safety data from the almost 3,000 patients enrolled in both the toremifene 80 milligram Phase III ADT clinical trial and the toremifene 20 milligram Phase III high grade PIN clinical trial with some of these patients taking drug for as long as three years.