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Phase 1 Trial of Oral IPI-493 Enhances Industry-Leading Program Targeting Hsp90 Inhibition. Potential First-in-Class Hsp90 Inhibitor Expected to Enter. Phase 3 Registration Trial This Quarter
CAMBRIDGE, MA, USA | Aug. 4, 2008 | Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative cancer drug discovery and development company, today provided a research and development (R&D) update and announced financial results for the second quarter of 2008.
Recently, Infinity:
* initiated a Phase 1 study of IPI-493, its oral anti-chaperone therapy that inhibits heat shock protein 90 (Hsp90), in patients with advanced solid tumors;
* presented positive clinical data on the activity and safety of IPI-504 (retaspimycin hydrochloride), Infinity's lead anti-chaperone agent, in a Phase 1 study in patients with refractory gastrointestinal stromal tumors (GIST);
* continued to advance IPI-504 toward initiation of an international registration trial in patients with refractory GIST, with enrollment expected to open in the third quarter of 2008; and
* ended the second quarter of 2008 with $94.5 million in cash, cash equivalents, and available-for-sale securities, providing funds to support the company's current operating plan into 2010.
"At Infinity, we continued to make significant advances in our pipeline this past quarter, particularly with the recent developments in our anti-chaperone program," said Steven H. Holtzman, president, chair, and chief executive officer. "We remain in a strong financial position, we are delivering on the research and development objectives we laid out at the beginning of the year, and we are on track to achieve important catalysts, including the planned launch of a pivotal trial of IPI-504 later this year."
Anti-Chaperone Program Update
Infinity recently initiated a Phase 1 clinical trial evaluating IPI-493, its orally delivered anti-chaperone agent that inhibits Hsp90, in patients with advanced solid tumors. The multi-center, dose-escalation study is designed to assess safety and tolerability and identify a dose and schedule for subsequent studies of IPI-493. Anti-tumor activity will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) and disease-specific markers. In preclinical models, IPI-493 has demonstrated significant oral availability, as well as potent and selective inhibition of Hsp90.
"We are delighted to have expanded our clinical program by entering into a Phase 1 clinical trial with IPI-493, our proprietary oral anti-chaperone therapy," added Julian Adams, Ph.D., president of research and development and chief scientific officer. "This marked an important event for Infinity, and we are pleased to have our second product candidate in the clinic. We are confident in the broad potential of our anti-chaperone portfolio and in our team's ability to continue advancing those programs in order to bring important new medicines to patients."
Positive results of Infinity's lead anti-chaperone agent, IPI-504, in a Phase 1 study in patients with metastatic and/or unresectable GIST were presented during the Annual Meeting of the American Society for Clinical Oncology in June 2008. Results from the study showed that patients with GIST (n=36), who were heavily pre-treated, experienced a 70 percent overall disease control rate, with three percent Partial Response and 67 percent Stable Disease at six weeks. Estimated median progression free survival for these patients was 12 weeks. Based on these results, Infinity plans to initiate an international Phase 3 registration trial of IPI-504 in patients with refractory GIST, for which enrollment is expected to open in the third quarter of 2008. The Phase 3 protocol has been granted a Special Protocol Assessment agreement by the U.S. Food and Drug Administration (FDA), and the European Medicines Evaluation Agency has provided scientific advice consistent with that of the FDA regarding the Phase 3 trial design.
IPI-504 is also being evaluated in the Phase 2 portion of a Phase 1/2 study in patients with advanced non-small cell lung cancer (NSCLC). In 2007, Infinity reported preliminary evidence of biological activity from the Phase 1 portion of the trial. Infinity anticipates reporting preliminary results from the Phase 2 portion of the NSCLC trial by the end of 2008.
Infinity also has an ongoing Phase 1b clinical trial evaluating IPI-504 in combination with docetaxel in patients with advanced solid tumors. In July, Infinity decided to discontinue further enrollment in its Phase 2 single agent, signal-finding study of IPI-504 in advanced hormone-refractory prostate cancer. Based on the lack of observed evidence of biological activity in the trial, Infinity concluded that the overall risk-benefit ratio did not justify continuing the signal-finding study as a single agent in this indication. Additional clinical trials of IPI-504 are expected to commence by early 2009.
IPI-504 and IPI-493 are being jointly developed with AstraZeneca/MedImmune.
Hedgehog Pathway Inhibitor Program Update
Infinity anticipates commencing a Phase 1 safety study of IPI-926, its lead Hedgehog pathway inhibitor, in the second half of 2008 in patients with solid tumors. IPI-926 has demonstrated significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma and tumor half-life, and dose-dependent inhibition of tumor growth, in a number of preclinical models.
Second Quarter Financial Results
At June 30, 2008, Infinity had total cash, cash equivalents, and available-for-sale securities of $94.5 million.
Total revenue for the second quarter of 2008 was $2.5 million as compared to $5.7 million for the second quarter of 2007. The decrease in revenue was due to the recognition of revenue in the second quarter of 2007 from the company's Bcl-2 collaboration and its small molecule technology access alliance with Novartis. Infinity successfully completed all of its technology access alliance obligations to Novartis as of December 31, 2007. Infinity transitioned the Bcl-2 program to Novartis in February 2008; therefore, Infinity did not recognize any revenue from the up-front license fee or for reimbursable research and development services in the three months ended June 30, 2008, nor does the company expect to recognize such revenue in future periods.
R&D expense was $10.8 million for the second quarter of 2008 as compared to $8.2 million for the second quarter of 2007. R&D costs that are reimbursable by AstraZeneca/MedImmune under the cost-sharing provisions of the companies' collaboration agreement are offset against Infinity's R&D expense. Therefore, Infinity's R&D expense of $10.8 million for the second quarter of 2008 reflects total R&D expenditures by Infinity of $15.3 million less $4.5 million in AstraZeneca/MedImmune reimbursable amounts. Infinity's R&D expense of $8.2 million for the second quarter of 2007 reflects total R&D expenditures by Infinity of $11.6 million less $3.4 million in AstraZeneca/MedImmune reimbursable amounts. The increase in R&D expense is primarily due to higher clinical and pharmaceutical development expenses, partially offset by higher AstraZeneca/MedImmune reimbursable amounts.
General and administrative expense was $3.7 million for the second quarter of 2008 as compared to $3.2 million in the second quarter of 2007. The increase in expense primarily reflects an increase in consulting expenses and an increase in stock-based compensation expense.
Infinity's net loss for the second quarter of 2008 was $11.1 million as compared to a net loss of $4.2 million for the second quarter of 2007. Basic and diluted net loss per common share was $0.57 for the second quarter of 2008, compared to a basic and diluted net loss per common share of $0.21 for the second quarter of 2007.
To achieve its 2008 R&D and business objectives, Infinity continues to project a net cash burn of $35 million to $45 million in 2008. In the absence of any additional financings or business development activities, Infinity anticipates it has sufficient resources to fund its current operating plan into 2010.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. For more information on Infinity, please refer to the company's website at http://www.infi.com.
SOURCE: Infinity Pharmaceuticals, Inc. |
