LRP-Directed Peptide-Drug Conjugate Program
Geron's LRP-directed peptide-drug conjugate program is based on molecules that deliver anti-cancer drugs to tumors in the brain, including metastases. In the conjugates, the anti-cancer drugs are linked to a peptide designed to be actively transported across the blood-brain barrier via lipoprotein receptor-related protein (LRP) pathways, predominantly LRP1. LRP1 is also upregulated in many tumors. GRN1005, the Company's lead drug candidate in this program, has three paclitaxel molecules linked to a proprietary 19 amino acid peptide, Angiopep-2. GRN1005 is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. An estimated 200,000 patients in the United States are diagnosed each year with cancers that have metastasized to the brain. There are currently no approved drug therapies for treating brain metastases. Both studies are expected to start by the end of the 2011, with top-line data from these trials expected to be available before the end of the second quarter of 2013.
Oncology Discovery Program
Geron has an active discovery research program that uses proprietary chemistry to address important molecular targets in cancer. The goal of this program is to generate new IND candidates for Geron’s clinical oncology pipeline.
About Geron’s Cell Therapy Programs
Geron’s human embryonic stem cell programs, for which the Company is seeking partnerships, include oligodendrocyte progenitor cells (GRNOPC1) for central nervous system disorders, cardiomyocytes (GRNCM1) for heart disease, pancreatic islet cells (GRNIC1) for diabetes, dendritic cells (GRNVAC2) as an immunotherapy vehicle and chondrocytes (GRNCHND1) for cartilage repair.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding Geron’s plans or expectations for or of: dates to begin or obtain top-line data from any of the Phase 2 oncology clinical trials; having sufficient cash to fund the Company for 20 months to reach milestone and value inflection points without the necessity of raising additional capital; expecting to end 2011 with $150 million in cash and investments; incurring one-time cash expenditures of approximately $5 million and $3 million in 2011 and 2012, respectively; Geron’s ability to partner its stem cell business; clinical development; and future operating results and expenditures, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation: (a) regarding dates for Phase 2 clinical trial initiation or the availability of top-line data — delays in enrollment, delays caused by institutional review boards or regulatory agencies, shortage of supply, dependence on clinical trial collaborators, or safety issues; (b) regarding financial expectations — if any of (a) above, unanticipated expenses or charges may occur as a result of the resizing, or litigation were to occur, or if the Company determined it was in its best interest to raise additional capital; (c) regarding Geron’s ability to partner its stem cell business — third parties’ reluctance to partner, Geron’s intellectual property licensors’ refusal to transfer intellectual property rights from Geron to a third party; and (d) those risks and uncertainties inherent in the development of potential therapeutic products, including without limitation, the protection of Geron’s intellectual property rights. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including the Annual Report on Form 10-K for the year ended December 31, 2010 and quarterly report on Form 10-Q for the quarter ended September 30, 2011. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.