- Reached Maximum Tolerated Dose in Twice Weekly Dosing Schedule with EC1456 -
- Initiating EC1456 Expansion Cohort in Targeted Population of Folate Receptor-Positive Non-Small Cell Lung Cancer Patients -
- Data Presentations Expected for EC1456 and EC1169 in the Second Half of 2016 -
- Conference Call Today at 4:30 p.m. EDT -
"Excitement is building around our lead assets, EC1456 and EC1169, as data to date has demonstrated attractive safety profiles and signs of anti-tumor activity for both agents. Later this month, we will advance EC1456 into targeted patients with non-small cell lung cancer (NSCLC) expressing the folate receptor, who are most likely to respond," said
The EC1456 phase 1 dose escalation data presented at the
The EC1169 phase 1 dose escalation study, as presented at ASCO, highlighted that all patients in the study have some level of prostate specific membrane antigen (PSMA) positivity, and the drug has been well tolerated.
"EC1169 has the potential to be a truly differentiated therapy, and it has shown signs of anti-tumor activity, even at low doses, including reductions of prostate-specific antigen levels greater than 50 percent in some patients," commented
Upcoming Expected Milestones
Second Quarter 2016 Financial Results
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents and investments were
The company revised guidance for its expected cash balance at the end of 2016 to be above
About the EC1456 Phase 1 Trial
This open-label, multicenter, non-randomized, dose-escalation study is divided into two parts. The first part of the study was designed to evaluate safety and tolerability and identify the MTD of EC1456 in patients with metastatic or locally advanced solid tumors.
The second part of the study will determine the efficacy of EC1456 in patients with FR-positive NSCLC treated with the MTD. The BIW dosing schedule at 6.0 mg/m2 will be evaluated first. Upon the completion of this dosing schedule, additional patients will be enrolled in a once per week dosing schedule cohort. Single agent tumor response will be evaluated, which will inform and may trigger additional work in combination therapies and indications such as triple-negative breast cancer, ovarian cancer and endometrial cancer. Patient FR-status will be determined using the investigational companion imaging agent, EC20 (etarfolatide). EC1456 is currently being evaluated in a phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).
About the EC1169 Phase 1 Trial
This open-label, multicenter, non-randomized, dose-escalation study is divided into two parts. The first part of the study was designed to evaluate safety and tolerability and identify the MTD of EC1169 in patients with prostate cancer.
The second part of the study will determine the efficacy of the MTD of EC1169 in mCRPC patients who have been previously treated with a taxane-based chemotherapy. The primary study endpoint will be radiological progression free survival in patients selected as PSMA-positive. A second cohort will include an exploratory assessment of taxane-naïve patients. Patient PSMA status will be determined using the investigational companion imaging agent, EC0652. EC1169 is currently being evaluated in a phase 1 study in mCRPC patients (ClinicalTrials.gov Identifier: NCT02202447).
A live, listen-only webcast of the conference call may also be accessed by visiting the Investors & News section of the
The webcast will be recorded and available on the company's website for 90 days following the call.
Forward Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to future spending, future cash balances, the successful completion of current and future clinical trials, the enrollment period for and availability of data from ongoing and future clinical trials, and the company's future development plans including those relating to the completion of preclinical development in preparation for possible future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company's product candidates; risks that early stage preclinical data may not be indicative of subsequent data when expanded to additional preclinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company's ability to capture value for the technology; estimates of the potential markets for its product candidates; estimates of the capacity of manufacturing and other facilities required to support its product candidates; projected cash needs; and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by
Statements of Operations
(dollars in thousands, except per share amounts)
|For the Three Months|
|For the Six Months|
|Costs and expenses:|
|Research and development||6,724||6,788||13,341||13,319|
|General and administrative||4,071||7,394||8,431||11,214|
|Total costs and expenses||10,795||14,182||21,772||24,533|
|Loss from operations||(10,782||)||(14,169||)||(21,747||)||(24,508||)|
|Interest income, net||185||208||337||397|
|Other expense, net||(7||)||(1||)||(64||)||(4||)|
|Net loss per share - basic and diluted||$||(0.25||)||$||(0.33||)||$||(0.51||)||$||(0.57||)|
|Weighted average number of common shares used in net loss per share - basic and diluted||41,939,052||42,178,537||41,898,702||42,144,182|
|As of||As of|
|Cash, cash equivalents and investments||$||173,600||$||154,609|
|Liabilities and stockholders' equity|
|Deferred revenue and other liabilities, net of current portion||851||818|
|Total stockholders' equity||171,346||154,045|
|Total liabilities and stockholders' equity||$||178,386||$||159,407|
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, firstname.lastname@example.org
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