PIPELINE
TARA-002
TARA-002
TARA-002 Systemic Priming
TARA-002 Systemic Priming + maintenance
TARA-002 Combination
IV CHOLINE
TARA-002
*Currently in pre-clinical studies to define dosing and, once protocol is confirmed, expect to initiate P2 trial cohort.
**Granted Orphan Drug Designations by the U.S. FDA for the prevention and/or treatment of choline deficiency in patients on long-term PN and Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.
***TARA-002 granted Rare Pediatric Disease designation by the U.S. FDA and orphan drug designation by the European Commission for the treatment of LMs.
†Trial also includes BCG-Exposed patients.
TARA-002 is an investigational cell therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd.
TARA-002 is currently being studied in a Phase 2 open-label clinical trial in NMIBC patients with high-grade carcinoma in situ who are BCG-unresponsive and BCG-naive.
TARA-002 is also being studied in a Phase 2 open-label clinical trial for the treatment of macrocystic and mixed cystic LMs in pediatric patients.
IV Choline Chloride is an investigational, intravenous (IV) phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS).
Protara is committed to identifying and advancing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs.
Protara advances its investigational therapies, TARA-002 and IV Choline Chloride, by continuing to study them in clinical trials designed to evaluate potential efficacy, safety, and tolerability. Additional information about our ongoing clinical trials can be found on ClinicalTrials.gov.
We maintain that the best way to make our investigational therapies available to patients is by enrolling and completing all of our clinical trials and, if those trials are successful, pursuing regulatory approval. However, in circumstances where patients are not eligible for our clinical trials and may not have options for alternative therapies, Protara evaluates requests to make its medicines available via expanded access for eligible patients. Expanded access, also called compassionate use, makes an investigational product available for treatment outside of clinical trials when no comparable or satisfactory alternative therapy option is available.
Expanded access will only be considered when certain conditions are met. These conditions include the following:
- The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option.
- The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition.
- The patient is not eligible or cannot participate in a clinical trial.
- A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available.
- Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access.
- Adequate supply of the investigational drug is available.
- Expanded access must be permitted by, and run in accordance with, applicable laws.
- The treating physician making the request is licensed and qualified to administer the investigational medicine and agrees to comply with Protara’s requirements and local regulations governing expanded access and to adhere to applicable laws and regulations.
All questions and requests regarding Protara’s expanded access program should be submitted to the company by email to Patients@Protaratx.com. We regularly monitor this mailbox and aim to acknowledge and respond to each submitted request.
Protara will continually assess our expanded access policy and provide updates to this website as needed.
