CG Oncology Initiates Expanded Access Program for Cretostimogene Grenadenorepvec
CG Oncology has launched an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The first patient has been dosed, and enrollment is ongoing. This move aims to provide more treatment options for NMIBC patients, reflecting CG Oncology's commitment to addressing this recurrent cancer. Key figures in the bladder cancer community, such as Andrea Maddox-Smith from the Bladder Cancer Advocacy Network, emphasize the hope that EAPs represent for patients who have exhausted all approved treatments.
- Initiation of an Expanded Access Program (EAP) for NMIBC patients unresponsive to BCG.
- First patient dosed in the EAP, indicating progress in the program.
- Ongoing enrollment in the EAP suggests potential for increased patient access.
- Reflects CG Oncology's commitment to patient care and expanding therapeutic options.
- Support from the Bladder Cancer Advocacy Network highlights the program's significance for patients.
- Potential risks and uncertainties associated with the investigational nature of cretostimogene grenadenorepvec.
- Financial implications of expanding the program without guaranteed positive outcomes.
- Possible delays or issues in patient enrollment affecting the program’s progress.
Insights
The initiation of an Expanded Access Program (EAP) for cretostimogene grenadenorepvec highlights CG Oncology's dedication to addressing the unmet needs in bladder cancer therapy. EAPs allow patients who have exhausted all other treatment options to gain access to investigational drugs. This move could potentially offer significant relief to patients with Non-Muscle Invasive Bladder Cancer (NMIBC) who do not respond to Bacillus Calmette-Guerin (BCG).
From a scientific standpoint, the use of oncolytic immunotherapy, which uses viruses to target and kill cancer cells while stimulating an immune response, represents a promising frontier in cancer treatment. The dosing of the first patient indicates the program's swift progression. However, it's important to note that while EAPs provide hope, they also involve drugs that are still in the experimental phase, meaning their safety and efficacy are not yet fully established. This can present risks for patients but is often a calculated one given the lack of alternatives.
For investors, the success of this EAP could signal the potential for cretostimogene grenadenorepvec to receive broader approval, depending on the outcomes observed.
The announcement of the Expanded Access Program (EAP) for CG Oncology’s cretostimogene grenadenorepvec is a noteworthy development from a financial perspective. EAPs can significantly de-risk the clinical trial process by generating real-world data from patients who are not eligible for traditional trials. This data can be instrumental in gaining regulatory approvals and accelerating the commercialization process.
For CG Oncology, the successful implementation of this EAP could enhance investor confidence and attract more funding. The positive outlook stems from the high recurrence rate of bladder cancer and the limited treatment options available, which positions cretostimogene as a potentially high-demand therapeutic if proven effective. Additionally, the company's focus on NMIBC, a condition with significant market potential, aligns well with its strategic objectives.
However, investors should be cautious about the inherent risks involved in the development of experimental therapies, as unforeseen adverse effects or insufficient therapeutic benefits could impact the stock adversely.
The launch of CG Oncology’s EAP for cretostimogene grenadenorepvec is strategically timed, as the market for bladder cancer treatments continues to grow. The unmet medical need in Non-Muscle Invasive Bladder Cancer (NMIBC) offers a lucrative opportunity for innovative therapeutics. By initiating the EAP, CG Oncology is not only providing access to potentially life-saving treatment but also positioning itself as a key player in the oncolytic virus therapy market, which is expanding at a rapid pace.
The feedback and data collected from patients in this program will be critical in understanding the drug's market potential. If positive outcomes are reported, it could lead to an accelerated approval process, thereby enabling CG Oncology to capture market share more swiftly. This type of proactive patient engagement and real-world evidence collection is increasingly favored by regulatory bodies and could improve the likelihood of future approvals.
For retail investors, the initiation of this program could be seen as a step towards de-risking the investment in CG Oncology, albeit with the acknowledgment of the typical risks associated with pharmaceutical development and market entry.
- First Patient Dosed in Expanded Access Program and Enrollment Ongoing -
IRVINE, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that it has initiated an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guerin (BCG) and meet certain program eligibility criteria. The first patient has been dosed in the EAP and enrollment in the study is ongoing.
“Bladder cancer is a highly recurrent disease with few treatment options available to patients,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “This program reflects our commitment to patients afflicted with NMIBC and our desire to ensure that they have efficient access to cretostimogene, our novel oncolytic immunotherapy candidate.”
"Navigating NMIBC can be a journey filled with uncertainties, especially given how frequently bladder cancer recurs," said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network (BCAN). "At BCAN, patients are at the forefront of everything we do. Despite the progress being made to find new treatments, there are times when patients have exhausted all approved treatment options, and they are not eligible for a traditional clinical trial. Expanded Access Programs represent tremendous hope for these patients and their families, by allowing them access to investigational drugs that they would not otherwise have available to them."
About Expanded Access to Cretostimogene Grenadenorepvec
EAP programs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition, to gain access to an investigational medical treatment outside of clinical trials before it is approved by the U.S. Food and Drug Administration (FDA), when no comparable or satisfactory alternative therapy options are available. Healthcare providers and bladder cancer patients who are interested to learn more about CG Oncology’s EAP including eligibility criteria may visit www.clinicaltrials.gov, NCT06443944, or contact EAP@cgoncology.com.
To learn more about CG Oncology’s clinical studies please visit the CG Oncology website at www.cgoncology.com.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients and access to cretostimogene through the Company’s Expanded Access Program (EAP) for certain patients with NMIBC; the anticipated timing of BOND-003 final data; and the Company’s expectations on a regulatory approval submission. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: additional patient data related to cretostimogene in combination with pembrolizumab that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; potential delays in the commencement, enrollment and completion of clinical trials; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
(508) 654-2277
sarah.connors@cgoncology.com
Investor Relations
Laurence Watts
New Street IR
(619) 916-7620
IR@cgoncology.com
FAQ
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