MINNEAPOLIS - Celcuity Inc. (NASDAQ:CELC), a biotech firm focused on developing cancer treatments, has initiated a clinical trial for a drug combination aimed at treating metastatic castration-resistant prostate cancer (mCRPC). The Phase 1b/2 study, named CELC-G-201, began dosing its first patient today with gedatolisib in combination with darolutamide, an androgen receptor inhibitor.
The trial is designed to evaluate the safety, tolerability, and efficacy of gedatolisib, Celcuity's lead drug candidate, which targets all Class 1 PI3K isoforms and mTORC1/2. This study will include up to 54 participants who have mCRPC and have previously been treated with an androgen receptor inhibitor. The Phase 1b segment will randomly assign 36 participants to receive 600 mg darolutamide with either 120 mg or 180 mg gedatolisib. Following this, the Phase 2 segment will enroll an additional 12 participants to assess the radiographic progression-free survival at six months.
Dr. Igor Gorbatchevsky, Celcuity's Chief Medical Officer, expressed the company's commitment to addressing the unmet medical needs of mCRPC patients, particularly those who have developed resistance to current treatment options. Dr. Karim Fizazi, a primary investigator in the study, also highlighted the scientific rationale behind combining a PAM inhibitor like gedatolisib with an androgen receptor inhibitor in mCRPC research.
In August 2023, Celcuity entered into a clinical trial collaboration and supply agreement with Bayer AG (ETR:BAYGN), which provides darolutamide at no cost for the trial. The company is also running a Phase 3 trial, VIKTORIA-1, testing gedatolisib in advanced breast cancer.
Celcuity's therapeutic development is complemented by its CELsignia diagnostic platform, which analyzes live tumor cells to identify patients likely to respond to existing targeted therapies.
This news is based on a press release statement and contains forward-looking statements regarding the potential of gedatolisib and the expected progress of clinical trials. These statements are subject to risks and uncertainties, and actual results may differ from those projected. Celcuity does not undertake any obligation to update these statements following the publication of this press release.
InvestingPro Insights
As Celcuity Inc. (NASDAQ:CELC) embarks on its latest clinical trial for treating metastatic castration-resistant prostate cancer, investors are closely monitoring the company's financial health and stock performance. With a market capitalization of $378.56 million, the biotech firm is navigating a challenging financial landscape, as evidenced by its negative P/E ratio of -5.46, reflecting investor concerns over profitability.
Recent market activity has seen Celcuity's stock experiencing significant volatility. An InvestingPro Tip highlights that the stock has taken a considerable hit over the last week, with a price total return of -9.58%. This could be indicative of market reactions to the risks associated with drug development and clinical trials. Nonetheless, the company does hold more cash than debt on its balance sheet, which provides some financial stability as it advances its research and development efforts.
Another InvestingPro Tip reveals that Celcuity's net income is expected to drop this year, and analysts do not anticipate the company will be profitable this year. This aligns with the negative earnings per share (EPS) figures reported for the last twelve months as of Q3 2023, standing at -2.75 USD for both basic and diluted EPS. Investors considering Celcuity should also note that the company does not pay a dividend, potentially affecting those seeking income-generating investments.
For those interested in gaining deeper insights into Celcuity's financials and stock performance, additional InvestingPro Tips are available at https://www.investing.com/pro/CELC. There are 9 more tips to discover, which can be accessed with an exclusive offer: use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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