|Over a week ago|
Galectin Therapeutics to host conference call » 15:5509/2909/29/20
Management discusses the…
Galectin Therapeutics to host conference call » 04:5509/2909/29/20
Management discusses the…
|Over a month ago|
Galectin Therapeutics to host conference call » 17:5909/2409/24/20
Management discusses the…
Galectin Therapeutics appoints Joel Lewis as CEO » 08:0209/0209/02/20
Galectin announced the…
Galectin announced the appointment of current board member, Joel Lewis, to the position of CEO and President. In this position, Mr. Lewis will set corporate strategy and oversee operations, most importantly the Company's global NASH-RX adaptively-designed trial for the prevention of varices in NASH cirrhosis patients using its proprietary galectin-3 inhibiting compound, belapecti. Dr. Harold Shlevin, who is retiring from the CEO position, has signed a consulting agreement through which he has agreed to devote significant effort to advancing the NASH-RX trial. Dr. Shlevin and Mr. Lewis will retain their positions on Galectin's Board of Directors. Prior to joining Galectin Therapeutics, Mr. Lewis served for 13 years as the Managing Director of Shareholder Services at Uline.
Galectin expects to require more cash to fund operations after Sept. 2021 » 09:3108/1008/10/20
The Company expects that…
The Company expects that it will require more cash to fund operations after September 30, 2021 and believes it will be able to obtain additional financing as needed. The total cost to obtain the interim analysis data of the planned trial, including general overhead, is currently estimated to be approximately $90 million. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond September 30, 2021, or, if available, that any such financing will be on terms acceptable to us.
Galectin Therapeutics expects cash to fund operations through at least Sept. 30 » 09:3008/1008/10/20
As of June 30, 2020, the…
As of June 30, 2020, the Company had $40.8 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2021.
Galectin Therapeutics reports Q2 EPS (11c), two est. (9c) » 09:3008/1008/10/20
Harold H. Shlevin, Ph.D.,…
Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "We are excited to have initiated the NASH-RX trial, having enrolled our first patient in June and continuing to enroll patients at several of our sites in our clinical trial of belapectin targeting cirrhotic NASH patients. If the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunity with a pharmaceutical company. Later this quarter, we plan to host a conference call with the Investment Community for a more thorough discussion of the NASH-RX trial, its current status, our updated strategy, and to take questions."
|Over a quarter ago|
Galectin commences patient enrollment in Phase 2b/3 trial of belapectin » 08:0606/3006/30/20
Galectin Therapeutics announced that it has enrolled its first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of its galectin-3 inhibitor belapectin, the company's lead compound, in nonalcoholic steatohepatitis cirrhosis patients who have clinical signs of portal hypertension and are at risk of developing esophageal varices. Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial. NASH-RX is expected to enroll approximately 315 NASH patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia. During the Phase 2b part of the trial, two belapectin doses, 2 mg/kg of lean body mass and 4 mg/kg LBM, will be compared to placebo. Prior trials have demonstrated the good tolerance profile and apparent safety of belapectin with doses of up to 8 mg/kg LBM, notably for up to 52 weeks of treatment in patients with NASH cirrhosis. The study design provides for a prespecified interim analysis of efficacy and safety data conducted after all planned subjects in the Phase 2b component have completed at least 78 weeks of treatment and a gastro-esophageal endoscopic assessment. This adaptive design allows for patients to seamlessly transition from the Phase 2b component into the Phase 3 stage, as well as helps determine the optimal dose, bolsters the efficacy signal, and re-evaluates the sample size and statistical power for the Phase 3 stage of the trial. These adaptations are designed to increase the statistical power for detecting a successful outcome. The IA also provides for adjustment in the randomization ratio, refinement of inclusion/exclusion criteria and the potential termination of the study for overwhelming efficacy or for futility. Unlike most other clinical trials focused primarily on earlier stages of NASH, the NASH-RX study population will comprise patients with compensated liver cirrhosis. Based on the results of the NASH-CX trial, NASH-RX is focused on patients who have not yet developed esophageal varices but are at increased risk of developing these potentially life-threatening complications. Consequently, patient selection for both Phase 2b and Phase 3 will be based on clinical signs of portal hypertension such as a depressed platelet count, an enlargement of the spleen and/or evidence of collateral vessels. The primary endpoint of the trial is to assess the effect of belapectin on the incidence of new varices. A centralized review system of video recording of esophagogastroduodenoscopy has been put in place, and the primary endpoint will be adjudicated by expert EGD readers. Key secondary endpoints will assess the type of varices and other clinical events, such as ascites, hepatic encephalopathy, listing for liver transplantation or death. NASH-RX was designed in accordance with advice from the U.S. Food and Drug Administration and with key contributions from our NASH-RX co-primary study investigators, Dr. Naga Chalasani and Dr. Stephen Harrison, both widely recognized expert hepatologists for NASH, biostatistical experts and numerous other collaborators at Covance, the CRO for the study. The design of the NASH-RX trial optimizes patient enrollment and retention and minimizes the need for invasive tests.
Galectin Therapeutics expects cash to fund operations through at least Sept. 30 » 08:5005/1105/11/20
As of March 31, 2020, the…
As of March 31, 2020, the Company had $43.3 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2021. The Company expects that it will require more cash to fund operations after September 30, 2021, and believes it will be able to obtain additional financing as needed. The total cost to obtain the interim analysis data of the planned trial, including general overhead, is currently estimated to be approximately $125 million; however, the costs and timing of such trial are not yet completely finalized. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond September 30, 2021, or, if available, that any such financing will be on terms acceptable to us.
Galectin Therapeutics expects first initiation in NASH-RX trial in 2Q20 » 08:5005/1105/11/20
The NASH-RX trial will…
The NASH-RX trial will use an adaptive design, confirm dose selection, and reaffirm the efficacy data observed in the NASH-CX trial and, with pre-planned adaptations, inform the larger Phase 3 trial component. The protocol for a seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, was submitted to the U.S. Food and Drug Administration on April 30, 2020. The filing currently anticipates clinical trials will begin in the second quarter of this year. The design of this trial reflects the unmet medical needs of the target patient population for belapectin treatment: NASH patients with compensated cirrhosis who develop esophageal varices. Bleeding varices are a cause of death in about one-third of cirrhotic patients. Currently, there is no approved treatment for preventing varices in these patients. The development of new varices reflects the progression of hepatic cirrhosis and thus portends the development of other cirrhosis complications and outcomes such as significant ascites, hepatic encephalopathy, and eventual liver failure. In addition on March 31, 2020, the Company also filed with the FDA a protocol for the hepatic impairment study, with the study also currently anticipated to begin in the second quarter of this year. Galectin Therapeutics will share more details about the protocol at the time the clinical trial begins.