PRINCETON, NJ -- (Marketwired) -- 04/10/17 -- Adgero Biopharmaceuticals Holdings, Inc. ("Adgero" or the "Company"), a privately-held biopharmaceutical company leveraging its late stage photodynamic therapy ("PDT") platform for the treatment of serious cutaneous oncology indications, announced today that positive data from the clinical studies of the Company's lead product candidate, REM-001 Therapy, was presented at the 37th ASLMS Annual Conference held April 5-9, 2017 in San Diego, CA.
REM-001 Therapy has been studied in four Phase 2/3 clinical trials in cutaneous metastatic breast cancer ("CMBC") patients, primarily targeting patients who had previously failed radiation therapy. Adgero is also currently evaluating Phase 2a data of REM-001 Therapy for the treatment of recurrent basal cell carcinoma, particularly in patients with basal cell Nevus syndrome ("BCNS").
The Company's clinical data was presented on Saturday, April 8, 2017 in an abstract entitled, "Synergistic Effect of Simultaneous Chemotherapy and Photodynamic Therapy." The data was presented by Steve Rychnovsky, PhD, Vice President of Operations and Product Development.
The data presented was a retrospective analysis done to assess the role of chemotherapy in four IRB/FDA approved Phase 2/3 studies using REM-001 Therapy in 149 patients with CMBC, the majority of which had failed radiation therapy. Patients enrolled could be on hormone therapy, 5-FU or navelbine at baseline, but the studies consisted of both patients with and without hormone/chemotherapy. The analysis for the data presented looked at lesion response, which is defined as a 50% or greater reduction in lesion size. Patients in the studies were followed for 24-52 weeks, with a requirement of 2 follow-up visits after lesions became evaluable. The overall lesion response rate was 88% for patients treated in the group receiving REM-001 Therapy plus chemotherapy/hormone therapy and 81% for patients treated in the group receiving REM-001 Therapy alone. Given that the difference in response rates for the two groups was within experimental error, the Company believes the overall response rate driven by REM-001 Therapy is independent of whether or not the patient received chemotherapy or hormone therapy.
"The results from our analysis indicated that REM-001 provided a high lesion response rate in those patients that were evaluable and, more importantly that the response is believed to be independent of whether or not the patient received chemotherapy. Our conclusion from this data is that REM-001 Therapy may be a complementary treatment to chemotherapy for metastatic breast cancer patients that have CMBC and we believe that REM-001 Therapy holds promise as a locoregional CMBC treatment to prevent widespread lesion development," stated Ron R. Allison, MD, Chief Medical Advisor of Adgero, member of the Scientific Advisory Board and the clinical investigator in the REM-001 Therapy clinical trials in CMBC.
About REM-001 Therapy
The Company's lead product in development, REM-001 Therapy consists of three parts -- a laser light source, a light delivery device and the drug REM-001 (collectively, REM-001 Therapy). REM-001 is a second-generation photosensitizer drug that has undergone late stage clinical development, and which Adgero believes possesses multiple advantages over earlier generation PDT compounds. The lead indication for REM-001 Therapy is unresectable cutaneous metastatic breast cancer ("CMBC"), a disease that may affect individuals with advanced breast cancer and for which effective treatment options are limited.
Adgero Biopharmaceuticals Holdings, Inc. is a privately-held biopharmaceutical company focused on building a pipeline by advancing its proprietary late stage photodynamic therapy ("PDT") platform with broad utility for the treatment of serious cutaneous oncology indications. Its lead product candidate, REM-001 Therapy, has been previously studied in four Phase 2 and/or Phase 3 clinical trials in patients with cutaneous metastatic breast cancer ("CMBC"), who had previously received chemotherapy and failed radiation therapy. Completion of a Phase 3 trial in individuals with CMBC could lead to approval of REM-001 Therapy.
For more information, please visit www.AdgeroBiopharm.com.
This press release contains certain forward-looking statements, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company's control, affect the Company's operations, performance, business strategy and results and there can be no assurances that the Company's actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Source: Adgero Biopharmaceuticals Holdings, Inc.
Released April 10, 2017