SOURCE: Adgero Biopharmaceuticals Holdings, Inc.

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April 10, 2017 09:15 ET

Positive Clinical Data of Adgero Biopharmaceuticals' REM-001 Therapy for the Treatment of Cutaneous Metastatic Breast Cancer Presented at 37th ASLMS Annual Conference

PRINCETON, NJ--(Marketwired - April 10, 2017) - 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.

About Adgero

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.

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