RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Verastem Oncology Inc. (Nasdaq: VSTM), (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced that its partner CSPC Pharmaceutical Group Limited (HKEx: 1093) (CSPC), a leading pharmaceutical company in China, has dosed the first patient in a pivotal Chinese bridging study evaluating COPIKTRA® (duvelisib) in patients with relapsed or refractory follicular lymphoma (FL). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma in the United States.
“Building on CSPC’s strong track record of successfully developing and commercializing oncology products in China, we are pleased that this CSPC trial is now underway as they work to provide a new option for patients with follicular lymphoma in China, where there are limited options for this difficult to treat disease,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “The first patient dosed in this trial is a critical step in our mission to bring COPIKTRA to patients around the world.”
In September of 2018, Verastem Oncology and CSPC entered into an exclusive licensing agreement for CSPC to develop and commercialize Verastem Oncology’s COPIKTRA for the treatment of all oncology indications in China. CSPC’s single-arm, open-label, multi-center pivotal study is designed to evaluate the antitumor activity and safety of duvelisib administered to patients diagnosed with relapsed or refractory follicular lymphoma. This study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 2 DYNAMO study. The results of this study will form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory FL in China.
COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Continued approval in FL may be contingent upon verification and description of clinical benefit in confirmatory trials.
About COPIKTRA (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells, in the United States. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
SELECT IMPORTANT SAFETY INFORMATION
This does not include all information needed to use COPIKTRA (duvelisib) safety and effectively. See full Prescribing Information.
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full Prescribing Information for complete boxed warning
INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
About CSPC Pharmaceutical Group Limited
CSPC Pharmaceutical Group Limited is a leading pharmaceutical group in China. The Company has been listed on the Main Board of the Hong Kong Stock Exchange since 1994 and is currently a constituent stock of Hang Sang Index. CSPC is a leading developer and manufacturer of innovative and generic drugs in China. Blockbuster innovative products in CSPC’s pipeline include NBP (butylphthalide), OULAINING (oxiracetam), XUANNING (maleate levamlodipine), DUOMEISU, JINYOULI and KEAILI. CSPC is also a major manufacturer of bulk drugs, including vitamin C, antibiotics and caffeine. The production facilities of CSPC are mainly located in Shijiazhuang City, Hebei Province, China. For more information, please visit its website at http://www.cspc.com.hk.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. We are driven by the strength, tenacity and courage of those battling cancer – single-minded in our resolve to deliver new therapies that not only keep cancer at bay but improve the lives of patients diagnosed with cancer. Because for us, it’s personal.
Our first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL). Our pipeline comprises product candidates that seek to treat cancer by modulating the local tumor microenvironment. For more information, please visit www.verastem.com.
Source: Biospace
