40-site U.S. trial enrolling more than 300
patients could significantly change the way DCIS is treated and
reduce possibly unnecessary surgery
SAN
FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap
Healthcare Collaborative (QLHC) announces the enrollment launch for
the Re-Evaluating Conditions for Active Surveillance Suitability as
Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2
platform study aimed at preventing the progression of DCIS to
breast cancer. The study is evaluating three investigational
endocrine therapy arms: (Z)-endoxifen, a selective estrogen
receptor modulator (SERM) in development by Atossa Therapeutics
(Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of
testosterone (T) and anastrozole (Ai) that targets the androgen and
estrogen receptor pathways in development by Havah Therapeutics;
and ORSERDU® (elacestrant), the only FDA approved oral selective
estrogen receptor degrader (oSERD) in development by Stemline
Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the
Menarini Group.
"DCIS indicates the very earliest, noninvasive stage of the
disease, that's why it is important for us to seek out alternative
therapies for DCIS patients and find ways to reduce toxicity and
unnecessary surgeries. We are excited to partner with three
innovative companies to explore new treatments for this large and
often over-treated patient population," said Laura Esserman, MD, a lead investigator for the
study and founder of QLHC.
Surgery is the current standard treatment for DCIS even though
many patients never progress to breast cancer, which means that
patients are often over-treated with invasive procedures. This
new trial, sponsored and operated by QLHC, offers DCIS patients up
to six months of endocrine therapy with the intent to forego
surgery and instead be monitored via long-term active surveillance,
if appropriate. A key element in reducing overtreatment of
DCIS is identifying biomarkers that reflect the risk of progression
so that those with low-risk lesions are spared surgery. RECAST DCIS
features the assessment of imaging and molecular-based biomarkers
in addition to evaluating new investigational agents in this
setting. The study is open to enrollment with each investigational
agent arm expected to enroll up to 110 patients.
The three collaborators for this trial, Atossa Therapeutics,
Havah Therapeutics, and Stemline, all aim to find alternative
solutions for DCIS patients and are providing different agents for
assessment.
Atossa's (Z)-endoxifen has the potential to mitigate
breast cancer risk (by reducing the density of breast tissue); to
reduce cancer cell activity before surgery; and to reduce the risk
of recurrent or new breast cancer after the initial treatment.
According to published studies, (Z)-endoxifen is a competitive
inhibitor of ERα and represses ERα transcriptional activity
(Z)-endoxifen is 100-fold more potent in anti-estrogen activity
compared to other SERMs. (Z)-endoxifen also binds to and disrupts
protein kinase C beta one function (PKCb1, a known oncogenic
protein). The National Cancer Institute (NCI) and others have
studied (Z)-endoxifen and have demonstrated promising results in
the treatment of breast cancer as well as for the treatment of
other solid tumors. Treatment with (Z)-endoxifen may avoid off
target effects of tamoxifen and remaining metabolites potentially
increasing adherence by improving the safety profile.
Havah Therapeutics' HAVAH T+Ai™ combines T, the natural
ligand for the androgen receptior and Ai, an inhibitor of T
conversion to estradiol, to modulate the growth of abnormal breast
tissues. HAVAH T+Ai™ is a proprietary combination subcutaneously
delivered system to overcome hormonal symptoms by balancing
hormonal irregularities in the breast, developed from more than 10
years of clinical research into hormonal regulation in women. Havah
has extensive clinical experience using HAVAH T+Ai™ to address pre-
and postmenopausal prevention of breast disease, and the company
generated data from more than 1,000 Australian women with breast
disease through an ongoing open label cohort study (more than 6,200
implants), with critical safety pharmacokinetic and early efficacy
data already demonstrated.
Stemline's Elacestrant (ORSERDU), was approved by the
U.S. Food & Drug Administration in January 2023 for the treatment of postmenopausal
women or adult men with estrogen receptor (ER)-positive,
HER2-negative, ESR-1 mutated advanced or metastatic breast cancer,
following at least one line of endocrine therapy. For more
information including full prescribing information and important
safety information, please visit https://www.orserdu.com/.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501c(3) charitable
organization established in 2005 as a collaboration between medical
researchers at University of California, San
Francisco and Silicon Valley entrepreneurs. Our mission is
to integrate high-impact research with clinical processes and
systems technology, resulting in improved data management and
information systems, greater access to clinical trial matching and
sponsorship, and greater benefit to providers, patients and
researchers. Our goal is to improve and save lives. For more
information, visit https://www.quantumleaphealth.org/.
About Atossa
Atossa Therapeutics is a clinical stage biopharmaceutical
company developing innovative medicines in areas of significant
unmet medical need in oncology. Atossa's current focus is on breast
cancer. More information is available at
atossatherapeutics.com.
About Havah Therapeutics
Havah Therapeutics is a biopharmaceutical company developing
innovative, proprietary hormonal therapies that aim to improve
quality of life for women. Havah brings together a world-class team
passionate about helping women live lives free from the suffering
caused by breast pain, debilitating menopausal symptoms and breast
cancer. More information is available at www.havahtx.com.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and
diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini
is focused on therapeutic areas with high unmet needs with products
for cardiology, oncology, pneumology, gastroenterology, infectious
diseases, diabetology, inflammation, and analgesia. With 18
production sites and 9 Research and Development centers, Menarini's
products are available in 140 countries worldwide. For further
information, please visit www.menarini.com.
About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. ("Stemline") a wholly-owned
subsidiary of the Menarini Group, is a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics. Stemline
commercializes ORSERDU® (elacestrant) in the United States, an oral endocrine therapy
indicated for the treatment of postmenopausal women or adult men
with estrogen receptor (ER)-positive, human epidermal growth factor
receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic
breast cancer with disease progression following at least one line
of endocrine therapy. Stemline also commercializes ELZONRIS®
(tagraxofusp-erzs), a novel targeted treatment directed to CD123
for patients with blastic plasmacytoid dendritic cell neoplasm
(BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment
for BPDCN in the US and EU to date. Stemline also commercializes
NEXPOVIO® in Europe, an XPO1
inhibitor for multiple myeloma. Stemline also has an extensive
clinical pipeline of small molecules and biologics in various
stages of development for a host of solid and hematologic
cancers.
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SOURCE Quantum Leap Healthcare Collaborative