SOURCE: LifeSci Advisors

LifeSci Advisors

July 29, 2013 15:01 ET

LifeSci Advisors Initiates Coverage of Stemline Therapeutics

SL-401, Targeting Cancer Stem Cells and Tumor Bulk, Has Orphan Status in Multiple Oncology Indications; Available for Download at www.lifesciadvisors.com/clients/stemline/

NEW YORK, NY--(Marketwired - Jul 29, 2013) - LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Stemline Therapeutics Inc. (NASDAQ: STML), a leading company in the development of oncology products that target both tumor bulk and cancer stem cells (CSCs). Most cancer therapies target only the tumor bulk, leaving CSCs unaffected, leading to a recurrence of the tumor. Stemline's therapies are specifically designed to induce responses and prolong survival. The Company's development candidates SL-401 and SL-701 have elicited complete responses and a survival advantage, and have been well-tolerated.

"Stemline's approach to cancer treatment, targeting the cancer stem cells that support tumor growth and recurrence, is innovative and may provide patients with longer lasting remission from cancer," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The company has a potential accelerated path to market for SL-401 in the orphan indication blastic plasmacytoid dendritic cell neoplasm, with potential to expand into indications such as acute myeloid leukemia, myelodysplastic syndrome, multiple myeloma, and other cancers."

SL-401 is a novel targeted therapy that attacks both tumor bulk cells and CSCs of multiple hematologic cancers including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). SL-401 targets the interleukin-3 receptor (IL-3R), which is over-expressed on tumor cells and CSCs, but is only minimally expressed on healthy cells. As trials conducted to date have shown, this specific activity leads to an improved safety profile with minimal off-target effects. IL-3R is strongly over-expressed on BPDCN, an uncommon but very aggressive cancer that has no good treatment options. In the Phase 1/2 trial of single agent SL-401, 5 of 6 BPDCN patients achieved tumor shrinkage (83% overall response rate), and there were 3 complete responses (CR). In addition to BPDCN, SL-401 has shown very promising single agent activity in patients suffering from relapsed/refractory AML.

The company is also developing SL-701 which is an off-the-shelf, subcutaneously injected peptide vaccine for advanced brain cancer. Highly malignant gliomas have high fatality rates because they grow rapidly, regenerate and have tendrils extended into surrounding brain areas that often cannot be accessed surgically or adequately respond to chemotherapy and/or radiation. SL-701, is comprised of several synthetic peptides, is designed to stimulate the immune system in a very targeted manner to cross the blood-brain barrier and attack tumor cells located anywhere in the brain. In Phase 1/2 clinical trials, SL-701 was shown to be safe and well tolerated, with injection site reactions and fever the only notable adverse events. These trials also showed single agent efficacy, with an overall response and disease stabilization rate of 59% (13/22) in adult patients with recurrent/refractory high-grade gliomas, including recurrent/refractory glioblastoma multiforme (GBM). The overall response and disease stabilization rate in pediatric patients with gliomas, including brainstem and non-brainstem gliomas, was 86% (19/22).

In a 50 page Initiation Report by LifeSci Advisors, we explain the scientific support for Stemline's development candidates and the business plan to take these programs through approval. The report provides a deep discussion of all clinical data supporting the SL-401 and SL-701 CSC-targeting oncology programs. The report examines the landscape for targeted cancer therapies such as tyrosine kinase inhibitors and others, including recent success stories, and critically examines competing products and development programs.

Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, http://www.lifesciadvisors.com/clients/stemline. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.

The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.

About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.

Important Disclosures:
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.

Forward-looking statements:
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.

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