Novelos Therapeutics Announces Presentation Of Positive Results In Ongoing Phase 2 Neoadjuvant Breast Cancer Trial

Main Category: Breast Cancer
Also Included In: Clinical Trials / Drug Trials;  Cancer / Oncology
Article Date: 15 Dec 2008 - 4:00 PDT

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Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, announced that today the Braman Family Breast Cancer Institute at the Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine, in collaboration with Medical University of South Carolina Hollings Cancer Center, is presenting a poster highlighting further positive results from an ongoing Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer at the AACR Breast Cancer Symposium in San Antonio, TX. Alberto Montero, MD, Assistant Professor of Medicine at Sylvester, is the Principal Investigator. The poster, Daily injections of the glutathione disulfide mimetic NOV-002 ameliorates hematologic toxicities from neoadjuvant chemotherapy in breast cancer patients enrolled in the NEO-NOVO trial, and significantly increases circulating dendritic cells, can be viewed at http://www.novelos.com 'Our Products', 'NOV-002' section. NOV-002 is also the subject of an ongoing pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track.

The primary objective of this Phase 2 open-label, single-arm trial is to determine if preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel results in at least a 26% (12/46) pathologic complete response (pCR) rate versus the less than 20% expected with this same chemotherapeutic regimen alone. The trial is in the second stage of the Simon two-stage design. Full enrollment of 46 women is expected in the third quarter of 2009.

To date, 19 women have been enrolled, whereby 6 pCRs occurred in the first 15 women (40%) that have completed chemotherapy and undergone surgery. Furthermore, treatment with NOV-002 was associated with decreased hematologic toxicities and decreased use of growth factors relative to historical experience.

"We continue to observe in this ongoing trial a much greater rate of clinical and pathologic responses than typically seen with this standard neoadjuvant chemotherapy regimen in HER-2 negative breast cancer patients," said Dr. Montero. "We have also observed that responses have been greatest in estrogen receptor positive breast cancer patients, also known as luminal subtype, which typically are least sensitive to chemotherapy. Perhaps equally important, these patients have also consistently exhibited a lower than expected incidence and degree of hematologic toxicities."

"We are very pleased that NOV-002 continues to demonstrate positive results in this breast cancer trial and look forward to continuing our collaboration with Dr. Montero," said Harry Palmin, President and CEO of Novelos. "Meanwhile, we expect conclusion of our pivotal, fully-enrolled, 840 patient Phase 3 lung cancer trial in the second half of 2009."

Breast cancer remains a serious public health concern throughout the world. According to the American Cancer Society, approximately 180,460 women in the US are expected to be diagnosed with breast cancer in 2008, and approximately 40,480 are expected to die from the disease. Neoadjuvant or preoperative systemic chemotherapy is commonly employed in patients with locally advanced stage III breast cancer and in some patients with stage II tumors. Administration of neoadjuvant chemotherapy reduces tumor size, thus enabling breast conservation surgery in patients who otherwise would require a mastectomy. Furthermore, several studies have shown that pCR following neoadjuvant chemotherapy is associated with a significantly higher probability of disease free survival. However, less than 20% of patients with HER-2/neu negative breast cancer achieve a pCR with standard chemotherapy.

About Sylvester Comprehensive Cancer Center

Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine opened in 1992 to provide comprehensive cancer services and today serves as the hub for cancer-related research, diagnosis, and treatment at UHealth -- the University of Miami Health System. Sylvester handles nearly 1,600 inpatient admissions annually, performs 2,700 surgical procedures, and treats more than 3,700 new cancer patients. All Sylvester physicians are on the faculty of the Miller School of Medicine, South Florida's only academic medical center. In addition, Sylvester physicians and scientists are engaged in more than 200 clinical trials and receive more than $36 million annually in research grants. Sylvester at Deerfield Beach opened in 2003 to better meet the needs of residents of Broward and Palm Beach counties. A major expansion has recently been completed. Deerfield Beach offers appointments with nearly 30 physicians from 12 of Sylvester's 15 Site Disease Groups, complementary therapies from the Courtelis Center, and education and outreach events. http://www.sylvester.org

About Medical University of South Carolina Hollings Cancer Center

Hollings Cancer Center at the Medical University of South Carolina offers state-of-the-art diagnostic capabilities, therapies and surgical techniques and has multidisciplinary clinics that involve surgeons, medical oncologists, radiation therapists, radiologists, pathologists, psychologists and many other specialists seeing patients under one roof. Multidisciplinary care is provided in disease specific clinics such as thoracic, breast, head & neck, genitourinary, gastrointestinal, hematological, and pediatric cancers. Hollings Cancer Center is the largest academic-based cancer program in South Carolina. The Hollings Cancer Center is currently a developing National Cancer Institute designated cancer center and has more than $35M in cancer research funding. More than 1,000 people are currently participating on a cancer clinical trial at HCC. To expand patient access to clinical trials, MUSC Hollings Cancer Center has established the Clinical Trials Network (CTN). Partnering with nine cancer centers in S.C., the CTN broadens the reach of new research that may one day be the new standards of care. For more information, please visit http://www.hcc.musc.edu

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, the lead compound currently in Phase 3 development for lung cancer under a SPA and Fast Track, acts together with chemotherapy as a chemoprotectant and a chemopotentiator. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were originally developed.

Novelos Therapeutics, Inc.

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