Furiex Announces Results for Phase II Trial of PPD-10558; Advanced Breast Cancer Slowed by Roche, Novartis Drug Cocktails Print E-mail
By Staff and Wire Reports   
Thursday, 08 December 2011 19:24
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 8, 2011.

Furiex Pharmaceuticals, Inc. (NASDAQ:FURX)
announced top-line results from the Phase II trial of the investigational drug PPD-10558 in patients with statin-associated myalgia, or SAM. PPD-10558 did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study. The study enrolled patients with high cholesterol and a prior history of SAM, and evaluated recurrence rates for SAM over a twelve-week treatment period across the following three different treatment regimens: placebo; PPD-10558; and atorvastatin (Lipitor®). Patients did not report any significant differences in muscle symptoms, nor did they drop out due to SAM in significantly different percentages, among the three regimens. As expected, however, PPD-10558, a novel statin, did significantly lower LDL-cholesterol compared with placebo, and the compound also had a favorable safety profile.

We are disappointed with the results, given the promising pre-clinical profile of PPD-10558. We were surprised to see drop-out rates due to muscle symptoms in the placebo treatment group that were comparable to the PPD-10558 and atorvastatin treatment groups, said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. We, however, are confident that the study effectively evaluated the clinical hypothesis, and has provided a clear scientific result.

Given the results of this recent Phase II clinical trial, Furiex will not move forward with PPD-10558, said Fred Eshelman, Pharm.D., chairman of Furiex. We will continue to advance our other clinical programs and remain committed to our product portfolio and pipeline to support and create value for the company.

Furiex acquired an exclusive license rights in early 2007 from Ranbaxy Laboratories, Ltd. to develop, manufacture and market its novel statin PPD-10558 for the treatment of dyslipidemia. Furiex will owe a $1.0 million milestone payment to Ranbaxy upon completion of the final report for the Phase II study.

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Drugs from Roche Holding AG and Novartis AG (NYSE:NVS) which target different molecular drivers of breast cancer slowed tumor progression in separate studies that doctors say will change the way they care for patients.

Research released yesterday at the San Antonio Breast Cancer Symposium should alter the care of 80 percent of women with advanced tumors, said Jose Baselga, chief of oncology at Massachusetts General Hospital. Breast cancer is diagnosed in more than 230,000 women in the U.S. each year, making it the most common tumor type, and kills almost 40,000.

Roche's experimental drug pertuzumab delayed progression of metastatic cancer fueled by the HER2 protein for an extra 6.1 months when it was added to standard treatment with the company's Herceptin and chemotherapy. Novartis' Afinitor, approved for kidney and pancreatic cancer, slowed progression an additional 4.2 months when added to hormone treatment in women with treatment-resistant tumors driven by estrogen.

“These are two new therapies, targeted therapies, that will change the standard of care for women with metastatic disease,” Baselga, the lead author of both studies, said in a telephone interview. “They are elegant, they are hypothesis- driven and they are working through well-known mechanisms.”

The studies were funded by Roche and Novartis, both based in Basel, Switzerland. The results were simultaneously published in the New England Journal of Medicine. Roche requested U.S. approval of pertuzumab based on the findings this week and Novartis plans to file for expanded clearance for Afinitor by the end of the year.

Cancer Targets - About 25 percent of breast cancers are driven by HER2, a protein that tells malignant cells to grow and spread throughout the body. Roche's Herceptin, the first medicine approved to directly target HER2 positive cancers, blocks its receptors on the outside of the cell. Pertuzumab stops the protein from joining with HER3 and squelching an even stronger growth signal.

Afinitor was given to women with tumors fueled by estrogen, rather than HER2. While estrogen-blocking treatment is used first, the cancer sometimes resumes growing. Afinitor blocks a different pathway, known as mTor, that spurs the growth.

“We're beginning to see the promise of looking at tumors on the molecular level,” said Jennifer Litton, an oncologist at the University of Texas's MD Anderson Cancer Center in Houston, in an interview. “Now that we have the ability and it's financially reasonable, we are dissecting the tumors' molecular weaknesses and targeting them with smart bombs, and we're beginning to see improved outcomes as a result.”

Earlier Treatment-Treating the right patients even earlier with the targeted “smart drugs” may cure more women or make metastatic breast cancer a chronic and controllable disease, she said. Currently, breast cancer is considered incurable once it has spread, and treatment is designed to prolong survival.

Neither drug has yet to show longer survival for women with metastatic breast cancer, though the early results appear promising, particularly for pertuzumab, the researchers said.




Also Thursday:





3D Systems Corporation (NYSE: DDD)
announced today that Quickparts® assisted PediaVision® with the development and production of Spot, a wireless, handheld vision screening device that is easy to use and can capture results in less than one second.

Abbott (NYSE: ABT)
today announced the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial to evaluate the safety, efficacy and performance of the Absorb™ bioresorbable vascular scaffold (BVS) compared to the company's XIENCE PRIME™ Everolimus Eluting Coronary Stent System.

Bio-Reference Laboratories, Inc. (NASDAQ: BRLI)
announces best-ever quarterly and annual fiscal year results for revenues, earnings and cash.

BioRestorative Therapies, Inc. (OTCQB: BRTX)
("BRT") today announced that it has entered into a Material Manufacturing Agreement with the University of Utah.

Bristol-Myers Squibb Company (NYSE: BMY)
and AstraZeneca (NYSE: AZN) today announced results from a Phase 3 clinical study which showed that reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) seen at 24 weeks with the investigational compound dapagliflozin added to existing glimepiride (sulphonylurea) therapy, compared to placebo added to glimepiride, were maintained at 48 weeks in adults with type 2 diabetes.

Coronado Biosciences, Inc., (OTCBB: CNDO)
, a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that an oral presentation on CND0-109 will be given at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition to be held December 10-13, 2011 at the San Diego Convention Center in California.

EPIC Corporation (PINKSHEETS: EPOR)
(the "Company") announced that it is offering a substantial discount on its SOMNUS Sleep Pad™ to those persons suffering from a restless sleep due to chronic aches, pains, and stiffness or who just don't sleep through the night.

Generex Biotechnology Corporation (OTCBB: GNBT.OB)
today announced that positive interim Phase 2 clinical data from its ongoing study of a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) in HER-2 expressing breast cancer patients were presented at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

Genesis Biopharma, Inc. (OTCBB: GNBP), a biotechnology company developing targeted cancer immunotherapies, today announced that Anthony J. Cataldo, Chairman and Chief Executive Officer, and Martin Schroeder, a Company Director, will host investor meetings in San Francisco in conjunction with the JPMorgan 30th Annual Healthcare Conference, widely considered to be the largest healthcare-focused investment conference of the year.

Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of the first-of-its-kind clinical outcomes study for biomarker discovery applying next generation sequencing (NGS) for whole transcriptome profiling of archival formalin-fixed paraffin embedded (FFPE) tumor specimens.  

Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it will donate 445,000 vials of AmBisome® (amphotericin B liposome for injection) over five years to help the World Health Organization (WHO) treat more than 50,000 patients with visceral leishmaniasis (VL), also known as kala-azar.

The National Cancer Institute (NCI) has designated the LuViva™ Advanced Cervical Scan by Guided Therapeutics, Inc. (OTCBB: GTHP) as one of the agency’s successful investments for developing innovative products to fight cancer.

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (PINKSHEETS: KBLB)
is very pleased to announce that the University of Notre Dame has filed an international patent application for spider-silk technologies developed in collaboration with Kraig Biocraft Laboratories.

Laboratory Corporation of America® Holdings (NYSE: LH)
today announced that it has reached an agreement with the U.S. Federal Trade Commission allowing LabCorp to complete its acquisition of Orchid Cellmark Inc (NASDAQ: ORCH).

Neoprobe Corporation (NYSE Amex: NEOP), today announced that it will change its name to Navidea Biopharmaceuticals, Inc.

NeoStem, Inc. (NYSE Amex: NBS)
("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell based therapeutics development, today announced two appointments to its Board of Directors.

Shire plc (LSE: SHP, NASDAQ: SHPGY)
, the global specialty biopharmaceutical company, today announced positive Phase II results in a prospective clinical study of Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) as adjunctive therapy to primary antidepressant treatment in adults with partial or full remission of recurrent major depressive disorder (MDD) and significant, persistent cognitive impairments.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA)
– Ganetespib, a potent, second generation Hsp90 inhibitor, has demonstrated clinical activity in heavily pre-treated patients with HER2-positive and triple negative metastatic breast cancer according to Phase 2 clinical trial results presented by researchers from Memorial Sloan-Kettering Cancer Center at the San Antonio Breast Cancer Symposium (SABCS).

VIVUS, Inc. (NASDAQ: VVUS)
today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition,a peer-reviewed journal with broad, multidisciplinary readership.

WaferGen Biosystems, Inc. (OTCBB:WGBS), an emerging genomic analysis company, today announced that the company plans to deliver its corporate presentation at the Oppenheimer 22nd Annual Healthcare Conference at the Waldorf-Astoria, New York, NY, December 13-14, 2011.

World Health Energy Holdings, Inc. (OTCQB: WHEN) (PINKSHEETS: WHEN)
, a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today an LOI to acquire Rights to South Africa including a facility to provide a 46 MW power plant and to scale up to over 1,000,000 barrels of Biodiesel per year, a current market value of over 100 million USD.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Jonathan Lewis, M.D., Ph.D., Chief Executive Officer, will present at the Oppenheimer 22nd Annual Healthcare Conference on Wednesday, December 14, 2011, at 1:50 pm Eastern Time, at The Waldorf-Astoria in New York City.



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