WALTHAM, Mass., Sept. 6, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announced today that ENCORE 301, a randomized, placebo-controlled phase 2 study of exemestane with and without entinostat hit its primary endpoint of an improvement in progression-free survival (PFS). The study showed that patients who received entinostat, a novel, oral small molecule inhibitor of class I histone deacetylases, with the hormone therapy exemestane, lived longer without their disease getting worse than people who received exemestane alone. Safety and efficacy results from the trial will be presented in a poster and an oral presentation at the American Society of Clinical Oncology (ASCO) Breast Cancer Symposium 2011 in San Francisco, CA this week.
Syndax Pharmaceutical's Positive Phase 2 Data Supports Potential For Entinostat In Advanced Breast Cancer
CoLucid Pharmaceuticals Raises $7.5 Million of Planned $9.5 Million
DURHAM, N.C., Aug. 30, 2011 /PRNewswire-iReach/ -- CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced today that it has raised $7.5 million of a planned $9.5 million convertible note financing from its existing investors to support further late stage development of lasmiditan. Participating in the financing were Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures.
CoLucid Pharmaceuticals Receives Clearance For Investigational New Drug (IND) Application For Lasmiditan For The Treatment Of Acute Migraine
August 20, 2011
CoLucid Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced that it has received clearance to proceed with clinical studies of lasmiditan (formerly known as COL-144) under IND 103,420 from the Food and Drug Administration (FDA).
Lasmiditan is a first-in-class oral tablet formulation of a Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called "ditans", and, unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.
Genentech, Plexxikon Cancer Drug Gets FDA OK
August 17, 2011
Genentech, the South San Francisco-based unit of Roche, and its Berkeley, CA-based Plexxikon, a unit of Daiichi Sankyo, said today that the FDA has approved their new drug for certain patients with melanoma that has spread through the body. The FDA said the companies can now start selling vemurafenib (Zelboraf) for patients who have mutations of a protein called BRAF that is implicated in their melanoma. The drug, which showed startlingly positive results in clinical trials, was approved ahead of the FDA’s legal deadline of Oct. 28, an action the agency rarely takes.
Syndax Pharmaceuticals Inc. Announces Issuance of EU Patent for Entinostat
WALTHAM, Mass., Aug. 17, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, today announced allowance by the European Patent Office for the patent application titled "N-(2-AMINOPHENYL)-4[N-(PYRIDINE-3-YL) - METHOXYCARBONYL - AMINOMETHYL]-BENZAMINE (MS-275) POLYMORPH B." This allowance follows the recent US issuance which was granted in June adding to the extensive patent estate for the Company's lead product, entinostat.
The patent covers the novel polymorph form B of the oral histone deacetylase inhibitor, entinostat, which is the specific polymorph being developed by Syndax for combination therapy with aromatase inhibitors for metastatic breast cancer and epidermal growth factor receptor tyrosine kinase inhibitors for advanced non-small cell lung cancer.
Vemurafenib Will Open Floodgates for Melanoma Genotyping
NEW YORK, August 10, 2011 – The genotyping era of melanoma management is poised to launch.
The era will start with genetic assessment of every patient with advanced-stage melanoma becoming the standard of care, as soon as the Food and Drug Administration approves marketing of vemurafenib, the small-molecule inhibitor of a mutated form of the BRAF gene. Reuters reports that approval is imminent, based on strikingly good results from a phase III study presented in June at the annual meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine (2011;364:2507-16).
"If and when [vemurafenib] is approved by the FDA, we will need some sort of commercially available test to assess patients [with unresectable stage IIIC or stage IV melanoma] for BRAF [mutations]," Dr. Richard D. Carvajal said in an interview after speaking at the American Academy of Dermatology’s Summer Academy meeting. "In a large, phase III trial, vemurafenib impacted survival in patients with tumors with a BRAF mutation. You’ll need to know the BRAF status to use [vemurafenib]."
Diabetes drug company Lumena raising up to $2M to reach clinical trials
June 24, 2011
Diabetes drug development company Lumena Pharmaceuticals aims to harness a benefit that diabetics receive from gastric bypass surgery and deliver it to those patients in the form of a pill.
The Durham, North Carolina-based company plans to start clinical trials on its experimental drug this year. To get there, Lumena has raised $500,000 in a round that could go up to $2 million with funding so far coming largely from Durham venture capital firm Pappas Ventures.
N.C. diagnostics firm LipoScience files for $86M IPO
Diagnostics company LipoScience aims to become North Carolina’s next public company.
Raleigh, North Carolina-based LipoScience has filed with securities regulators plans to raise up to $86.2 million in an initial public stock offering. It’s the second time LipoScience has flirted with a public stock offering. The company filed IPO plans in 2001, only to withdraw them in 2002 due to market conditions. But recent market conditions have improved; LipoScience’s IPO would follow the Durham company Tranzyme Pharma‘s (NASDAQ:TZYM) $48 million public offering in April.
LipoScience plans to use proceeds from its stock offering to expand its sales and marketing and fund continued R&D for new tests to supplement an already commercialized blood test to gauge the risk of cardiovascular disease. LipoScience is targeting the cholesterol testing market, which represents an estimated 75 million tests each year in the United States.
Last year, LipoScience recorded more than 6 million orders for its lipoprotein test and the company reports that from 2006 to 2010, test orders have increased at a compound annual growth rate of approximately 30 percent. That growth has been helped by insurance industry acceptance of the test. The NMR LipoProfile test is covered by a number of payors including Medicare, TRICARE, WellPoint, United HealthCare and several Blue Cross Blue Shield affiliates.
“We plan to significantly increase our geographic presence across the United States to expand market awareness and penetration of the NMR LipoProfile test, with the goal of ultimately becoming a clinical standard of care,” the company said in the filing.
LipoScience’s proprietary blood test counts the number of lipoprotein particles in a blood sample in order to gauge cardiovascular risks. LipoScience’s patented technology uses nuclear magnetic resonance to test for lipoproteins, which the company says are a better measure of cardiovascular risk than cholesterol levels.
The testing technology was developed at North Carolina State University by biochemistry professor James Otvos, who is now the company’s chief scientific officer.Otvos founded LipoScience in 1994 and by 1999, the company had developed tests to sell to clinicians and diagnostic laboratories. Investors in the company include Durham, North Carolina-based Pappas Ventures and Three Arch Partners, a Bay Area venture firm.
When LipoScience pulled its IPO plans nine years ago, the company’s revenue was $18.5 million. According to LipoScience’s most recent filing, the company generated $39.3 million in 2010 revenue. The company turned a profit of $4.3 million last year. But the filing notes that although LipoScience recorded profits in 2009 and 2010, it incurred a $500,000 loss in the first quarter of 2011. The company does not expect to be profitable this year or in coming years as it expands its growth strategy for its NMR LipoProfile test and develops new diagnostics. The company is also developing tests for diabetes and other diseases.
LipoScience expects that its latest diagnostic device should raise the market potential for its blood tests even more. Right now, blood samples using LipoScience’s tests must be sent to the company’s Raleigh headquarters to complete the testing because it’s the only facility with the proper equipment. But the company has developed a machine, called Vantera, that will allow institutions or laboratory testing facilities to complete that testing at their own sites. Vantera has already been site tested at a number of facilities across the country, including the Mayo Clinic and the Cleveland Clinic. LipoScience plans to file with the U.S. Food and Drug Administration for 510(k) clearance on Vantera by the end of this year.
Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C
NEW HAVEN, Conn., June 22, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.
Tesaro Garners $101,000,000 Series B Financing Round
June 21, 2011
TESARO is a privately held oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products.
TESARO plans to develop one or more compounds for oncology indications, including the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors express an ALK fusion protein; recent clinical proof-of-concept has been demonstrated for ALK inhibition in this patient population. The Series B financing will fund further development of these programs and expansion of the pipeline.
