CV Therapeutics : Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases

Sept. 2 , 2008 - CV Therapeutics, Inc. (Nasdaq: CVTX) announced that the company has enrolled the first patient in a Phase 1 trial of CVT-3619, a novel oral compound for potential treatment of cardiometabolic diseases. The U.S. Food and Drug Administration recently accepted the Company's investigational new drug application for CVT-3619, a partial A1 adenosine receptor agonist.

This Phase 1 trial will assess the safety and pharmacokinetic profile of CVT-3619 in healthy volunteers. The Phase 1 program will provide early data on the compound's potential effects on circulating levels of free fatty acids, which are associated with high blood lipid levels, insulin resistance and other cardiometabolic risk factors...

..."CVT-3619 represents a first-in-class agent that appears to inhibit the release of free fatty acids from fat cells and has the potential to meet a tremendous unmet need by potentially treating both dyslipidemia and diabetes. We look forward to the clinical development of this innovative medication... CV Therapeutics' Press Release -

Roche NimbleGen CGH Arrays Enable Detection of the Genomic Disorder Resulting in Diabetes

July 30, 2008 — Chromosomal rearrangements leading to genomic disorders are often mediated by low-copy repeat regions of the genome (e.g. segmental duplications). Roche NimbleGen CGH arrays offer expanded probe coverage in these regions. Using this technique, the authors of a recently published paper¹ identified a recurrent reciprocal genomic rearrangement of chromosomal region 17q12 in fetal samples with congenital anomalies that is also associated with pediatric renal disease and epilepsy. The results emphasize the importance of evaluating de novo structural variation events in pediatric diseases other than mental retardation and the importance of duplication architecture as a predisposing factor for disease.

Genomic disorders result from nonallelic homologous recombination (NAHR) between low-copy repeat regions of the genome and occur in approximately 1 in 1,000 live births. The phenotypes of many of these known genomic disorders include developmental delay and mental retardation. Therefore, screening for novel genomic disorders has largely focused on patients with cognitive disability and/or peripheral nervous system defects... Roche NimbleGen's Press Release -

Lilly and Boehringer Ingelheim : New data show Duloxetine maintained pain reduction for more than six months in patients with DPNP

19 August 2008 – Duloxetine hydrochloride maintained pain reduction in the treatment of diabetic peripheral neuropathic pain (DPNP) for more than six months, according to new data presented at the 12th World Congress on Pain in Glasgow, Scotland.

The open-label study, which aimed to evaluate long-term maintenance of effect of duloxetine 60 mg once daily, is the first to assess the efficacy of duloxetine in DPNP beyond three months. The study enrolled 216 patients with DPNP who began eight weeks of treatment with 60 mg of duloxetine once daily. Over this initial eight-week period, 53 percent (N=115) of enrolled patients experienced clinically significant improvement in pain reduction (defined as at least 30 percent pain reduction) as measured by the Brief Pain Inventory (BPI) 24-hour average pain rating. This group of responders was maintained on duloxetine 60 mg (N=103) once daily for up to 26 weeks to evaluate sustained pain reduction. Results at study end showed that the reduction in pain was maintained in 74.8 percent (N=77) of the sustained responders with 60 mg duloxetine over the full study period.


“DPNP is a chronic, potentially disabling, condition requiring treatment over a long period of time,” said Vladimir Skljarevski, M.D., lead author of the study and a neurologist and medical fellow at Lilly Research Laboratories. “This study showed duloxetine reduced pain over a six-month period, making this the longest data analysis of duloxetine for the treatment of DPNP.”... Boehringer Ingelheim's Press Release -

Home Diagnostics: FDA Clearance for TRUE2go, TRUEresult No-Coding Blood Glucose Monitoring Systems

Aug 20, 2008 - TRUE2go(TM) is World's Smallest Blood Glucose Meter, Designed to Help Patients Better Manage Their Diabetes On-the-Go - Home Diagnostics, Inc. (NASDAQ:HDIX), a leading manufacturer and marketer of diabetes testing supplies, announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the world's smallest blood glucose meter, TRUE2go(TM), and for TRUEresult(TM), the company's latest advanced performance, no-coding meter for at-home testing.

Small enough to twist and attach to the top of a vial of test strips, TRUE2go offers patients the convenience of anywhere, on-the-go testing to help them better manage their diabetes. TRUEresult, the latest state-of-the-art, high performance meter, offers patients advanced monitoring capabilities at an affordable price. In clinical testing, both systems achieved a high degree of accuracy and repeatability, and were considered to be easy to use by people with diabetes.

Both new meters are compatible with the company's new TRUEtest platform of blood glucose test strips featuring the company's patent-pending, state-of-the-art GoldSensor(TM) laser accuracy and TRUEfill(TM) beveled tip. These advanced features ensure highly accurate test results and first test success by allowing for greater sampling precision and consistency... Home Diagnostics' Press Release -

Activx Biosciences : Positive Phase Ib and IIa Clinical Trial Results for KRP-104, a Flexible Dosing DPP-4 Inhibitor for Type 2 Diabetes

August 20, 2008 — Activx Biosciences, Inc., a wholly owned subsidiary of Tokyo-based Kyorin Pharmaceutical Co., Ltd., announced topline results from their Phase Ib and Phase IIa clinical trials with KRP-104, a dipeptidyl peptidase-4 (DPP-4) inhibitor, for the treatment of type 2 diabetes. In Phase IIa, KRP-104 was shown to be well tolerated and efficacious in the treatment of hyperglycemia in patients with type 2 diabetes resulting in highly significant improvements in glycemic control compared to placebo.

The open labeled, cross-over, Phase Ib trial of KRP-104 in the US enrolled 28 patients with type 2 diabetes and showed equivalent efficacy on glucose-lowering to a competitive drug.

The randomized, double-blind, placebo-controlled, multi-center Phase IIa trial in the US and India enrolled 220 patients with type 2 diabetes inadequately controlled on metformin alone. The study evaluated the safety, tolerability, and efficacy of a total daily dose of 120 mg of KRP-104, administered either as a once daily (QD) dose or as a split dose of 60 mg (BID) added to stable metformin therapy for 12-weeks of treatment. Both dosing regimens provide greater than 95% inhibition of DPP-4 during daytime hours, but the BID dosing regimen provides this high level of inhibition continuously, whereas the QD dose results in considerably less DPP-4 inhibition overnight... Activx Biosciences' Press Release -

Amylin and Lilly : Context for FDA Alert for BYETTA

Aug. 26, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) in a conference call provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA(R) (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin's and Lilly's corporate websites after the call.

Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies... Amylin Pharmaceuticals' Press Release -

Intercept Pharmaceuticals Raises $25 Million, Funding Will Support Completion of INT-747 Phase II Clinical Trials...

July 29, 2008 - Intercept Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapeutics for the treatment of chronic fibrotic and metabolic diseases, announced the completion of a $25 million equity financing by Genextra S.p.A. This financing was in lieu of the previously contemplated $20.5 million second tranche investment under the Genextra-led $41 million financing announced in May 2006.
Mark Pruzanski, M.D., Intercept's founder, President and CEO, commented, "This financing is recognition of the progress we have made with our lead compound INT-747, as well as recent exciting milestones achieved in our preclinical programs. Genextra's strong backing will enable us to complete our Phase II clinical trials while continuing to advance our pipeline of internally discovered novel FXR and TGR5 agonists."


Patient enrollment is well underway in three Phase II clinical trials of INT-747, Intercept's first-in-class farnesoid X receptor (FXR) agonist. The clinical program of INT-747 consists of two studies in patients with primary biliary cirrhosis (PBC), a chronic autoimmune liver disease, and a third study in Type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD). INT-747 has been granted orphan drug designation by the U.S. Food & Drug Administration for the treatment of PBC... [PDF] Intercept Pharmaceuticals' Press Release -

SemBioSys submits IND for safflower-produced insulin to U.S. FDAn

July 29, 2008 - SemBioSys Genetics Inc. (TSX:SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has submitted an Investigational New Drug (IND) application for safflower-produced recombinant human insulin to the United States Food and Drug Administration (FDA). The IND application contains a physical, chemical and structural analysis of safflower-produced insulin to a reference standard, results from 28-day sub-chronic toxicology studies in two species of mammals, demonstration of pharmacodynamic function in animals and describes a cGMP process for the production of safflower-produced insulin. SemBioSys plans to initiate a Phase I/II clinical study of its safflower-produced insulin in the fourth quarter of 2008... SemBioSys Genetics' Press Release -

Silence Therapeutics to receive $1.9m Milestone Payment as Pfizer, Quark commence Phase II Trial

30 July 2008 – Silence Therapeutics plc (AIM: SLN), a leading European RNAi focused biotechnology company, announces that its partner, Quark Pharmaceuticals Inc (“Quark”) together with Pfizer, has commenced a Phase II clinical trial with RTP-801i-14 (PF-4523655), a small interfering RNA (siRNA) therapeutic product based on Silence’s AtuRNAi technology. Its initiation triggers a $1.9 million milestone payment to Silence from Quark.


The study is designed to evaluate the effectiveness of the candidate in improving visual acuity compared to laser treatment in patients with diabetic macular oedema. The Phase II study is being funded and is conducted by Pfizer Inc in collaboration with Quark.
Pfizer in-licensed RTP-801i-14 from Quark in a deal announced in 2006 for the treatment of age-related macular degeneration (AMD) and other ophthalmologic and non-ophthalmologic indications... Silence Therapeutics' Press Release - Quark Pharmaceuticals' Press Release -

Formation of GlycoMark, Inc., a Joint Venture to Develop and Commercialize Novel Biomarkers for Diabetes

July 17, 2008 - Toyota Tsusho America, Inc. (New York, NY) and Nippon Kayaku Co., Ltd. (Tokyo, Japan) announced the formation of a new joint venture company, GlycoMark, Inc., dedicated to the discovery and commercialization of novel biomarkers for diabetes. The company is located in New York, NY and the Piedmont Triad Research Park in Winston-Salem, NC.


Toyota Tsusho America, Inc., Nippon Kayaku Co., Ltd., and the BioMarker Group (Kannapolis, NC) have worked together as partners to commercialize the GlycoMark(R) diabetes blood test over the past few years prior to establishing the new company.

With increasing clinical acceptance and commercial success of the GlycoMark(R) blood test, a solid foundation has now been built to position GlycoMark, Inc. as a leader in the field of diabetes diagnostics... [PDF] GlycoMark's Press Release -

Eisai China : License Agreement in China for alpha-Lipon 300 STADA for Diabetic Neuropathic Pain

July 30, 2008 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced that Eisai China Inc. (Headquarters: Suzhou, President: Yukio Akada, “ECI”), a wholly-owned subsidiary of Eisai Co., Ltd., has entered into license agreement with Health Vision Enterprise Ltd. (Headquarters: Hong Kong, Directors: Alex Leung and Zona Yim, “Health Vision”), a sales subsidiary of STADA Arzneimittel AG (Headquarters: Germany, “STADA”), for sales and repack of -Lipon 300 STADA® (generic name: -lipoic acid) in China. -Lipon 300 STADA® is a treatment for diabetic neuropathic pain developed by STADA.

With this agreement, ECI will take over sales promotion activities for -Lipon 300 STADA® in China from Health Vision from August 1. In addition, ECI will prepare for filing an application for repacking the product at its Suzhou plant. Upon approval, ECI will assume repacking and sales of -Lipon 300 STADA® in China.

-Lipon 300 STADA® is a therapeutic agent for diabetic neuropathic pains developed by STADA, and has been on the market in China since 2005. It relieves neuropathic pain associated with diabetes by its antioxidant effect, which reduces overproduction of oxygen species and normalization of glucose metabolism... Eisai's Press Release -