Update for: asfotase (from Enbonia), CX-4945 (from Cylene Pharmaceuticals), and tesetaxel (from Genta)

• Enbonia reported positive result from the phase II juvenile trial using its ENB-0040 or asfotase as the treatment of hypophosphatasia.  Asfotase is being used as the enzyme replacement therapy in patients with hypophosphatasia, a rare, inherited, and sometimes fatal metabolic bone disease.  Patients with hypophosphatasia has low level of alkaline phosphatase that could lead to rickets in infants and children and osteomalacia in adults.  The FDA has given asfotase the fast track status in 2009 and it also has orphan drug designation in both the US and EU. Source
• Cylene Pharmaceuticals has initiated the phase I trial using CX-4945, an oral CK2 inhibitor, as the treatment of multiple myeloma.  In addition, Cylene has announced that it has a 12 million financing from its existing investors: Sanderling Ventures, HBM BioVentures, Novartis bioventures, BioVenture Investors, Lilly Ventures, Mitsuit & Co and Morningside Venture Investments.   Source
• The phase II trial using tesetaxel, a combination product of both paclitaxel and docetaxel, developed by Genta Incorporated as the treatment of advanced bladder cancer has been initiated.  The trial will assess the safety and efficacy of the new combination drug product against cisplatin and gemcitabine.  The overall response rate is the study's primary endpoint.   Source

Stedivaze or adadenoson of Clinical Data showed safety and tolerability as pharmacologic stress agent in patients with COPD and Asthma

• The phase I trial using Stedivaze or apadenoson of Clinical data showed that it was safe and tolerable in patients with asthma and COPD.  Stedivaze is a potent and highly selective Adenosine A2a receptor agonist.  It's currently being developed as the pharmacologic stress agent for myocardial perfusion imaging.  It's currently in the phase III trial which was initiated in November 2009.  Pharmacologic stress agent is often used in myocardial perfusion imaging to increase blood flow in patients undergoing diagnostic test. Source

Update from Oxygen Biotherapeutics' OxyCyte

• The FDA has given its approval to Oxygen Biotherapeutics to start the phase IIb trial using Oxycyte(R) emulsion, a proprietary perfluorocarbon (PFC) based oxygen emulsion, as the treatment in patients with traumatic brain injury.  Source
• Earlier in the week, Oxygen BioTherapeutics and the US Navy have expanded their Cooperative Research and Development Agreement (CRADA).  Under the agreement, preclinical trial swine models will be included to assess the safety and efficacy of Oxycyte(R) for spinal cord injury. Source

Update on Rosiglitazone

• Update on Avandia
• Today the European Medicine Agency issued a statement recommending the discontinuation of the marketing authorization for any medications that contain rosiglitazone.  The affected medications are Avandia, Avandamet, and Avaglim.  
• On the same day, the US FDA decided not to withdraw Avandia from the market but will restrict its use as the treatment of type 2 diabetes.  Source
• Avandia is currently being marketed in the US by GSK. In order to get access to Avandia, patients need to not be able to have adequate control of their blood sugar with other medications and unable to take Actos (pioglitazone).  Source

quick update on clinical trial: Qnexa, Miraversen, PNT2258

Quick update on Clinical Trials!

• The clinical trial using Qnexa Controlled Release Capsule of Vivus, a combination of phentermine and topiramate, as the treatment of obesity showed a significant and sustained weight loss compared to placebo.  A new drug application has been submitted to the FDA for approval in December, 2009.  The FDA will make its decision on October 28, 2010.  Source
• Miraversen, a microRNA product of Santaris, is now in a phase II clinical trial to treat hepatitis C infected patient.  Miravirsen is developed using Locked Nucleic Acid (LNA) of Santaris to inhibit miR-122. Source
• PNT2258, a single-stranded oligonucleotide developed by ProNAi, has entered the phase I dose-escalation study in patients with advanced solid tumor.  PNT2258 utilizes SMARTICLES developed by Novosom to target Bcl-2 oncogene.    Intellectual property of SMARTICLES has recently been acquired by Marina Biotech.  Source

Novartis received approval from the US FDA to market Gilenya or fingolimid, an oral sphingosine 1-phosphate receptor (S1PR) modulators, as the treatment of relapsing forms of multiple sclerosis

Novartis received approval from the US FDA to market Gilenya or fingolimid, an oral sphingosine 1-phosphate receptor (S1PR) modulators, as the treatment of relapsing forms of multiple sclerosis.   Gilenya has been shown to reduce frequency of MS relapses.  It was shown to have a safe and good tolerability profile in over 2600 patients.  Source

Pasireotide of Novartis is shown to be effective in reducing cortisol level in phase III trial of Cushing's Disease.

The phase III trial using SOM230 or pasireotide as the treatment of Cushing's Disease showed that the investigational product is effective in reducing the level of cortisol in the body.  Pasireotide is a pituitary-directed therapy which hopes to decrease cortisol secretion.  Pasireotide had the Orphan Drug Designation in the US and Europe.  Source

Pradaxa or dagibatran of Boehringer Ingelheim has received approval recommendation from the US FDA Cardiovascular and Renal Drugs Advisory Committee for the treatment of stroke prevention in patients with atrial fibrillation.

Pradaxa or dagibatran of Boehringer Ingelheim has received approval recommendation from the US FDA Cardiovascular and Renal Drugs Advisory Committee for the treatment of stroke prevention in patients with atrial fibrillation.  Dabigatran etexilate is an oral anticoagulants/direct thrombin inhibitor.  It has been approved to be used as primary prevention of venous thromboembolic events in adult patients who had elective total hip or elective total knee replacement surgery.  Source

Pharmapodia Podcast : 09 20.2010

Hello Monday & Goodbye Weekend!

Here are the highlights for the day!

Enjoy!

• The phase III trial using a combination therapy of dapagliflozin and glimepiride of Bristol-Myer Squibb and AstraZeneca in the treatment of type 2 diabetes patients showed significant reduction in the A1c level compared to the monotherapy of glimepiride.  
•  The clinical trial using Reducer, an implantable product of Neovasc, to treat heart disease patients with refractory angina has enrolled its first patient.
•  The phase IIb, 36-week active extension study conducted by Teva Pharmaceuticals and Active Biotech using two doses of laquinimod, an oral immunomodulator, as the treatment of relapsing remitting multiple sclerosis showed that laquinimod provided a signification reduction in gadolinium-enhancing T1 lesions compared to the baseline.  
• The Chinese State Food and Drug Administration has approved the clinical trial application submitted by Fibrogen to conduct clinical trial using FG-4592 as the oral therapy in anemia associated with chronic kidney disease in China.
• The phase III trial comparing the effectiveness of Onbrez Breezehaler, containing indacaterol - an ultra-long acting beta agonist, and salmeterol showed that OnBrez produced a significantly reduction in breathlessness in COPD patients compared to salmeterol at the end of 12 week treatment.  
• The preliminary result of the phase III trial using Northera or droxipoda, as the treatment of symptomatic neurogenic orthostatic hypotension in patient with primary autonomic failure met its primary endpoint which was a significant improvement in symptoms associated with the disease compared to the placebo group. 
• Peregrine announced that the Transformational Medical Technologies Program of the US Department of Defense’s Defense Threat Reduction Agency (DTRA) has added a 6-month extension to the original 2-year contract and provided an additional 2.4 million funding. 
• Parexel International and Eli Lilly have entered into a strategic functional service provider relationship under which Parexel will help Lilly setting up and monitoring clinical trial sites through Asian and Pacific Region.  

Update from Sanofi-Aventis: lixisenatide & Lantus

• The phase III trial using lixisenatide, a glucagon-like peptide-1 agonist under the development of Sanofi-Aventis, as the treatment of type II diabetis showed that lixisenatide provided significant reduction in A1C level compared to placebo group.  In addition, lixisenatide also provided significant reductions in blood glucose levels 2-hour after meals compared to baseline.  The most common adverse event or side effect was nausea.  Lixisenatide was originally developed by Zealand Pharma A/S and was licensed to Sanofi-Aventis. Source
• Sanofi-Aventis also announced at the EASD(1) that using data from different clinical trials, the company found combination of Lantus in addition to oral antidiabetic medication significantly reduce the A1C levels in patients with uncontrolled type 2 diabetes.  The most significant reduction in A1c level was seen in patient taking metformin. However, Lantus by itself produced significantly more hypoglycemic (low blood sugar) events compared to other oral antidiabetic therapies. In combination therapy, Lantus and metformin produced a significantly lower number of hypoglycemic events compared to others.  Lantus is an insulin glargine, a long-acting insulin that is often used in type 2 diabetes.  Source

Celldex Therapeutics initiates the phase IIb trial using genbatumumab for the treatment of advanced breast cancer

• CDX011 or gembatumumab, of Celldex therapeutics is now in the phase IIb clinical trial for the treatment of advanced breast cancer.  CDX011 of Celldex therapeutics has been given the Fast Track Designation by the FDA in May.  
• CDX011 is gembatumumab, an antibody, that has been conjugated with glycoprotein NMB that often expressed in advanced, refractory breast cancers.   
• The company plans to enroll 120 patients.  The study primary endpoint: response rate, progression-free survival and overall survival.  The company plans to have the results of this study out by the 4th quarter of 2011.
• Source

Prometheus signed a license agreement with Tarrot Laboratories

• Prometheus and Tarrot Laboratories have signed an exclusive research collaboration and license agreement.  Together, they will work to identify genetic and serologic markers that have been found to have associations with clinical responses to medications belong to anti-tumor necrosis factor therapy (Cimzia, Humira, and Remicade).  These medications are currently being used to treat Crohn’s disease.  Under the agreement, Prometheus will have exclusive rights to intellectual properties as well as any diagnostic tests that originate from this agreement.  In addition, Tarrot will receive milestone payment and royalties. Source

Another news for Actos or pioglitazone from FDA

The FDA recently issued the preliminary safety data on Actos (pioglitazone).  The agency found no association between the use of Actos and the risk of bladder cancer from these preliminary data.  However, the risk increased in patients taking the drug for longer period of time or having more drug accumulated in the body. 

The review is still ongoing and no definitive association has been made in regard to Actos and bladder cancer.

Pioglitazone or Actos is an antidiabetic agent that belongs to Thiazolidinedione therapeutic class.  It works to increase the ability of body (cells) response to insulin by acting on the peroxisome proliferator-activated repceptor.  It does not however increase insulin secretion from the pancreas.  As it increases the body sensitivity to insulin, it hopes to decrease blood glucose at the same time.  However, data have suggested the risk associated with the use of pioglitazone and cardiac adverse event.  A US Boxed Warning has been issued.  The USA cautions the use of pioglitazone or Actos in Heart failure patients (it could exacerbate pt's heart failure). 

Due to the way it works, edema is a common adverse effect (Up to 15% of patients taking pioglitazone could experience edema).  in addition, upper respiratory tract infection is another common adverse events.

Source

FDA MedlinePlus Info