Advanced ECG biomarkers from iCardiac Technologies provide hope for pharma development pipelines

The mood in the pharmaceutical development world is not good. Fewer new products being approved despite rising R&D expenditures, and many marketed products are under threat because of safety and efficacy concerns.There are several reasons for the dearth of new products and rising cost of pharmaceutical development. One major challenge is the FDA's requirement for so-called Thorough QT (TQT) studies to determine whether a drug may induce prolongation of the QT interval on ECGs in the healthy volunteers who comprise the Phase I study population.As Alexandra (Sasha) Latypova and Anthony Fossa from iCardiac Technologies, Inc. --a company whose board I serve on-- write in the current issue of Drug Discovery & Development:

The purpose of the TQT study, as stated by regulators, is to decide whether more extensive ECG monitoring is necessary in subsequent development... In reality, however, a positive TQT study or even QT prolongation detected in preclinical studies most often leads to termination of the drug development program, as both sponsors and regulators have become increasingly risk-averse in the wake of the recent, high-profile, market withdrawals of several blockbuster drugs.Prolonged QT as a biomarker has been widely-criticized for its high rate of false-positives and false-negatives. Consider the case of cisapride (Propulsid), a drug for gastrointestinal motility disorder. When the drug was evaluated for cardiotoxicity in humans using FDA-required testing, cisapride exhibited a small prolongation of the QT interval and consequently was considered safe for marketing. Once on the market, cisapride was associated with numerous arrhythmic events, including 341 cases of life-threatening cardiac arrhythmias with 15 sudden-cardiac arrests over a period of six years.[T]he litigation costs of false-negatives can be astronomical—class action suits and legal fees alone for cisapride exceeded $100 million. The conservative regulatory guidance has now dramatically reduced the probability of a false-negative QT study. However, false-positive QT studies produce an enormous “silent” burden on society. A false-positive QT study may cause an unnecessary termination or adverse labeling for an inherently safe drug and thus lead to lack of access to new medicines for patients that need them while at the same time contributing to the skyrocketing costs of new drugs. Some examples of false-positive QT drugs that did make it to market include moxifloxacin (an antibiotic), amiodarone (an anti-arrhythmic), tamoxifen (anti-neoplastic) and ziprasidone (an antipsychotic). All are associated with significant QT prolongation but do not have pronounced arrhythmogenic properties at therapeutic doses.

iCardiac is developing advanced cardiac safety biomarkers in order to overcome the limitations of TQT. Success will increase the chance that the next moxifloxacin, amiodarone, tamoxifen and ziprasidone make it to market, while protecting us from the next cisapride. I look forward to doing my part to help the company succeed.I interviewed iCardiac's Chairman and CEO, Mikael Totterman last year.Accept credit card todayReading credit reportsLog home insuranceConsolidation debt loan mortgage secondDebt consolidation informationCredit card applications onlineCreditreportsBest rates on life insuranceInstant approval cardsCredit repair forumImproving credit scoresTexas health insurance providerLong term care insurance businessDebt consolidation advice blogsOnline credit scoresLong term care insurance priceStudent loan servicing centerInstant auto loanRefinance your california home mortgageGroup disability income insuranceHealth insurance association guide to long term careCredit score definitionBest credit card ukDebt consolidation non profit organizationRead credit reportsLow fee payday loanCredit card processing ratesAverage national credit scoreInsurance swinger life styleOn my credit reportCredit reporting agenciesTenant credit reportsCalifornia home equity loansSmall business health insurance quotesDebt settlement inGood credit scoreInstant credit reportsInsurance life leadsTransunion credit reportsLong term care insurance policyCanadian credit card applicationCredit reports for landlordsCredit card application formsHealth insurance for senior citizenStop credit card offerDebt consolidation serviceDebt it settlement yourselfDirect loans student loansCredit repair tips lettersCredit reporting agencyCredit card company abuseRefinance st charlesLow term life insurance rateTerm life insurance companyDisney chase credit cardHealth insurance rateEmerge credit card servicesExtended auto warranty californiaCredit card application canadaGuaranteed issue life insuranceCredit report scoreAuto loans bad credit onlineAuto loan interest ratesExcellent credit score numberCredit card apr 0Small group health insuranceCounseling credit card debtInsurance discovery health sexual secretsElan credit card servicesUp credit reportsLoan rates home equity loansTerm life insurance protectionCommercial loanGas credit card applicationFree instant credit scoreCitibank credit card applicationFree home owner insurance quote