Advaxis’ Cervical Cancer Treatment Comes to ASCO

The American Society of Clinical Oncology’s (ASCO) annual meeting is fast approaching, scheduled for May 31st to June 4th in breezy Chicago.  One of the many to present data this year is Advaxis, a biotechnology company that develops cancer and infectious disease immunotherapies.  The company’s keystone product, ADXS-HPV, is based on technology developed at the University of Pennsylvania and is currently being tested in five clinical trials.  The product targets HPV-related diseases, including cervical, head and neck and anal cancer.  The company will give presentations on two Phase II trials of the drug next month: one in the treatment of recurrent/refractory cervical cancer in Indian women and the other in the treatment of persistent or recurrent cervical cancer. Continue reading

Minimize Phase I Clinical Trials Delays with Early CRO Communication

Staying on schedule with planned timelines is both essential to maximizing a product’s potential and monstrously difficult to achieve.  New data that we’ve compiled in a recent study (see Figure 1) show an average of more than five months’ difference between planned and actual trial duration.  It’s clear that most of these delays are during patient enrollment, whether from low enrollment rates alone or amendments that companies end up making to the study protocol.  The exact problems that a clinical trial team runs into depend on the therapeutic area, the locations and abilities of the study sites.  But the clinical team should not discount the potential of its own expectations and communication methods to cause problems. Continue reading

Clinical Research in Asia: Factors to Consider

Access to treatment-naïve patients spurs companies to look beyond the borders of their own countries.  Top markets such as the United States are home to hundreds of millions of patients, but the clinical trial market has been saturated with thousands of protocols targeting fewer and fewer treatment-naïve patients.  As a result, companies have chosen to move outside their country borders to find both less-saturated clinical trial markets and more potential trial subjects. Continue reading

Save Time and Prevent Delays: Set Solid Plan at Start of Phase I

The pharmaceutical industry is feverishly searching for the next big drug to replace lost revenue from patent expirations on major blockbuster medicines.  Drugs with more than $30 billion in annual revenue lost patent protection in the last two years.  Patent expirations — and the accompanying lost revenue — place great strain on all areas of the company.  Much of that burden falls to clinical development teams charged with ushering investigational medicines to market.  Phase I is an important step for investigational compounds on the journey to regulatory approval.  But Phase 1 trials are not as straight forward as they once were. Continue reading

Phase IV Patients Are a Virtue

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with their competitors’ large-scale Phase III trials, but also with their own company’s later-stage studies. Continue reading

The Changing Face of Phase I Clinical Trials

As the pharmaceutical industry continues to focus on orphan diseases and other areas with unmet clinical needs like oncology, Phase I trials have adapted to better serve the medical community.  To quickly get new treatments to patients that need them most, Phase I clinical trials have undergone a face-lift.  While simple Phase I trials, primarily testing for safety and pharmacokinetics in healthy human volunteers, are still common, a new breed of Phase I trial has emerged — first-in-patient. Continue reading

Companion Diagnostics: A Growing, Beneficial Trend for Pharma

The drug industry’s reliance on companion diagnostics (CDx), particularly among large companies, has grown in recent years. According to the BasePair Group, CDx Partnerships with pharma have more than doubled between 2011 and 2012. Cutting Edge Information found in its study, “Companion Diagnostics and Biomarker Development: Partnership Strategies and Benchmarks” that 38% of surveyed companies had plans to launch a CDx in the next year. Continue reading

Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason. Continue reading