Bristol Myers Squibb Announces CheckMate -76K Trial Results of Opdivo (nivolumab) for Adjuvant Treatment in Stage IIB/C Melanoma

Bristol Myers Squibb ($BMY) have announced that the Phase 3 CheckMate -76K trial evaluating Opdivo (nivolumab) as a single agent in the adjuvant setting in patients with completely resected stage IIB/C melanoma met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo at a pre-specified interim analysis. No new safety signals were observed at the time of the analysis.

CheckMate -76K is part of BMS’ development program studying Opdivo and Opdivo-based combinations in earlier stages of cancer, which currently spans seven tumor types.

CheckMate -76K is a randomized Phase 3, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB/C melanoma.

The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.

Formula 1 technology in drug trials

Doctors are using Formula 1 technology to test the effectiveness of experimental medicines.

Smart sensors used by McLaren to track the performance of their cars on the track are being used for the first time in clinical trials of new drugs.

GlaxoSmithKline (GSK) hopes that by precisely tracking the movements of patients they will get earlier feedback on whether a drug helps to get them back on their feet.
Currently doctors try to estimate a patient's response to a drug by asking how far and how often they walk.
But sensors that are taped to the neck can monitor patients day and night, providing a far more objective - and accurate - measure of activity.

The accelerometer gives detailed data on a patient's physical activity

Dr Caroline Hargrove, technical director at McLaren Applied Technologies, is adapting the sensors and the software used to analyse the data for human use.
"Rather than how fast you have gone round a lap, it's how many minutes of walking you have done," she said.
"A simple, small sensor gives you so much context to go on. It captures something quite subjective - the level of activity you do.
"It's something difficult to get out of people."
Sky News was allowed to test one of the sensors over several days.

McLaren's Dr Hargrove is adapting the F1 technology for a new purpose

The 3D accelerometer is so accurate that scientists were able to differentiate periods of relative inactivity while working, from general movements around a home or office.
They can even tell how often people move while in bed to give an indication of their sleep quality.
GSK is using the sensors to in drug trials on patients who have rheumatoid arthritis or have suffered a stroke.

The data can even give an idea of the quality of someone's sleep

Dr Ravi Rao, a consultant rheumatologist and medicines development leader at the company, said the data can be analysed to determine the duration of an arthritis patient's stiffness in the morning.
"These quality of life measures, in terms of how a patient is functioning with a disease, are incredibly important - more important sometimes than a blood test or a physical examination."
The pharmaceutical company hopes the technology will speed up drug development.
Currently, it takes 10 years and hundreds of millions of pounds for a medicine to go from lab bench to clinic.

The sensors can help people who have arthiritis, says GSK's Dr Rao

Dr Steve Mayhew, leading GSK's partnership with McLaren, said: "By getting an early understanding of whether our medicine is behaving as we expect, it allows us to make a decision on whether to continue to develop it.

"Crucially we won't recruit patients to an experimental study where we don't think there will be any benefit to them."

from: sky news

CDA Bill to be redrafted in line with Parliamentary panel recommendations

The Central Drug Authority Bill, which was virtually rejected by the Parliamentary panel, will be redrafted in line with the recommendations of the panel pertaining to the exclusion of exports from its purview.

 

Sources in the health ministry said that the bill would be amended in accordance with the recommendations of the Parliamentary Standing Committee on Health and the suggestions from the stakeholders. The recommendations of the Prof Ranjit Roy Chaudhury expert panel on clinical trials will be taken into consideration while revamping the bill, sources said.

 

Commenting on the report of the Parliamentary panel report, Drug Controller General of India (DCGI) Dr G N Singh also felt that the bill had to be redrafted now.

 

One of the key changes in the bill can be the exclusion of exports from the  the bill and also amendment to the definition of clinical trials. “The Committee has been informed that the exporter has to ensure that the pharma units whose drugs are proposed to be exported comply with the Good Manufacturing Practices (GMP) guidelines issued by the World Health Organisation (WHO). Hence, no further regulation on the export of such drugs would be necessary,” according to the report of the panel.

 

“The Committee is of the view that if export of drugs is brought within the ambit of Drugs and Cosmetics Act/Rules, it will severely affect exports of drugs and put domestic pharma manufacturing units/exporters at serious disadvantage. The Committee therefore decided that the word 'export' may be omitted from this clause and consequential amendments may be made to other clauses of the Bill,” it said.

 

“The Committee decided that in the definition of clinical trial provided in (af) (i) the words “any drug” should be substituted by “any new drug”, since generally Bioavailability/Bioequivalence studies of approved drugs are conducted in healthy volunteers with recommended doses,” the report said.

 

“As regards the definition of clinical trial in respect of cosmetics provided in (af) (ii) the words “of a cosmetic including a new cosmetic” should be substituted by the words “of any new cosmetic” as the cosmetics containing approved ingredients are generally considered safe. The Committee, therefore, recommends that clinical trials of all cosmetics may not be required to be regulated. Clinical trials of only cosmetics having new ingredients (new cosmetics) should be regulated,” the panel said.

 

“In the definition of clinical trial in respect of medical device provided in (af) (iii) line 2, after the words “study of a” the words “medical device” should be omitted as the medical devices are approved in the country after ensuring their safety and effectiveness. Clinical trials of all medical devices may not be required to be regulated. Therefore, Committee recommends that clinical trials of only new medical devices should be regulated,” it added.

Ruling on clinical trials is in national interest: Azad

 Union Health Minister Ghulam Nabi Azad on Wednesday admitted that the recent Supreme Court ruling on, and stringent regulations for, clinical trials had set drugs research back in India. But he was hopeful that the sector would gather pace again.

“We received a setback because not many pharmaceutical companies are coming forward for clinical trials now. There has been a 50 per cent drop in clinical trials after stringent regulations were put in place, but we are hopeful that they will pick up in the coming days,” he told The Hindu.

The changes were meant to protect the national interest and to do justice to those who participated in the trials, he said.

The Ministry has laid down tough rules to make companies liable for the death of, or injury to, any drug trial subject. Even permission for such trials is given after a rigorous process. Simultaneously, the Supreme Court suspended 157 previously approved trials pending review by new committees. This slowed down new trials, especially those by foreign companies or those being lined up with foreign collaboration.

The Supreme Court’s order came in response to a public interest litigation petition by a health rights group, Swasthya Adhikar Manch, which said trials in India had exploited poor patients, who were not even aware that the drugs were still being tested.

India made sweeping changes to the rules of the Drugs and Cosmetics Act, 1940, which governs clinical trials, making it mandatory for the principal investigator of the pharmaceutical company to reveal the contract between the subject and the company to the Drugs Controller-General of India. “Earlier, the informed consent of the persons on which the trials had been conducted was often manipulated by the companies to the disadvantage of the subjects,” Mr. Azad said.

Videography of the process of informed consent, with the full knowledge of the participant, had been made mandatory, and any death during a trial would have to be reported to the DCGI within 24 hours, he said.

The Drug Testing Advisory Board was the only body for granting permission for trials. 

Chennai hospital gets approval for clinical trials

 The drug controller general of India has granted approval to Dr. K.M. Cherian’s Heart Foundation and Frontier Lifeline Hospital to conduct clinical trials of their tissue-engineered porcine pulmonary artery, tissue-engineered bovine jugular vein and tissue-engineered bovine pericardium.

Heart Foundation has been given permission to carry out clinical trials on human beings.

In a release, Dr. Cherian said, “Now that we have got approval, the trial will be done and manufactured tissues will be sent to leading medical colleges for clinical tests.” Following the trials, Heart Foun- dation will start manufacturing and supplying the tissues.

54 deaths reported during clinical trials in three years from 2010 in India

The Union health ministry has said that total number of deaths related to clinical trials during three years from 2010 were 54 while the casualties and injuries during the year of 2013 were still to be assessed.

 

In a written reply in the Lok Sabah recently, Health Minister Ghulam Nabi Azad said the number of deaths related to clinical trials in the year 2010, 2011 and 2012 were 22, 16 and 16 respectively as per the available data. “The reports of Serious Adverse Events (SAEs) of injuries and deaths, received in the current year 2013 are under examination. Compensations have been paid in 21 cases of deaths related to clinical trial in 2010 and in all cases in 2011 and 2012. In one case of 2010, the compensation remained unpaid as whereabouts of the legal heir could not be traced by the investigator and his team in spite of their best efforts,” he said

The Minister also gave details of the steps taken by the government to strengthen the approval procedure for clinical trials, monitoring mechanism and payment of compensation to ensure that safety, rights and well-being of clinical trial subjects are protected. 

“In light of the Supreme Court Order dated 21.10.2013, it has been decided that for all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent, is also required to be done while adhering to the principle of confidentiality. This is applicable to the new subjects to be enrolled in all clinical trials including Global Clinical Trials,” the Minister said.

“The Drugs and Cosmetics Rules, 1945 have been amended vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines. . The Drugs and Cosmetics Rules, 1945 have been amended vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance. Another amendment was done vide Gazette Notification G.S.R No. 72(E) Dated 08.02.13 making registration of the Ethics Committees mandatory and specifying requirements and guidelines for registration of Ethics Committee,” he added.

Source: Pharmabiz

Videorecording of consent for clinical trials mandatory

 The Union Health Ministry has made audio-visual recording of the informed consent of each subject mandatory in a clinical trial. This is in addition to obtaining his/her written consent.

This decision comes in the wake of the Supreme Court pulling up the Ministry for lack of transparency in clinical trials.In its October 21, 2013, order on a writ petition filed by an NGO, the Swasthya Adhikar Manch, Indore, the court said with respect to five global clinical trials, which was approved by the Drugs Controller-General of India (DCGI) office from January 1, 2013, to August 31, 2013, an appropriate provision should be made or administrative direction issued, ensuring that audio-visual recording of the informed consent process was done and the documentation preserved, adhering to confidentiality principles.

In his order, DCGI G.N. Singh said all sponsors/investigators/institutes/organisations and other stakeholders involved in clinical trials should adhere to this requirement with immediate effect.

Reacting to this, the Indian Society for Clinical Research — an association of professionals involved in clinical trials — said lack of guidance and direction on operational and logistical issues of managing the audio-visual recording process like the kind of equipment to be used, and where and how information should be stored could leave room for ambiguity and inconsistencies in execution.

More clarity was required on how confidentiality of patients should be protected and maintained in an ‘audio-visual’ context and what processes needed to be followed in instances where, for religious and socio-cultural reasons, patients might not want to be videographed, the association said. 

Source: The Hindu

Lilly's Enzastaurin flunks Phase III trial for Diffuse Large B-Cell Lymphoma

Eli Lilly and Company have announced the Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. There were no new safety findings, and the safety data were consistent with previously disclosed studies. 

Patients enrolled in PRELUDE had histologically confirmed DLBCL with an International Prognostic Index (IPI) score of three to five at diagnosis. The IPI is a simple, clinical tool that is used to predict survival outcomes for patients with DLBCL. Patients enrolled also achieved a complete response or complete response-unconfirmed to cyclophosphamide, doxorubicin, vincristine, and prednisone, plus rituximab (R-CHOP) therapy. Patients were randomized in a 2:1 fashion to receive enzastaurin or placebo.

Treatment continued until patients developed progression of disease, unacceptable adverse events, or completed three years of therapy.

Lilly will stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately $30 million. Lilly's pipeline has more than 20 molecules, including two Phase III molecules in five different tumor types

Clinical Trials in India plummet after stringent norms - Article from The Hindu

Clinical trials of drugs in India have seen a drastic fall this year after toughened norms were introduced following Supreme Court directives.

 

Not only have the number of trial approvals in the country reduced, there has also been a significant

reduction in the number of sponsoring pharma firms applying for such approvals.

 

Official Health Ministry data shows that until January 31 this year, only six trials had been approved. Even these pertained to older applications where the Drug Controller General of India had asked the applying firms to make some amendments.

 

Sources say until April, only around 12 approvals have been granted by the DCGI for trials of drugs in India. Pending applications for trials as of today are just 70.

This is in sharp contrast to the past when the number of Global Clinical Trials (GCTs) approved for conduct in India was in hundreds

 

Though in 2008 the DCGI had granted just 65 approvals for trials, the number in 2009 rose sharply to 391. The trend continued with a whopping 500 GCTs being allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012.

 

Admitting that there has been a drastic fall in fresh applications for conduct of global clinical trials of drugs in the country, DCGI GN Singh told PTI, “The safety and well being of Indian subjects participating in clinical trials is the foremost in our minds.

 

“This is why the Government has tightened the norms putting the onus of safety of participants on firms conducting the trials. It is for the first time that such norms have been put in place.”

As many as 2,262 people died in these trials during the past five years, leading to a public outcry and Supreme Court intervention for stricter norms for holding drug trials. The apex court had rapped the Health Ministry for allowing Indians to be used as “guinea pigs” in the conduct of drug trials.

 

Also before the new rules were put in place, the average compensation awarded per death was a meagre Rs 2.2 lakh as per Health Ministry data.

 

The Government recently notified new rules for the conduct of drug trials in India, making it mandatory for investigators and sponsors to address issues of serious adverse events such as death of subjects involved in trials and fixing a formula for grant of adequate compensation in such cases.

Pharma firms, the sources say, have been discouraged to apply for new trials due to recent stringent norms which the Government has notified as a precondition for grant of approvals.

 

The new rules which came into force this year, for the first time, propose a formula for minimum compensation to be paid by the sponsoring firm in case of serious adverse events such as death or injury of the trial participant.

 

New rules also require the setting up of independent ethics committees under medical institutes to monitor ongoing drug trials.

 

These committees must now be registered with the DCGI prior before the conduct of clinical drug trials.

 

In the older system, pharma company hosting the trial could set up its own committee and have its own investigators for inquiring into serious adverse events.

 

Currently pegged at USD 500 million, India’s clinical research market was projected to more than double and cross USD one billion mark by 2016 driven by a large and easy-to-access population with much lower cost than in the developed world.

 

Source: The Hindu

Are Pharma Companies increasing the number of Voluntarily initiated Phase IV trials

The study, “Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management,” conducted by Cutting Edge Information found that 82% of surveyed companies’ post-marketing trials are voluntarily initiated. That percentage is an increase from 61% of Phase IV trials that were voluntarily initiated by drug manufacturers in 2006.

I took a quick look at the number of phase IV trials at the ClinicalTrials.gov registry and surprised to see that the number of Phase IV trials disclosed by Pharmaceutical companies was on a decline. Is the disclosure limited to trials that are conducted as part of Life Cycle Managment of the drugs or are the companies conducting trials purely for commercial reasons and do not have an obligation to report those.

Here is what ClinicalTrials.gov reflects on the phase IV trials run by pharmaceutical companies.



Interview With Pfizer Director on Virtual Clinical Trials

Found an interview of Pfizer Director, regarding virtual clinical trials.

Virtual Trials - Still REMOTE ?

Just as I wrote about virtual trials (interestingly came to know about it around the "Partnership in Clinical Trials" conference where there was a session on this topic), there was an update on this topic supporting my initial apprehensions of the practicality of this fascinating approach. 

Miguel Orri, Senior Director of clinical sciences at Pfizer, at the ‘Partnerships in Clinical Trials’ conference, have indicated that the virtual trial "REMOTE" did not recruit.

Reasons:

• It did not ‘appreciate what patients need’ - Patients don’t want to divulge their medical information online, or to a pharma company.
• Another problem is that many patients affected by overactive bladder disorder are elderly, and do not use the internet as regularly as younger patients. (I've seen many granny's are on FaceBook these days.. shouldn't be a problem in the near future)
• Importantly, the aspects of the process were ‘quite complicated and tedious

Plan of Action from Pfizer:

Pfizer is collecting feedback from participants in the US trial to improvise the model. They have also now taken steps to revamp the model by creating a new call centre to helps patients through the initial steps. 

This bitter start in US should help them with their European virtual trial, dubbed REMOTE 2.0. Pfizer said they would contract a recruitment vendor to help patients through the initial setup process, making it easier for patients. All participants in the European trial will also receive a communication device to help with updating their e-diaries.

source: InPharm

Previous Articles:
Virtual Clinical Trials - Pfizer leads the race

Virtual Clinical Trials - Pfizer leads the race

I was very much interested to know what this is all about when I saw the Program of "Partnerships in clinical trials" conference that started yesterday at The Marriot World Cener, Orlando, FL, USA. Really interesting idea.

How about running clinical trials at a subject's home ?! Yes, that is all about Virtual Clinical Trials.

Pfizer have become the forerunner of this new approach in clinical trials. They have decided to leverage the advantages that the digital world provides to overcome the difficulties faced while conducting a usual clinical trial. Difficulties range from finance, logistics, partnering, enrolling patients, labs, ethical and legal issues, storage, dispensing of IP, etc. in a clinical trial. If not all the difficulties, many of those seems to be overcome in virtualtrials (which has limitations of its own!)

Pfizer began the first ever virtual clinical trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) to determine whether the results of the pilot ‘virtual trial’ can replicate those of a previously completed Phase IV study with tolterodine tartrate (Detrol LA)

• 600 patients from around 10 states across the US
• Screening is online
• Consent online using video/multimedia
• Subjects will manage their own trial activity and report results directly to a trial investigator,
• Study drugs will be shipped to the subjects' homes rather than to study sites
• Study participants will get $25 for each online assessment and/or laboratory visit completed, up to a total of US$175.
• No study site visits

Potential advantages would be real time and reliable data collection, a lot of time, money and effort saved. A lot of paperwork is eliminated and of course audit findings will be clear.

“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials,” said Dr Freda Lewis-Hall, executive vice president and Chief Medical Officer of Pfizer.

But to train almost 600 people on the systems to use, procedures to follow will be tough job for Pfizer and the advent of technology is itself a limitation of its use. And the main disadvantage of this would be that this system is more applicable to conditions where there are a lot of patient reported outcomes and those that does not involve any complex diagnostic or treatment procedures. That again raises a concern of the scalability of this system. Moreover, I cannot imagine something like this to be a reality (at least in half a decade) in an African country or a developing nation where the cost of healthcare is still a economical burden on the patients.

Least, this does spice up the clinical trial experience for trial personnel and subjects who are tech savvy!

Here is the program at "Partnerships in Clinical Trials" confernence. No wonder Pfizer dominates this  session. They lead the race with no visible competitors.

Monday, March 5, 2012—Executive Summit Day and General Session Kick-Off 9:30 Chairperson's Opening Remarks,PFIZER INC. 9:45 Virtual Trials— what are They? - PFIZER INC. 1030 Making a Study Different: What is Truly Innovative About the Virtual Trial Approach? - GENENTECH (ROCHE) 11:00 Break 11:30 Case Study: New Results From Pfizer's Mobile- Powered Virtual Clinical Trial Outsourcing Pilot Program, PFIZER INC. 12:30 Lunch 1:30 Assess the Legal Risks and Considerations of Virtual Trials, GORDON & REES LLP. 2:15 Examine Collaboration of Technology Companies Needed to Support the Virtual Trial Model 2:45 Industry Collaboration: How Should We Approach and Work With the FDA to Create a Regulatory Process for Virtual Trials? - PFIZER INC. AND JANSSEN 3:30 Summits End

FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies

Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”

Certain medical products may elicit different responses in women than in men. This may be due in part to basic differences in men and women, including genetics, hormones, body size, diet, and sociocultural issues. In addition, certain variables associated with women, such as size or certain illnesses, may be responsible for certain differences between men and women in the safety and effectiveness of medical devices.

 

A 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies found that while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics. A 2009 study of cardiovascular device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9 percent women.

The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies. In addition, it covers issues regarding statistical analyses of sex differences and how to report sex-specific information in summaries and labeling for approved devices.

Devices intended for single-sex use, of course, would not be expected to address potential sex differences.

The FDA is seeking input on this draft guidance during a 90 day public comment period. The draft guidance can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm.

CytRx Announces Favorable Initial Results from its Ongoing Phase 1b/2 Clinical Trial in Patients with Soft Tissue Sarcomas

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced favorable response and safety indications from a group of patients with advanced solid tumors (principally soft tissue sarcomas) in the Company's ongoing Phase 1b/2 clinical trial with INNO-206, its tumor-targeting conjugate of the commonly used chemotherapeutic agent doxorubicin. Patients in this portion of the Phase 1b/2 clinical trial received three different dose levels of INNO-206 to determine its maximum tolerated dose.

In the initial Phase 1b portion of the clinical trial, 12 patients, primarily with advanced soft tissue sarcomas, have received one or more administrations of treatment with INNO-206 in three-week cycles. The Company determined a maximum tolerated dose of INNO-206 that delivers a doxorubicin equivalent of 3½ times the standard doxorubicin dose administered to sarcoma patients. CytRx is currently enrolling additional patients who will be treated at that dose to gather further response data in parallel with the planned international Phase 2b clinical trial scheduled to start this quarter.

Of five patients who have completed four cycles with INNO-206 at the maximum tolerated dose, one patient has exhibited a partial tumor response (greater than 30% tumor shrinkage) and four patients have stable disease. Unexpectedly, a large, painful oral sarcoma that caused difficulty eating in one patient was greatly reduced following a single INNO-206 treatment. Common side effects reported to date from the Phase 1b/2 trial include low neutrophil (white blood cell) and platelet counts, minor mouth ulcers and mild nausea, which are expected side effects of doxorubicin.

"Initial data of response and safety from INNO-206 in this portion of the Phase 1b/2 trial are very important," said CytRx President and CEO Steven A. Kriegsman. "Although these initial results are from a limited number of patients, the individuals treated were very advanced in their disease and had previously received multiple different chemotherapy agents, including doxorubicin, so we are pleasantly surprised to observe stable disease, much less tumor shrinkage, in these cancer patients. We believe these early indications bode well for the potential success of our international Phase 2b clinical trial in patients who have advanced disease but were not previously administered chemotherapy."

"The response from this small group of patients treated with INNO-206 is encouraging and we look forward to sharing the full, final data from the Phase 1b/2 clinical trial in a presentation at ASCO 2012," said Sant P. Chawla, M.D., F.R.A.C.P. The Phase 1b/2 clinical trial is being conducted at the Sarcoma Oncology Center in Santa Monica, Calif. under the direction of Dr. Chawla, a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication.

In September 2011, CytRx announced completion of the maximum tolerated dose portion of the Phase 1b/2 trial, which included 12 patients. The patients from the early portion of the trial were evaluated for tumor response after four cycles of INNO-206. The Company also announced plans to add 12 patients to the Phase 1b/2 trial to receive INNO-206 at the maximum tolerated dose, and six of those additional patients have already been enrolled.

About INNO-206

INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. Doxorubicin is a standard chemotherapeutic treatment for a variety of cancers and is used either alone or in combination with other chemotherapy agents. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues. This conjugate formulation has the potential to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment, which could lead to improved efficacy.

CytRx holds the exclusive worldwide rights to INNO-206 -- a platform technology designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In addition to doxorubicin, several other chemotherapy agents have been attached to the linker used for INNO-206, including paclitaxel, cisplatin and methotrexate, and may be incorporated into future clinical development by the Company.

About Advanced Soft Tissue Sarcomas

Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis and limited options. Progression-free survival for patients with advanced soft tissue sarcomas is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival and are quite toxic.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx plans to initiate a Phase 2b clinical trial as a treatment for soft tissue sarcomas in 2011, following its Phase 1b/2 clinical trial. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.

Middle East to be the Future in Clincial Trials

Global pharmaceutical companies are currently seeking emerging markets to conduct clinical trials due to the increase in drug development costs and the demand to advance drugs faster.

The Middle East is forecasted to be one of the fastest growing markets for clinical research outsourcing based on availability of the required infrastructure, access to necessary patients, faster timelines and lower costs compared to other markets.

Clinical Trials Partnership Middle East Summit will assemble all stakeholders from leading research sites, clinical research organisations, regulators, government organisations and pharmaceutical companies to provide strategies and knowledge on critical issues such as regulatory compliance, optimising clinical trials, overcoming clinical trials challenges and identifying business opportunities in the Middle East region.

Taking place between 28^th & 30^th November 2011 in Dubai, this three day summit is a must for all executives, senior level directors or directors from the pharmaceutical, biotech, clinical research organisations and clinical investigators who are looking to discuss the advances of the regions clinical trials market.

Clinical Trails Partnership Middle East Summit kicks off with an essential interactive workshop on day one, looking at a comprehensive overview of 'Good Clinical Practice' in relation to the regional and international guidelines for conducting clinical trials.

The next two days are packed full of exciting and innovative discussions, crucial networking opportunities and exciting round table discussions where delegates will be able to share their views and knowledge on subjects such as 'Improving the quality of clinical trials by using standardised performance metrics'.

Event Director for Clinical Trails Partnership Middle East Summit, DoaaSaid, described the conference as'A vital event for the increasing success and on-going improvement and competitiveness of the regions clinical trials market.'

Delegates in the field will come away from the summit with all the tools needed to better their practices, making them more competitive and efficient. They will also have the chance to make vital relationships and connections in the scheduled networking periods.

Registration for this event is now open on the website http://www.clinicaltrialsmena.com. Delegates booking before 19th September 2011 will receive a discount of up to $450.

For more information about the Clinical Trails Partnership Middle East Summit please contact Jihan Mohammed,

Marketing Manager,

IQPC Middle East,

Email enquiry@iqpc.ae

call +971-364-2975

ACRO to launch campaign to allay negative public image about CROs

Enraged over the negative propaganda that the Indian subjects, especially the poor and the illiterate, are being used as guinea pigs by the Clinical Research Organizations (CROs), pharmaceutical companies and other organizations involved in the clinical trials and bioequivalence studies, the Association of Contract Research Organizations (ACRO) will soon launch a publicity blitzkrieg to allay the misconceptions about the CROs in the country.

During the last two months there has been misleading reports about the role and responsibility of the CROs and pharmaceutical companies involved in the clinical trials in India, an ACRO leader said.

ACRO, in the interest of the general public and the CRO industry would soon be coming up with the facts and figures for apprising all concerned on the objectives of the clinical research industry, the key role it plays in aiming at the general population health and in bringing the expensive drugs within the reach of the common man, the leader said.

Ever since the drug authorities raided and unearthed irregularities at Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each, there has been a public criticism that the Indian subjects, especially the poor and the illiterate, are being used as guinea pigs by the CROs.

Under this background of growing public criticism against this dubious activities, the ACRO held an emergency meeting on July 29 in Mumbai which was attended by over over 35 CROs, pharmaceutical companies engaged in clinical research and representatives from Confederation of Indian Industries (CII).

Condemning the recent events which have been misrepresented without fully presenting all the facts, the ACRO decided to come out with a detailed information and a clarification regarding all the issues concerned. ACRO pledged its support to undertake initiatives that would create positive impression amongst participating volunteers and subjects in clinical research. “Clinical research is important for the development of drugs and it is our responsibility to build a strong scientific foundation in the interest of billion lives. Outcome of research should be used in positive and meaningful discussion for deriving better healthcare benefits to the nation,” an ACRO leader who actively participated in the meeting said.

He added that ACRO has pledged in supporting these initiatives and work closely with all stakeholders in ethical conduct of clinical research. All ACRO members conduct studies only after obtaining all the required approvals including from the DCGI and Independent Ethics Committees.

Source: Pharmabiz

Chaos in Clinical Research

The recent irregularities reported in conducting of clinical trials by Axis Clinicals, a Hyderabad based CRO, in Andhra Pradesh has once again brought to focus the questionable ways in which clinical trials are being done in India by the pharmaceutical companies and their agents. The report said that the CRO conducted bio-equivalence studies for an anti cancer drug on poor women early this year without securing their informed consent. The episode came to light only last month when some women belonging to this group complained of severe body ache, joint and chest pain and extreme weakness after taking the drug. A few of them even had difficulty in walking. The office of the DCGI raided the premises of the CRO after report came in the media and suspended its license. Axis also will be disallowed from conducting all bio-availability and bio-equivalence studies at their centre for some time now. Investigation carried out by the DCGI officials found irregularities in procedures such as recruitments of subjects and in taking their informed consents. The DCGI also found that the ethics committee at the centre was not functioning independently as required under the existing ICMR guidelines. Many such violations by CROs while conducting clinical trials in India were reported in the recent past and actions were taken against the offenders. But, these offences keep occurring in various parts of the country and very few of them get reported in the media.

After the action taken against the Hyderabad CRO, the office of the DCGI decided to audit all CROs in the country to ensure that the bio-availability and bio-equivalence studies are performed strictly in accordance with the regulatory provisions and prescribed guidelines. The DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai. The basic problem with the clinical research in the country is that the sector is not at all effectively regulated. The health ministry has been working for last ten years to put in place a set of comprehensive rules to regulate clinical research with huge flow of contract research jobs into the country. But that has not happened yet. Ethics Committees at most of the trial sites are not active with no monitoring of the trials. What the country has a set of guidelines after amendment of the Schedule Y of Drugs & Cosmetics Act and it is not yet notified. That is what emboldens the MNCs and CROs to conduct trials as they do it now. Now in the case of CROs, a set of draft rules for their mandatory registration was issued by the DCGI some time in July 2009 after it was approved by the Drug Technical Advisory Board. But the registration process is still not in place. The move to make registration mandatory for CROs was taken after finding a spate of irregularities in conducting trials in the past. In short, the slow decision making process in the health ministry is the prime reason for the whole chaos in clinical research front. The matter has to be taken up by the health minister seriously and urgently if this critical sector of the pharmaceutical industry has to function with some order.

Source: Pharmabiz

DBT completes draft guidelines on preclinical trial data for similar biologics

The Department of Biotechnology (DBT) has drafted a set of guidelines for conducting pre-clinical trials of biosimilars in the country. The Department is now waiting for draft notes on clinical trials for biosimilars from the Drug Controller General of India (DCGI) to complete this work on guidelines.

Manufacture and marketing of biosimilars in India are currently governed by the Environment Protection Act of 1970 and the Drugs and Cosmetic Act. Even though biosimilars is regulated under these provisions of these acts, there is no specific set of rules this sector in the country today.

Emphasising on the need to have proper guidelines to regulate the growing biosimilar market, Dr K K Tripathi, advisor, DBT said that his office has been working for some time to provide industry with a unique set of rules that will help them in their growth.

“Through this guideline, we aim to address the seething problem of lack of regulation in biosimilars in the country. The biggest benefactor of this will be the industry as it will give them more credibility in the market. The guidelines on pre-clinical trials have been completed after taking into consideration the recommendations and comments from all stakeholders and associations from the industry.”

It is believed that the market for biosimilars will change significantly by 2015, as many well known biologic drugs are on the verge of patent expiration.

“We are constantly working for the betterment of the industry and that is why we are keen to complete the guidelines on biosimilars fast. However, to complete the work on guidelines we need data on clinical trials from the DCGI, only after that can we proceed further in this,” Dr Tripathi informed.

DBT have been working on the pre clinical guideline from last one and half year. Biosimilars enter the markets when a biodrug patent expires. Unlike generics, biosimilars are not produced chemically but biologically, taking a biotech drug as a reference.

DCGI withdraws approval given to Axis Clinicals for BE studies after probe confirms allegations

The Drugs Controller General of India (DCGI) has suspended the clearance given to Hyderabad-based Axis Clinicals for conducting bio-availability and bio-equivalence studies at their centres in Miyapur 'in public interest', in the wake of the recent controversies for allegedly using women in Piduguralla as trial subjects.

“The Drugs Controller General (India)’s South Zone Office, Chennai and Sub-zonal office, Hyderabad has conducted investigations in the matter of recent reports about certain irregularities in conduct of clinical study by Axis Clinicals Ltd., Hyderabad in violation of the norms specified in Schedule Y of the Drugs and Cosmetics Rules. The investigations have revealed various irregularities in conduct of the above said studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process. The investigations were conducted on 20th and 21st June 2011 at the bio-equivalence study centre of Axis Clinicals Ltd. situated at Serlingampally, Miyapur, Hyderabad,” according to official statement here.

The Drugs Controller General (India) has therefore suspended the approval of the said firm for conducting all bio-availability and bio-equivalence studies at their centres in Miyapur, Hyderabad in public interest, it said.

The office of the DCG(I) has further decided to investigate the working of all bio-availbility and bio-equivalence study centres in Andhra Pradesh within a period of two months to ensure that such studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.

“Axis Clinicals Ltd., Hyderabad had conducted bio-equivalence studies on Exemestane tablets in its Serlingampally, Miyapur, Hyderabad centre during the period 27th January 2011 to 15th February 2011. It was alleged that the firm had conducted study by administering the anti-cancer drug to the poor women in Piduguralla town of Andhra Pradesh without securing their informed consent,” the statement added.