Category Archives: News

June 3, 2016- Chandigarh: ClinSoft team member will be attending the 3 day CPhI 2016 conference in Shanghai, China. CPhI China is the most comprehensive pure pharma focused event for domestic and international pharmaceutical companies in Asia.
 

Bringing together over 35,000 pharma professionals from more than 120 countries around the world, attendees get the opportunity to meet, network, do business, share ideas and shape the future of the Chinese pharmaceutical industry.  

Meet us at the conference or just email us to schedule a meeting. 

We’re looking forward to see you there.  

About ClinSoft Clinical Research
 

ClinSoft is a pioneer in strategic development and global clinical solution partner for Pharmaceutical, Biotechnology and Medical device industry. Our immense experience in wide range of services as well as maintaining cost effective, timely and quality deliverables make us the favorite service provider for our clients. 

We at ClinSoft adhere to maintain high ethical standards and our team and clients believe in our core values. Our clinical platforms enable clients to work collaboratively throughout the drug development process with features like user friendliness, central data access, peer to peer interaction, work satisfaction and reliable data security.

A Scientific leader in regenerative medicine for neurological disorders and the United States subsidiary of SanBio Co., Ltd., announced today that they are now able to conduct the world’s first global Phase 2 clinical trial for chronic traumatic brain injury with allogeneic stem cells in Japan. The 30-day review period of Clinical Trial Notification of the regenerative cell therapy SB623 (hereinafter “this medicine”) for traumatic brain injury in Japan, which was submitted to Pharmaceuticals and Medical Devices Agency (PMDA) as of March 7, 2016, has passed without further concern.
The STEMTRA “Stem cell therapy for traumatic brain injury” trial will study the safety and efficacy of SB623 cell therapy in treating patients with chronic motor impairments following a traumatic brain injury. Enrollment began in the United States in October 2015 and, going forward, will include clinical trial sites and patients in Japan. The trial will enroll 52 subjects, and the inclusion of Japanese patients is expected to accelerate overall enrollment.
Damien Bates, Chief Medical Officer and Head of Research at SanBio, said, “SanBio’s regenerative cell medicine, SB623, has improved outcomes in patients with persistent motor deficits due to ischemic stroke, and our preclinical data suggest it may also help TBI patients. This is the first global Phase 2 clinical trial for TBI with allogeneic stem cells, and the approval to conduct the trial in Japan, as well as in the United States, brings us one step closer to determining SB623’s efficacy for treating those who suffer from the effects of traumatic brain injury.”
SB623 cells are modified allogeneic mesenchymal stem cells, derived from bone marrow stromal cells isolated from healthy adult donors. When administered into neural tissue, SB623 cells promote recovery from injury by triggering the brain’s natural regenerative ability.
SanBio recently completed a US-based Phase 1/2a clinical trial for SB623 in patients with chronic motor impairments six months to five years following an ischemic stroke. The results suggested the medicine’s potential to improve motor function following a stroke. Based on these results, a Phase 2b randomized double blind clinical trial of 156 subjects began enrollment in December 2015.
Traumatic brain injuries can result from a variety of causes, including car accidents, falls, occupational hazards and sports injuries. The injury can lead to lifelong motor deficits, and there are currently no approved medicines for the treatment of persistent motor disability from traumatic brain injury. Therefore, this is an area of high unmet medical need.
Although the cause of the brain injury differs from ischemic stroke, the clinical manifestation of motor deficits is similar. As the mechanism of action and proposed route of administration are similar to the Phase 1/2a clinical study in stroke, it is anticipated that the results of this traumatic brain injury clinical trial will be similarly efficacious.
Takehiko Kaneko, head of Clinical Development in Japan at SanBio, said, “I’m very glad that SB623 can advance to a clinical development phase in Japan. We will proceed with the clinical development of SB623 as soon as possible, so that we can contribute to patients suffering from ongoing disability.”
Japan grants marketing approval for regenerative medicines earlier than any other country in the world due to an amendment to the Pharmaceutical Affairs Law in 2014. This amendment defined regenerative medicine products as a new category in addition to conventional drugs and medical devices, and the conditional and term-limited Accelerated Approval system for regenerative medicine products has started. Two regenerative medicine products have already gained marketing approval under this new system, and the government-led industrialization of regenerative medicine products has gradually been realized.
SanBio has begun the preparation of clinical trial facilities in Japan and expects early commencement of the clinical trial in 2016. They aim to market this medicine in Japan ahead of the world by taking full advantage of the Accelerated Approval system.
As announced in the news release on March 31, 2016 “Notice Concerning Borrowing of Funds,” SanBio concluded a contract with Mizuho Bank, Ltd. for borrowings based on a commitment line of credit. Through these borrowings and a portion of funds procured from the stock listing in April 2015, SanBio plans to cover the research and development expenses related to the program for treatment of chronic motor deficits secondary to traumatic brain injury using the SB623 cell product in Japan.

Govt. exempts academic institutions from taking DCGI permission; move a setback, say health experts
With the aim to speed up innovation and research in India, the Health Ministry has amended the Drug and Cosmetics Act, exempting clinical trials conducted at academic institutions from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI).
Public health experts say the move is a setback for those working towards a safer, more transparent clinical trials regime. The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials. In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.
Meanwhile, the latest amendment to the D&C Act follows recommendations by the Professor Ranjit Roy Choudhury Committee, which had suggested that academic research should be approved by the Institutional Ethics Committees. “We want to create a system in which research and innovation are not caught in red tape. This is part of the government’s ease of regulation reforms. Many students test existing drugs and their study is delayed because of permissions required from the DCGI. Now, their institutions’ ethics committees are authorised to allow them, which should nurture an environment of research in the country,” said G.N. Singh, DCGI, Central Drugs Standard Control Organisation.
Chances of misuse are obviously higher if you give anyone a free hand, said C.M. Gulhati, Editor ofMonthly Index of Medical Specialities. “The only defence for this decision can be that this is academic, not commercial, research. These are academic exercises. They cannot experiment with new molecules. The element of risk is lower but ethics committees need to be independent. It will depend on the institutions how they use it, which leaves a huge loophole,” he added.

The FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. It is caused by breathing in the spores of the bacterium Bacillus anthracis. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death. Anthrax is a potential bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air.

“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
Anthim’s effectiveness for treatment and prophylaxis of inhalational anthrax was demonstrated in studies conducted in animals based on survival at the end of the studies. More animals treated with Anthim lived compared to animals treated with placebo. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone.

The safety of Anthim was evaluated in 320 healthy human volunteers. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.

Anthim carries a Boxed Warning alerting patients and health care providers that the drug can cause allergic reactions (hypersensitivity), including a severe reaction called anaphylaxis. Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis. However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to outweigh this risk.

Anthim was developed by Elusys Therapeutics, of Pine Brook, New Jersey, in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Chandigarh, April 5, 2016: ClinSoft Clinical Research will be participating in the 2nd National Mega Pharma Job Fest- Cum Placement Drive 2016. ClinSoft will be hiring for multiple positions and vacancies. The Job Fest is open to pharmacy diploma holders, graduates, post-graduates and doctorates. ClinSoft had pleasurable experience in ISFC last year, which led us to conduct placement drive this year as well.
ClinSoft team members will be visiting the campus on April 10, 2015 to conduct the hiring procedure and selected candidates will get the opportunity to work with esteemed members of our organization.
ClinSoft team is always looking for the enthusiastic and motivated Freshers/Experienced professionals who could be a valuable addition to the team. We are looking forward to the success of this drive. So be there and grab the opportunity!

WASHINGTON:  A triple therapy treatment consisting of two experimental drugs and radiation therapy may help fight lung cancers that are resistant to current treatments, a new study has claimed.

Although the most common type of lung cancer – non-small cell lung cancer (NSCLC) – has recently seen major treatment advances in some genetic subtypes, other subtypes continue to evade effective treatment, researchers said.

Roughly 85 per cent of all lung cancers belong to the NSCLC type. Although there have been some advances in treating this disease, only two per cent of survivors live five years beyond treatment.
Drugs have been developed to target the ALK- and EGFR-mutated subtypes, and are to some degree effective, however, one genetic subset, NSCLCs with mutations in the gene KRAS have been resistant to conventional and targeted therapies.

The new study in mice has shown that cancers with KRAS-related gene mutations might benefit from a triple therapy with two experimental drugs plus radiation therapy.

“Currently there is a clinical trial underway to evaluate the combination of two cancer drugs, trametinib and palbociclib, made by two pharma companies for patients with solid tumours and melanoma,” said Bo Lu, Professor of Radiation Oncology at Thomas Jefferson University in US.

“Although further research in human subjects is needed to confirm the finding, our study suggests that we may be able to identify non-small cell lung cancer patients who are likely to benefit most from this combination of therapies,” ,Mr Lu said.

The researchers studied the KRAS-mutant subset in NSCLC cells and found that there was variation within this subset; some were more resistant to a drug that targeted the KRAS gene pathway than others.

An additional mutation in a protein called p16 appeared to be responsible for this difference.

After scanning a database of lung-cancer patient genotypes, the researchers saw that patients with the p16 mutation had a lower overall survival rate than those without the mutation.

In order to help make these resistant KRAS mutants more susceptible to therapy, the researchers combined the KRAS-targeting drug with another drug that would undo the effects of the p16 mutation.

They showed that the combination of the two drugs make these resistant cancer cells susceptible to radiation treatment.

The research could help identify the patients who could potentially benefit from a triple-therapy treatment.

The study was published in the journal Clinical Cancer Research.

In a study published in The Lancet Neurology, researchers found that an anti-seizure drug called phenytoin protected against nerve damage in people with optic neuritis.

Optic neuritis is a common symptom of MS, in which the optic nerve that carries visual information from the eye to the brain becomes inflamed and damaged. For some people, optic neuritis can be the first sign of MS.

Study leader Dr. Raj Kapoor, of the Institute of Neurology at University College London in the UK, and his team focused on patients with optic neuritis because inflammation and damage to eye nerves are simple to measure.

Specifically, the researchers set out to determine whether phenytoin could block sodium from entering axons in nerve cells; excess sodium in nerve cells leads to an overproduction of calcium, which causes nerve damage.

“We wanted to find out if the theory that blocking sodium currents, which we developed in basic work over many years, actually served to protect neural tissue – a test-bed to see if we can achieve neuroprotection,” explains Dr. Kapoor.

30% less nerve damage with phenytoin

The team enrolled 86 individuals aged 18-60 with optic neuritis. The participants were randomized to receive either 4 mg/kg or 6 mg/kg of phenytoin or a placebo each day for 3 months.

At the end of the 3 months, all participants underwent optical coherence tomography (OCT), which measured the thickness of the retinal nerve fiber layer (RNFL) at the back of the eye.
Compared with participants who took the placebo, those who took phenytoin had around.

30% less damage to the RNFL.

Dr. Kapoor hails these findings as “promising,” noting that not only could phenytoin open the door to a new treatment for optical neuritis, but it could also lead to a new treatment for all nerve damage caused by MS.

Promising results from a clinical trial show more patients with advanced non-small-cell lung cancer could benefit from the immunotherapy drug pembrolizumab. In the trial, compared with chemotherapy, the immunotherapy drug improved survival in all patients whose tumors express a protein called PD-L1.

Results from the phase 2/3 trial – published in The Lancet – were presented at the first European Society for Medical Oncology (ESMO) Asia Congress in Singapore earlier this week.

An immunotherapy cancer drug works by getting the immune system to fight the cancer. Pembrolizumab (brand name Keytruda), is already approved by the Food and Drug Administration (FDA) for the treatment of certain categories of advanced non-small-cell lung cancer (NSCLC) and advanced melanoma.

Pembrolizumab is an antibody drug that targets a cellular pathway called PD-1/PD-L1. PD-1 is a receptor, and PD-L1 is one of the molecules that binds to it. The pathway is an example of what is called an immune checkpoint.

Many cancers are able to avoid attack from a patient’s immune system by overriding their “immune checkpoints” – molecules on immune cells that need to be activated or silenced to start an immune response.

By blocking the PD-1/PD-L1 pathway, pembrolizumab may boost the immune system’s ability to fight the cancer cells.

Pembrolizumab is shown to be effective against various types of cancer, including melanoma and lung cancer, where it has shown durable anti-tumor activity and acceptable toxicity in previously treated and untreated patients with advanced NSCLC.

The new trial is the first to assess the effectiveness of the immunotherapy drug as a second or later line treatment in advanced NSCLC patients positive for PD-L1.

The trial – called KEYNOTE-010 – tested two doses of pembrolizumab against the commonly used chemotherapy drug docetaxel in patients with tumors expressing PD-L1.

Controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains for FDA is ensuring that research participants are representative of the patients who will use the medical product.

Moving from the result of a clinical trial to applying it in practice is complex. But it’s generally agreed that the composition of the population enrolled in a trial should help FDA reviewers, clinicians, or policy makers to have confidence that the trial results will apply to future practice.

Furthermore, a wide range of people should have the opportunity to participate in trials, both for access to new therapies and to have the chance to contribute to better treatment of everyone, an important altruistic goal for many Americans.

Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. A substantial body of literature has documented this under-representation in recent years, particularly for women in some cardiovascular trials and general inclusion of black/African-American and minority participants in clinical trials. In response to these concerns, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action.

FDA has responded in multiple ways, including the creation of Drug Trials Snapshots that give the public readouts of the demographic profile of people participating in clinical trials for approved drugs. While progress has been made, we’ve learned from this program that we still have work to do. An evaluation of the Snapshots since the program began more than a year ago shows that some groups, especially ethnic and racial groups, aren’t always well represented in clinical trials.

These data are critical, because certain groups of patients may respond differently to therapies. For example, studies for a recently approved schizophrenia drug found that one side effect – the urge to move constantly – was seen more often in black/African-American patients. Two important classes of blood pressure drugs were found to work less well in black patients. And a drug for heart failure works very well in black patients but not in white patients. We also have seen labeling changes due to differences in dosing requirements between men and women, such as the recent labeling change with a sleep medication. These few examples show the importance of improving diversity in clinical trials, so medical products are safe and effective for everyone.

Increasing diversity in clinical trials is a priority for FDA. To that end, in 2016, the Agency is planning a variety of activities to push for greater inclusion, including more minority participation.