New Chronic Lymphocytic Leukemia Cancer Drug

FDA Approves Collaboration Drug After Extensive Clinical Trial Testing

Recently, pharmaceutical research companies AbbVie and Genentech cleared the clinical trial requirements set by the FDA to approve of their new drug to fight against chronic lymphocytic leukemia. The result of these two companies’ collaboration was the production of a newly approved drug, Venclexta. This approval makes Venclexta the first FDA-approved drug in a new class that combats BCL-2, a protein responsible for rapid cancer cell growth. By blocking the cancer cell boosted growth, the pill allows for the cell to age and die naturally.

About Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia is a subset of leukemia with a genetic abnormality making the leukemia more difficult to treat. Earlier this month, the FDA approved a new drug for those afflicted with chronic lymphocytic leukemia, specifically patients with a missing part of chromosome 17 who relapsed or who did not see improvement from an earlier treatment. This drug was the work of a collaboration effort from drug companies AbbVie and Genentech, with the pill labeled Venclexta.

Because chronic lymphocytic leukemia is incurable, relapsed patients must seek out a different drug after the prior one has failed. It is one of the most common type of leukemia found in adults, with about 15,000 newly reported annual cases in the U.S. alone.

Why The Venclexta Cancer Drug Works

Venclexta targets the “17p deletion” genetic abnormality. Patients who have relapsed or who have not seen improvement from previous treatments are more likely to have the abnormality, while those who have not undergone treatment at all make up to 10 percent of the chronic lymphocytic leukemia population.  Those with the 17p deletion abnormality have a life expectancy of 3 years or less, so this treatment offers an additional hope especially for those who have relapsed/not benefited from prior treatments.

In the clinical research trial, 106 chronic lymphocytic leukemia patients with the 17p deletion were tested. Following the trial, about 80% had their leukemia cancer gone into full or at least partial remission – those partial remission patients are still being monitored for any changes. The changes have benefited the patients ranging from a 3 month to a 19 month range.

AbbVie hopes that the FDA will approve Venclexta for different patient populations as well. It has been given further breakthrough designations in two more uses, therefore covering patients beyond those with the 17p deletion, but for patients with differing blood cancers as well. The other current breakthrough designations for Venclexta include one for acute myeloid leukemia for newly diagnosed patients unable to undergo chemotherapy, and another for relapsed chronic lymphocytic leukemia – without the 17p deletion, to be used alongside Rituxan (Roche’s blood cancer drug).

Moving Forward

The FDA approval of AbbVie/Genentech’s new leukemia drug is a huge step moving forward in the fight against cancer, as this drug will hopefully extend thousands, and even millions of lives for patients suffering from cancers like chronic lymphocytic leukemia. With that said, the reason for this step of progress was due to the countless hours of clinical testing used to show beyond a shadow of a doubt that this treatment can help people with this disease with little to no negative impact. As long as scientists continue to develop new ways to target these conditions, and people continue to sign up with patient recruitment clinical trials like these, we can continue to make strides towards ending cancer.

Psoriasis Drug Cleared by FDA

New Psoriasis Treatment Available After Successful Clinical Trials

Psoriasis is a chronic immune disease that affects around 7.5 million Americans alone, with 1 in 5 suffering from moderate-to-severe plaque psoriasis. Eli Lilly’s ixekizumab recently won FDA approval as a new treatment therapy for psoriasis.

Psoriasis Drug & the Clinical Research Trial

Last year in April, the autoimmune treatment met its main goals in a Phase III clinical research trial. The way the drug works is that ixekizumab, an antibody, blocks the interleukin-17A cytokine and thus lessens the autoimmune-caused inflammation.

Two doses were tested against the placebo in psoriatic arthritis patients, and both dosage groups each showed statistically significant results after the 24-week course. Ixekizumab also showed to beat out Amgen’s Enbrel in clearing plaque psoriasis. The study will continue to monitor ixekizumab’s long-term efficacy for 3 years.

Early this past February, Eli Lilly put in a request for approval through the European Medicines Agency, where they recommended it for approval, a process expected to take 3 months.

Alex Azar, president at Lilly USA, released in a statement, “many people living with plaque psoriasis are looking for another treatment option for this disease. With this FDA approval, we are proud to provide patients and dermatologists with a new choice that may provide significant improvement of psoriasis plaques.”

Next Steps for Eli Lilly

Following the FDA approval for Novartis’ Cosentyx drug, Lilly will continue to expand the psoriasis treatment market. Cosentyx received two additional approvals for its use in psoriatic arthritis and ankylosing spondylitis just this past January, and ixekizumab, to be sold with the marketed name Taltz, seems likely to obtain approval for psoriatic arthritis in the upcoming year as well.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment options to help relieve the skin irritation and discomfort from the condition,” said Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Stay Up to Date on Clinical Trial News

FDA approvals like the one discussed above are always done conservatively, and after extensive testing and clinical trials have been taken into consideration. Therefore, having Novartis’ treatment obtain FDA approval is a significant deal. To stay up to date on the latest news from clinical trials like this one as well as local clinical research trials, sign up for our newsletter today.



Ovarian Cancer Drug Fast Tracked for Clinical Research Trial

Promising Results After Successful Patient Enrollment In Clinical Trial

A new treatment for platinum-resistant ovarian cancer has been granted Fast Track status to the CA4P drug, developed by OXiGENE, Inc. Fast Track designation opens up wider access and communications with the FDA, and can later shorten the standard FDA review timeline from 10 to 6 months by allowing the drug to be submitted for priority review of the New Drug Application.

CA4P (combretastatin-A4 phosphate or fosbretabulin) is a vascular disrupting agent (VDA) that targets existing tumor blood vessels. By quickly binding to the tumor blood vessels, the tumors become compromised due to ischemia (insufficient blood flow) and necrosis (tissue death). Cancer cell death then occurs in the central region of the tumor. When used alone, CA4P has shown that tumor regrowth may appear after the treatment course. So, OXiGENE has focused on a combination therapy, combining CA4P with bevacizumab.

CA4P’s Phase II Clinical Trial

In a randomized controlled Phase II trial, CA4P showed to improve response rates and progression-free survival in patients with recurrent ovarian cancer. By combining CA4P with bevacizumab, an existing combination anti-vascular therapy drug, these results showed to be especially evident in patients with platinum-resistant ovarian cancer.

Regarding the Fast Track status, William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE, stated, “The FDA’s granting of Fast Track status to CA4P is a significant acknowledgement of the potential for CA4P to provide a new and better treatment option for women with platinum-resistant ovarian cancer. I am pleased that we now have the opportunity to work closely with FDA to expedite our CA4P development program in ovarian cancer, as we seek to bring this promising product candidate to patients.”

This April or May will see a new Phase II/III study with 436 enrolled subjects. The primary endpoint is a progression-free survival for over at least 12 months, with the study completion date to be estimated for July 2018.

Next Steps: Patient Enrollment

This new clinical trial is huge news in the fight against ovarian cancer. With that said, in order to see whether or not this fast track status will ultimately lead to an FDA approval, OXiGENE will need to yield positive results from their phase II/III clinical trials; and in order to accomplish this, they will need to obtain a significant sample size from patient enrollment and people willing to participate in clinical research trials. Only time will tell if CA4P can provide a better treatment option for women with platinum-resistant ovarian cancer, and we will continue to monitor this case as it progresses.

Psoriasis Treatment Finishes PoC Clinical Trial Testing

Psoriasis Drug Will Undergo Further Research Trials To Test Effectiveness

After completing a proof-of-concept (PoC) clinical trial, Vitae Pharmaceutical’s psoriasis drug proved to show its efficacy worth through the reduction of psoriasis severity. As a result, it will be designated the opportunity to undergo further clinical research trials.

About The Psoriasis Drug

The drug itself is referred to as VTP-43742. Unlike most psoriasis drugs in the market, VTP-43742 finds itself as an oral therapy in an otherwise injectable treatment-market, with Novartis’ Cosentyx leading the pack.

Jeff Hatfield, Vitae Pharmaceutical’s CEO, said “we believe VTP-43742 has the potential to expand utilization of oral therapy in a variety of autoimmune disorders, such as psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease with an effective, safe and well tolerated, once-a-day agent.”

The current treatments for psoriasis inflammation come in the form of injections. Novartis’ Cosentyx blocks the activity of interleukin017 (IL-17), an inflammatory protein, which clears up psoriasis and psoriatic arthritis. VTP-43742 goes straight to the protein RORyt that secretes IL-17 and prevents it from carrying out such activity. In addition to this preventative measure, the company believes that the oral tablet will prove to be a highly marketable and effective alternative to injections.

The Clinical Research Trial Findings

While the 4 week initial trial did not show strong evidence of a statistical significance over the placebo, the company highlighted the fact that psoriasis therapies average around a 12-weeks of treatment in order to come about with hard evidence. In the meantime, Vitae Pharmaceuticals asserts the drug’s worth that the 4 week concept trial gives cause for a fully executed longer clinical trial. A 16 week study will begin during the second half of 2016.

The trial’s safety results showed no abnormalities – there were no serious side effects and the enzyme elevation changes in four patients were reversible. The oral drug was tolerated at 350 mg and 700 mg a day without any related cardiac abnormalities. Although a third higher dosage was planned, the minimal enzyme spikes gave cause for Vitae to decide against it.

The Next Steps: Patient Recruitment

So while Vitae Pharmaceutical’s Psoriasis drug managed to pass the PoC stage, this is just one of the very first steps in approving this new treatment. The PoC stage helps in linking between Phase-I and Phase-II dose ranging clinical research trials. What is needed from here is a larger sample of data, and therefore a larger number of patients willing to undergo such a study. If you or anyone you know is interested in learning more about registering for a clinical research trial like this one, sign up to be a patient with Clinical Trial Spotlight. Our vast pool of resources helps connect patients to clinical research trials all around the country. Together, we can advance the cause and fight these terrible diseases and conditions. Contact us if you have any further questions about clinical trials or signing up. Let’s end these plights together!

Positive Clinical Trial Results Allow FDA To Approve New HIV Treatment

Single Pill Combination Drug to Treat HIV Type-1

Gilead Sciences announced early this March that the U.S. Food and Drug Administration has approved Odefsey for treating HIV-1 infections. Odefsey, a single tablet, is a combination drug made up of emtricitabine, rilpivirine, and tenofovir aladfenamide (TAF). It has been approved to treat HIV type-1, the most common form of HIV.

In November of last year, Genvoya, another Gilead drug treating HIV, was the first drug containing TAF to receive FDA approval. Odefsey, now the second FDA-approved TAF drug, is now the smallest single tablet regimen HIV treatment on the market.

How the TAF HIV Treatment Works

TAF presents a high antiviral efficacy similar to and requiring less than 1/10th than that of Viread, Gilead’s HIV TDF treatment. TAF data has shown that it can enter cells, namely HIV-infected cells, at a more effect rate than TDF, therefore requiring a lower dose. TAF has shown to also have fewer side effects than TDF.

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

Following the approval of Genvoya, and now Odefsey, Gilead Sciences is working on obtaining FDA approval for the HIV-1 drug Descovy (emtricitabine+TAF), which had been EMA-recommended for EU approval a week prior to Odefsey.

Odefsey Requirements for Potential HIV Patients

Gilead Sciences has taken into consideration that the younger an HIV patient is, the higher risk they are for the development of age- and treatment-related diseases, for the early combination of HIV infection, antiretroviral treatments and the natural aging process weakens bone mineral density and causes renal impairment. Odefsey is a complete regimen for patients starting at the age of 12 years who have not yet received antiretroviral treatment and have HIV-1 RNA levels less than or equal to 100,00 copies per mL.

Odefsey can also serve as a replacement for a stable antiretroviral regimen in patients with HIV-1 RNA less than 50 copies per mL (virologically-suppressed) for at least 6 months, with the same requirement of not having had a history of failed treatments.

Enroll As a Patient in to Help Advance Clinical Research Trials

The FDA-approved HIV drug Odefsey brings about another success for Gilead Sciences’ TAF-based infections. While neither Odefsey, nor does any currently marketed drug, cure HIV infection or AIDS, this new drug regimen allows for a longer term of managing HIV treatments. Such advancements in clinical research are only made possible by the combination of both researchers’ and patients’ efforts. FDA approval is only gained after the drug has been tested in clinical research trials. Therefore, if you would like to help make a difference in research trials just like this, sign up and enroll as a patient.  We thank you for your participation to make a difference.

Follicular Lymphoma Drug Approved by the FDA

Trial Results Show Significant Results Thereby Obtaining FDA Approval

Genentech announced the FDA approval for their anti-CD20 agent drug, Gazyva (obinutuzumab), for follicular lymphoma patients who relapsed after, or are refractory to, a rituximab-containing regimen. This FDA approval was given after significant results were shown during the phase III clinical research trial for their Gazyva drug.

Sandra Horning, MD, Genentech’s CMO and head of Global Product Development stated, “people with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back.”

The FDA also approved of obinutuzumab for use in combination with chlorambucil as a first-line primary treatment for chronic lymphocytic leukemia patients.

The Phase III GADOLIN Clinical Research Trial

It was due to GADOLIN’s study results which allowed for the FDA approval. Obinutuzumab and bendamustine followed by obinutuzumab monotherapy showed to reduce the disease progression by 52% when compared to follicular lymphoma patients who received bendamustine treatment alone.

413 patients with rituximab-refractor indolent non-Hodgkin lymphoma (of which the most common being follicular lymphoma, 321 patients) were studied in the multicenter, open-label GADOLIN trial. Rituximab-refractory classified patients meant that they did not show progression from rituximab monotherapy or rituximab + chemotherapy, or had shown a relapse within 6 months of the last rituximab-based (monotherapy or the combo chemotherapy) dose.

“Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death,” said Horning.

Details of the GADOLIN Clinical Research Trial

During the clinical research trial, the median patient age was 63 years, about 4 months had passed since their last therapy, and more than 90% of the patients were refractory, had no response, to their last treatment.

Group 1 (experimental arm) received bendamustine and obinutuzumab treatments every 2 months for 2 years. Group 2 (comparator group) received bendamustine monotherapy treatments.

Group 1’s progression-free survival (PFS), the primary endpoint measure, had a median of 29.2 months compared to Group 2’s 13.7 months. At 24.1 months, death risk had reduced by 38% through Group 1’s obinutuzumab regimen compared to Group 2’s monotherapy.

Enroll As a Patient for Future Clinical Trials

Genentech proudly shared their new FDA approval status for follicular lymphoma late February, following their GADOLIN clinical research trial. Such advancements in clinical research are only made possible by the combination of both researchers’ and patients’ efforts. Without the volunteers from the non-Hodgekin lymphoma’s patient population, these critical results would not have been as impactful. Therefore, if you would like to help make a difference in research trials just like this, sign up and enroll as a patient.  Let’s fight the good fight together.

Positive Results from AML Clinical Research Trial – Midostaurin

Trial Results Pave Way for Breakthrough Therapy Drug Designation Status

Following the Phase III RATIFY clinical trial, Novartis received the Breakthrough Therapy drug designation for the acute myeloid leukemia drug, midostaurin.

The Breakthrough Therapy drug designation allows for the expedition of drug development and review for medicines that treat serious or life-threatening conditions. The drug must have demonstrated quantitative improvement over a current available therapy on at least one clinically determined endpoint. In this case, the compound PKC412 (midostaurin) was compared to the current standard of AML chemotherapy drugs, daunorubicin and cytarabine, with a clinical emphasis on AML cases with a mutated FLT3 gene.

The Phase III RATFIY Clinical Trial

Patients with newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) were enrolled in order to test the investigational compound PKC412, midostaurin. The overall purpose of the clinical research trial was to evaluate the midostaurin or placebo to daunorubicin/cytarabine, the current standard chemotherapy drugs for AML induction.

Patients receiving midostaurin then standard induction and consolidation chemotherapy were compared to those who received only standard induction and consolidation chemotherapy. Overall survival (OS) for patients in the midostaurin treatment group was 74.7 months, while those in the placebo group had an OS of 25.6 months, with no treatment-related deaths observed.

Current AML Treatment

For more than 25 years, acute myeloid leukemia treatment has not seen any progressive changes. 21,000 people in the U.S. are diagnosed with AML each year, with about a third who have an FLT3 gene mutation. This gene mutation has been seen to have worse outcomes and a shorter survival rate in those without the mutation.

Midostaurin is the first drug to show an increase in survival rates with a specific target in the FLT3 gene, a malignancy without any current FDA-approved treatments.

Because midostaurin is expected to be submitted for FDA approval, Novartis has opened a Global Individual Patient Program which will allow approved patients 18 years of age or older with newly-diagnosed FLT3-mutated AML to be considered for midostaurin therapy. Novartis has announced a collaboration with Invivoscribe Technologies, Inc. in order to identify potential patients that meet the requirements of having an FLT3 mutation and with the probability of benefitting from midostaurin treatment.

Hurdles for AML Treatment

About a third of the AML patient population has the hematologic malignancy FLT3 gene mutation. As of yet, an FDA-approved method of targeted treatment has not been found. However, the clinical research trial RATIFY showed to have a significant positive effect on patients with the FLT3 mutated gene, allowing for the FDA to grant midostaurin the Breakthrough Therapy designation. In the future, with a greater sample size research trial, midostaurin could potentially reshape the way we see AML treatment.

Enroll As a Patient For Future Clinical Trials

As stated above, there have not been any significant developments in AML treatment for two and a half decades. The reason we are able to make breakthroughs now is because of patients enrolling in these clinical research trials and helping to improve our knowledge of this condition and how it reacts to trial drugs. Therefore, if you would like to help make a difference in research trials just like this, sign up and enroll as a patient.  We can make a difference. We just need to do it together.