FDA Approves Azaya Therapeutics Investigational New Drug Application

Azaya Therapeutics, Inc. announced today that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product "ATI-1123," a novel and improved formulation of Taxotere® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

Azaya’s Phase I clinical study will now open for enrollment at two premier cancer research centers in Texas: South Texas Accelerated Research Therapeutics at the START Center for Cancer Care in San Antonio and The Mary Crowley Cancer Research Center in Dallas. Patients with solid tumors that have not responded to treatment with other anti-cancer agents will be enrolled in the study. The study is designed as an open-label, dose-escalation study that will determine the safety, tolerability and pharmacokinetics of the drug. The study also provides for the collection of efficacy data.

"The FDA’s acceptance of our IND package is an important milestone in the commercialization of this important and innovative new cancer treatment," said Michael T. Dwyer, president and CEO of Azaya. "Developing a cancer treatment such as ours takes an extraordinary amount of time and effort, and I am pleased to initiate our Phase I trial for patient enrollment," he added.

Azaya utilizes a proprietary manufacturing process to produce liposome-encapsulated chemotherapeutics that eliminates the use of toxic carriers and incorporates a naturally occurring protein to stabilize the liposomal encapsulated drug. Preclinical studies have demonstrated improvement in the toxicology profile and an enhanced efficacy of ATI-1123 compared to Taxotere® in a number of tumor models.

Azaya Therapeutics is a San Antonio-based emerging pharmaceutical company whose innovative technology platform makes safer and more effective cancer treatments. Its unique and proprietary Protein Stabilized Nanoparticle (PSN™) platform addresses the significant problems associated with delivery of water insoluble drugs. Azaya has leveraged this platform to develop differentiated drug products for the global oncology market. The company’s management is highly experienced in biotechnology and oncology and has a track record of obtaining FDA drug approvals and successfully building companies.

read more» Read more...

New Data from Phase III SATURN Study Showed Tarceva Improved Overall Survival When Used Immediately After Initial Chemotherapy in Patients with Advanc

OSI Pharmaceuticals, Inc. and Genentech, Inc. today announced that SATURN, a pivotal Phase III study of Tarceva® (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The new data will be presented during the 13th World Conference on Lung Cancer to be held July 31 to August 4, 2009 in San Francisco.

Treating patients immediately following first-line chemotherapy versus waiting for the cancer to grow or spread before giving additional treatment represents a new approach in advanced NSCLC.

“This study has now not only confirmed that immediate treatment with Tarceva after initial chemotherapy delayed the progression of disease, but also importantly helped patients in the study live longer,” said Professor Federico Cappuzzo, M.D., Istituto Clinico Humanitas IRCCS, Milan and principal investigator of the SATURN study. “This is good news for doctors and their patients since advanced lung cancer is one of the most challenging cancers to treat and is often associated with a very short life expectancy.”

The overall survival data will be submitted to the U.S. Food and Drug Administration (FDA) to support the supplemental New Drug Application (sNDA) for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC that was submitted on March 17, 2009. The FDA Prescription Drug User Fee Act (PDUFA) review date will be on or about January 18, 2010.

Additionally, Roche, OSI's international collaborator for Tarceva, will submit the overall survival data to the European Medicines Agency (EMEA) to support the application for use of Tarceva as a first-line maintenance treatment submitted in March 2009.

The U.S. and EU submissions were based on positive data from SATURN that were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) on May 31, 2009 in Orlando, Fla. SATURN met its primary endpoint and showed patients with advanced NSCLC who received Tarceva as a first-line maintenance treatment had a 41 percent improvement in the time they lived without the disease advancing (progression-free survival or PFS) compared to placebo (hazard ratio=0.71; 29 percent reduction in the risk of cancer progression or death). The safety results were consistent with what has been seen previously and there were no new or unexpected safety signals in the study. The most commonly reported adverse events in patients who received Tarceva were rash (49 percent, 213/438) and diarrhea (20 percent, 88/438).

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States. In 2009, approximately 159,000 Americans will die from the disease. Most people are diagnosed with advanced stage disease and only 15 percent survive five years.

Source : www.drugs.com

read more» Read more...

Strativa's New Drug Application For Ondansetron Orally Dissolving Film Strip Accepted By FDA

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ondansetron orally dissolving film strip (ODFS). Strativa is seeking approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

The ODFS, a new oral formulation of ondansetron designed to rapidly dissolve on the tongue, was developed using MonoSol Rx' proprietary PharmaFilm(TM) thin film technology. In clinical studies, this formulation demonstrated bioequivalence to ondansetron orally disintegrating tablets (ODT), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Strativa expects the FDA will complete its review or otherwise respond to the NDA by the first quarter of 2010.

"We are very pleased with the acceptance of our NDA submission and look forward to cooperating with the FDA on its review," said John A. MacPhee, President, Strativa Pharmaceuticals. "We believe the quick dissolving film strip formulation of ondansetron offers a convenient and easy-to-administer option for managing nausea and vomiting associated with chemotherapy, radiotherapy and surgery."

Nausea and vomiting is a common side effect associated with chemotherapy, radiation and surgery. Left untreated, nausea and vomiting can have serious consequences such as exhaustion, dehydration and undernourishment, which can interfere with treatment and healing.

In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to ondansetron orally dissolving film strip.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch.

About Par Pharmaceutical

Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

Safe Harbor Statement

Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.

Source : www.medicalnewstoday.com

read more» Read more...

Can the nausea and vomiting from chemotherapy be stopped? Yes it can!

When I was just out of medical school and in my first year of residency, I was assigned to the oncology service. One of the first patients I cared for had Hodgkin disease. Even then, we had pretty good treatment with a drug called nitrogen mustard. It worked well, but caused major nausea and vomiting.

Because of this, patients receiving the drug were admitted to the hospital and sedated while they received their infusion. I remember putting this man to sleep with intravenous seconal, and then giving the nitrogen mustard. He was hard to sedate and needed a lot of seconal. It took at least a day for him to wake up after he received the mustard. Still, it was better than retching for a day.
Later on, when I was working at a county hospital in Los Angeles, we were no longer admitting patients for chemotherapy but giving it to them in the outpatient area. We would give them a drug called compazine, which was next to useless. Another of my Hodgkin disease patients was receiving nitrogen mustard. His strategy was to jump on his motorcycle right after his infusion and race home before the retching began. If there was traffic, everyone suffered.

Then, as I have written earlier in this blog, patients began smoking marijuana, which helped some of them avoid nausea and vomiting from chemotherapy. These were mainly the younger patients. Older ones had trouble with the side effects. Getting high wasn’t a happy experience.

Finally, the drug companies came up with effective nausea-preventing drugs. These are the “trons”, like ondansetron, granisetron, etc. They blocked a certain body chemical called 5 HT and were very effective when they were given along with the chemotherapy. If we had them when my motorcycle guy was getting his drugs, he could ridden home at a much more leisurely pace.

But, by the next day, he might not have felt so well. It turns out that the “trons” are only good for the first day of chemotherapy, while the nausea and vomiting can persist for several days. Giving more of the “trons” doesn’t seem to help. One thing that can help is adding a steroid called dexamethasone to the drug mix on the first day. But still, for many the next few days can be tough.

Now the drug companies have come up with a new class of drugs to prevent nausea and vomiting. These can work for several days. They block another chemical called NK-1. All of these chemicals - 5HT, NK-1 - are made in the brain. It turns out that certain sites in the brain (not the stomach even though it feels like it) are the targets that chemotherapy drugs stimulate to cause nausea and vomiting.

I’m reminded of all this because of a paper published recently in the journal, Lancet Oncology. The researchers tested a new NK-1 blocking drug and found that only one of ten patients given major nausea-causing drugs got sick after their treatment, while one out of four patients who received a placebo developed nausea and vomiting. So we are getting close to almost total prevention of nausea and vomiting. One of these NK-1 drugs (aprepitant Emend) has been around for a couple of years, and now there is one more. We are almost there – no more nausea and vomiting from chemotherapy, and that is a very good thing.

One problem: These drugs cost – a lot – hundreds of dollars per treatment course. But if you ask anyone who has spent several days after their chemotherapy retching into their toilet, they will tell you it is worth it.

Source : www.1800blogger.com

read more» Read more...

Chemotherapy antidote may be lifesaving

In cancer patients accidentally overexposed with the chemotherapy drug 5-fluorouracil (5-FU), the drug vistonuridine (Wellstat Therapeutics Corp) may be lifesaving, according to research to be reported June 1 at the American Society of Clinical Oncology's annual meeting in Orlando.

The presentation at ASCO will report on 17 patients overdosed with 5-FU who received vistonuridine within 8 to 96 hours of overexposure. The drug was supplied under the US Food and Drug Administration's emergency-use Investigational New Drug provisions.

In a pre-meeting interview with Reuters Health, Michael Bamat, Wellstat's vice president for research and development, noted that all 17 of the vistonuridine-treated patients recovered fully. Without this antidote, at least 13 of these patients would have died, based on the dose of 5-FU they received.

"Vistonuridine performed very well and it also is, in itself, a very safe drug," Bamat said.

The National Institutes of Health estimates that 250,000 patients in the United States undergo 5-FU therapy annually and that 1,300 die from toxicities associated with 5-FU and another 8,000 have serious 5-FU-related toxicities.

5-FU overexposure can result from several factors, including infusion pump malfunction or misprogramming and dose calculation errors.

There is currently no approved antidote for 5-FU overexposure. "There really isn't much to do in these cases," Bamat said.

"Because no antidote for 5-FU overexposure is approved today, we have been responding to emergency requests for vistonuridine," Bamat said.

Vistonuridine was granted orphan drug status by the US FDA on May 1 and Wellstat is anticipating orphan drug status in Europe. The company plans to seek regulatory approval in the US and Europe.

Source : www.reuters.com

read more» Read more...

New drug reduces chemotherapy nausea

Phase III trial shows addition of new agent causes large reduction in nausea and vomiting after chemotherapy

Chemotherapy-induced nausea and vomiting (CINV) remains a clinical management problem after treatment with highly emetogenic chemotherapy (HEC)*.

A study has shown that the addition of a third drug (casopitant mesylate/CM) to a conventional two-drug regimen (dexamethasone and ondansetron) causes a big reduction in CINV events. The findings are reported in the June edition of The Lancet Oncology, written by Professor Steven Grunberg, University of Vermont, Burlington, VT, USA, and colleagues.
HEC is commonly used to treat many types of solid tumour cancers, eg, colorectral, pancreatic. Drugs such as dexamethasone and ondansetron are serotonin receptor antagonists and antiemetics, meaning that they block CINV through particular neurotransmitter receptor pathways . These drugs have been found to cause a big reduction in CINV events 0—24 h after chemotherapy, but during the ‘delayed’ phase (24-120 h post chemotherapy), they only provide moderate benefit. The authors say: “The delayed phase of CINV is not adequately managed.” CM antagonises the receptor of a molecule called NK1 (a different pathway), which earlier studies have shown to be effective in preventing the delayed phase of CINV.

This randomised phase III trial analysed 810 patients from 77 centres in 22 countries. All patients were receiving the dexamethasone and ondansetron combination post HEC. They were then randomised to also receive placebo (269 patients), a single 150 mg oral dose of CM (271), or 3-day intravenous plus oral CM (90 mg intravenous on day 1 plus 50 mg oral on days 2 and 3) (270). The primary endpoint was the proportion patients achieving complete response (no vomiting, retching or use of rescue medications) in the first 120 h after HEC.

The researchers found that 86% of patients in the single oral CM group and 80% of the intravenous plus oral CM group achieved a complete response for the first 120 h after their first cycle of HEC treatment, compared with just 66% of the placebo group. Adverse events related to CM use occurred in similar proportions in all three groups: placebo 11%, single oral dose group 10%, oral/intravenous group 12%.

The authors conclude: “A three-drug regimen including a single oral dose or 3-day intravenous plus oral regimen of casopitant mesylate plus dexamethasone and ondansetron significantly reduced CINV events in patients receiving HEC compared with a two-drug regimen of dexamethasone and ondansetron.”
They add: “Although convenience was not an endpoint in this trial, antiemetic regimens including a single dose of an NK-1 receptor antagonist might improve adherence and simplify antiemetic medication schedules for patients and caregivers.

“Further research is warranted to assess the efficacy of NK-1 receptor antagonists in other patient populations, such as patients with radiotherapy-induced nausea and vomiting (RINV), combined CINV and RINV, or those receiving other emetogenic chemotherapeutic agents (eg, oxaliplatin and irinotecan for colorectal cancer). These agents could also be explored in combination with other antiemetics (eg, palonosetron, olanzapine) that have been suggested to be effective against nausea.”


*highly emetogenic chemotherapy: chemotherapy that would cause CINV in almost all patients. (This is contrasted to moderately emetogenic chemotherapy, which would cause CINV in about half of the patients, or minimally emetogenic chemotherapy, which would cause CINV in very few patients).

Source : www.ecancermedicalscience.com

read more» Read more...