Tuesday, December 17, 2013

Check out new content on www.HelpWithCancer.org

I want to apologize for not posting here at Cancer News for two months.  Despite my inactivity here, lots has happened in the world of cancer therapy and research.

I'm a busy guy these days.  I just returned from New Orleans, where I covered the annual American Society of Hematology (ASH) meetings on behalf of the International Myeloma Foundation (IMF).  I'm now busy sorting through hundreds of abstracts and writing about what I heard and saw in the massive convention center on the banks of the Mississippi River.

My wife helps me organize and manage four different cancer related websites: www.HelpWithCancer.org, www.MultipleMyelomaBlog.com, www.MyelomaNews.com and this site, CancerNews.US.  But even with Pattie's help, I'm having trouble keeping up. 

To be honest, I'm facing some health related challenges these days, too.  My bone marrow cancer (multiple myeloma) has relapsed for the third time.  Between undergoing therapy, seeing specialists, driving to and from appointments and sitting in waiting rooms, I spend up to 15 hours a week dealing with my own health care.

So I've made a difficult decision.  This site has never been a priority.  A great idea, but not unlike someone who bellies up to a buffet only to learn that his eyes were bigger than his stomach.  I simply don't have time to do CancerNews.US justice.

So I've decided to focus on our five year old www.HelpWithCancer.org site instead.  Primarily focused on healthy living tips and how best to use anticancer supplements, I will try and include more general cancer related news on HWC now--the type of things I would have covered here.

I want to wish all of our readers my best.  Good luck to all of you with your cancer journey!

Feel good and keep smiling!  Pat

Monday, September 30, 2013

Old drugs bring new hope to lung cancer patients

Yes, I wish researchers could develop new classes of anti-cancer drugs.  But going back and finding new uses for existing medications saves everyone a lot of money.  Check this out:

Could Antidepressant Combat Lethal Lung Cancer?

Little-used depression drug shows early promise in lab, mice studies

September 27, 2013

FRIDAY, Sept. 27 (HealthDay News) -- An older and little-used class of antidepressants may help combat a particularly deadly form of lung cancer, according to a new study.

Using a unique computer program, researchers from the Stanford University School of Medicine identified tricyclic antidepressants as a potential treatment for small cell lung cancer. This class of drugs was introduced decades ago and is still approved for use in the United States, but has been supplanted by newer antidepressants with fewer side effects.

Follow-up experiments showed that the tricyclic antidepressant called imipramine (Tofranil), was effective against human small cell lung cancer cells grown in the laboratory and growing as tumors in mice. The drug activated a self-destruction pathway in the cancer cells and slowed or blocked the spread of cancer in mice.
Imipramine maintained its effectiveness regardless of whether the cancer cells had previously been exposed, and become resistant, to traditional chemotherapy treatments, according to the study, which was published online Sept. 27 in the journal Cancer Discovery.

Because tricyclic antidepressants already have U.S. Food and Drug Administration approval for use in people, the Stanford team was quickly able to launch a clinical trial to test imipramine in patients with small cell lung cancer and certain other types of cancer. They are currently recruiting patients for the phase-2 trial.
"We are cutting down the decade or more and the $1 billion it can typically take to translate a laboratory finding into a successful drug treatment to about one to two years and spending about $100,000," study co-senior author Dr. Atul Butte, director of the Center for Pediatric Bioinformatics at Lucile Packard Children's Hospital at Stanford, said in a university news release.

"The five-year survival for small cell lung cancer is only 5 percent," study co-senior author Julien Sage, an associate professor of pediatrics, said in the news release. "There has not been a single efficient therapy developed in the last 30 years. But when we began to test these drugs in human cancer cells grown in a dish and in a mouse model, they worked, and they worked, and they worked."

Another drug, an antihistamine called promethazine (Phenergan), also exhibited the ability to kill cancer cells, according to the researchers.

More information
The U.S. National Cancer Institute has more about small cell lung cancer.
Copyright © 2012 HealthDay. All rights reserved.

Monday, September 9, 2013

Celgene's breast cancer drug approved for pancreatic cancer now, too

How tough is pancreatic cancer to treat?  FDA approval of existing cancer drug, Abraxane, based on anemic overall survival (OS) stat improvement of a meager 1.8 months.  Here's a short article about it, courtesy of HealthDay News:

Abraxane Approved for Late-Stage Pancreatic Cancer


Previously sanctioned for cancers of the lung and breast


FRIDAY, Sept. 6 (HealthDay News) -- U.S. Food and Drug Administration approval for Abraxane (paclitaxel) has been expanded to include advanced pancreatic cancer, the agency said Friday in a news release.

The agency previously approved the chemotherapy drug to treat cancers of the lung and breast.
Some 45,220 people are expected to be diagnosed with pancreatic cancer this year, and an estimated 38,460 will die from it, the FDA said.

Pancreatic cancer is the fourth-leading cause of cancer death. Surgery is the only way to permanently remove pancreatic cancer, but it's usually too late for surgery by the time most cases are identified, the agency said.

Abraxane's safety and effectiveness in treating pancreatic cancer were evaluated in clinical trials involving 861 people. Those treated with Abraxane and another chemotherapy drug, gemcitabine, lived an average of 1.8 months longer than those treated with gemcitabine alone.

Common side effects of the drug combination included a drop in white blood cells and blood platelets, fatigue, nerve damage in the extremities, vomiting, diarrhea and fever.
Abraxane is marketed by Celgene, based in Summit, N.J.

1.8 months?  Hard to say if I would endure side effects like those for such a short return on my quality of life "investment."

I have an acquaintance battling pancreatic cancer now. Doing better than Mayo Clinic docs expected.  Original six month prognosis may turn into a year or more.  Not sure if he is using this drug as part of his ongoing chemotherapy regimen...

Tough stuff!  Feel good and keep smiling!  Pat

Thursday, September 5, 2013

Valerie Harper Cancer Update

I watched Valerie Harper last night on "Hot in Cleveland."  Sort of a Mary Tyler Moore TV show reunion. 

Here's an update on her progress fighting terminal brain cancer.  Sounds like she's doing pretty well!

Valerie Harper's Terminal Brain Cancer "Pretty Close to a Remission," Says Her Doctor—Watch Now

by Rebecca Macatee Thu., Aug. 29, 2013

Valerie Harper went public with her terminal brain cancer diagnosis in March 2013, but five months later, things are looking hopeful for the beloved Mary Tyler Moore star.

In fact, according to her doctor, the 74-year-old actress is "getting pretty close to remission." But, as Dr. Jeremy Rudnick explained in an interview excerpted on Today, Thursday, Aug. 29,  the rare form of cancer will still be fatal.

"It defies the odds," he explained of Valerie's response to chemotherapy as well as alternative treatments like acupuncture, but he explained that her leptomeningeal carcinomatosis will "develop resistance to the therapy." Meaning? "It's not a matter of if (the cancer becomes resistant)," said Dr. Rudnick, "it's a matter of when."

NEWS: Valerie Harper begins work on TV movie

"Going from having three months to live, or less; we're into our sixth month, and now there's even hope beyond right now we're looking at—" he started.

And Harper interjected cheerily, "We're looking at Christmas!"

"Life is about buying time," her physician said.

Harper agreed, saying "Exactly…That's what I always say."

Lots of great video; go to:

http://www.eonline.com/news/453583/valerie-harper-s-terminal-brain-cancer-pretty-close-to-a-remission-says-her-doctor-watch-now

We wish her all the best.  Feel good and keep smiling!  Pat

Thursday, August 8, 2013

Onyx Pharmaceutical 2nd Quarter Financials:

NO LINK AVAILABLE

Onyx Pharmaceuticals Reports Second Quarter 2013 Financial Results

Total Revenue More Than Doubles to $153 Million vs. Prior Year

SOUTH SAN FRANCISCO, CA--(Marketwired - August 08, 2013) - Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the second quarter 2013 and provided a business update on Kyprolis® (carfilzomib) for Injection, Nexavar® (sorafenib) tablets and Stivarga® (regorafenib) tablets.

"Accelerating revenue from each of our products, coupled with strategic investment to unlock the value of Kyprolis, provides a compelling platform for the current and future growth of Onyx," said Tony Coles, M.D., chairman and chief executive officer of Onyx. "With our Phase 3 program for Kyprolis across all lines of multiple myeloma therapy, we are committed to expanding the label globally, and we have a clear strategy to enable a filing in Europe in the second half of 2014, pending positive results from both ASPIRE and FOCUS. Important commercial, clinical, and regulatory momentum across the business continues to drive Onyx's value creation as we become an emerging global oncology leader."

For the second quarter of 2013, Onyx reported total revenue of $153.0 million and a non-GAAP net loss of $29.0 million, or $0.40 per diluted share. On a GAAP basis, Onyx reported a net loss of $53.2 million, or $0.73 per diluted share, for the second quarter 2013. A description of the non-GAAP calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."

Revenue
Total revenue of $153.0 million for the second quarter of 2013 represented a 110% increase from total revenue of $72.7 million for the comparable period in 2012.
  • Revenue from the Nexavar collaboration agreement with Bayer for the second quarter of 2013 was $81.8 million as compared to $72.7 million for the comparable period in 2012. The increase in revenue from collaboration was primarily due to sales growth in the United States and Asia Pacific regions as well as lower expenses.
  • Kyprolis net sales for the second quarter of 2013 were $61.0 million, representing orders shipped to and received by customers such as physician offices and hospitals. In addition, Onyx recorded deferred revenue of $10.0 million as of June 30, 2013, representing Kyprolis inventory at distributors which had not yet shipped to physician offices and hospitals.
  • Stivarga royalty revenue was $10.2 million for the second quarter of 2013. Onyx receives a 20% royalty on global net sales of Stivarga in jurisdictions that have received commercial marketing approval. Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States.
Operating Expenses
Non-GAAP cost of goods sold was $1.8 million for the second quarter of 2013. Cost of goods sold related to sales of Kyprolis is not representative of Onyx's future expectations of cost of goods sold because certain product costs associated with Kyprolis sales in the second quarter of 2013 were charged to research and development expense in periods prior to approval on July 20, 2012. On a GAAP basis, cost of goods sold was $2.0 million for the second quarter of 2013.

Non-GAAP research and development expense was $99.4 million for the second quarter of 2013, compared to $73.6 million for the same period in 2012. Higher research and development expense between periods was primarily due to the global development of Kyprolis, particularly the ongoing Phase 3 ENDEAVOR trial, and start-up activities associated with the front-line CLARION study, as well as oprozomib development expense, which were partially offset by lower Kyprolis Phase 3 FOCUS and ASPIRE trial expense. On a GAAP basis, research and development expense was $102.8 million for the second quarter of 2013, compared to $76.4 million for the same period in 2012.

Non-GAAP selling, general and administrative expense was $78.4 million for the second quarter of 2013, compared to $40.7 million for the same period in 2012. Higher selling, general and administrative expense between periods was primarily related to the increased headcount following the hiring of the field sales force associated with the commercial launch of Kyprolis in the United States and adding select capabilities internationally. On a GAAP basis, selling, general and administrative expense was $87.5 million for the second quarter of 2013, compared to $48.9 million for the same period in 2012.

Onyx recorded amortization expense of $5.2 million for the second quarter of 2013, which reflected the amortization of its finite-lived intangible asset, which was acquired in the 2009 acquisition of Proteolix, Inc.

Cash, Cash Equivalents and Marketable Securities
On June 30, 2013, cash, cash equivalents and current and non-current marketable securities were $755.9 million, compared to $492.8 million at December 31, 2012. The increase was primarily due to net proceeds of approximately $352 million received from a public offering of 4.4 million shares of common stock, completed in January 2013, offset primarily by net operating expenses.

Six-Month Results
Total revenue was $298.5 million and $144.7 million for the six months ended June 30, 2013 and 2012, respectively. Revenue from the Nexavar collaboration agreement with Bayer was $152.1 million and $144.7 million for the six months ended June 30, 2013 and 2012, respectively. Kyprolis net sales were $125.0 million for the six months ended June 30, 2013. Stivarga royalty revenue was $19.3 million for the six months ended June 30, 2013. Non-GAAP net loss for the six months ended June 30, 2013 was $42.8 million or $0.59 per diluted share, compared to $87.1 million, or $1.36 per diluted share for the same period in 2012. For the six months ended June 30, 2013, on a GAAP basis Onyx recorded a net loss of $86.8 million, or $1.20 per diluted share, compared with a net loss of $162.3 million, or $2.54 per diluted share, for the same period in 2012.

Non-GAAP Financial Measures
This press release and the reconciliation table included herein includes the following non-GAAP financial measures: non-GAAP net income (loss), non-GAAP net income (loss) - diluted, non-GAAP net income (loss) per share, non-GAAP net income (loss) per share - diluted, non-GAAP cost of goods sold, non-GAAP research and development expense, non-GAAP selling, general and administrative expense and non-GAAP operating expenses. A description of the non-GAAP calculations and reconciliation to the comparable GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."

Onyx management uses these non-GAAP financial measures to monitor and evaluate our operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. Onyx management believes the non-GAAP information is useful for investors by offering the ability to better identify trends in our business and better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all items of income and expense that affect Onyx. These non-GAAP financial measures are not prepared in accordance with, and should not be considered in isolation of, or as an alternative to, measurements required by GAAP.

Management Conference Call Today
Onyx will host a webcast and conference call with management to discuss second quarter 2013 financial results, as well as provide a general business overview, today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).
To access a live audio webcast of the conference call, log onto the Company's website at: http://www.onyx.com/investors/event-calendar
To access the live conference call, dial 847-585-4405 and use the passcode 35393849#. A replay of the call will be available on the Onyx website, or by dialing 630-652-3042 and using the passcode 35393849# beginning approximately one hour after the teleconference concludes through August 22, 2013.

About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The Company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the Company's website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.