Cancer Clinical Trials and Treatments Late Stage Developments

Image via WikipediaFrom FierceBiotech

For the cancer drug research enthusiast, this report might read in places like a special oncology edition of a gun magazine. Indeed, there are plenty of weapons against cancer to read about here. Several of the drugs listed here represent the advancement of relatively new methods of attacking cancer, including "armed antibodies" and cancer-killing viruses.

 In addition, decades of basic research into the molecular drivers of cancer growth are bearing fruit for drug developers. Not only are these companies making progress in clinical trials, they have landed buyout deals and lucrative partnerships. It's also clear that relatively small companies like Aveo Pharmaceuticals and Curis are making inroads along side the big boys like Pfizer and Roche.

There are 10 late-stage drugs listed in this report, but this editor hesitates to call them the "Top 10" only because there are so many variables to consider to rank them in such a way objectively. Yet these 10 drugs have certainly been generating news and, in most cases, lots of interest among investors and the medical community. All of the drugs have reached pivotal trials for at least one type of cancer.
Here's the list in alphabetical order by each drug's most commonly used moniker, whether that is its alphanumeric code name or generic name. As always, please let us know whether you think there are cancer drugs in pivotal trials that you think should have been on this list or ones on this list that shouldn't be.

1. Carfilzomib - multiple myeloma
2. Crizotinib (PF-02341066) - lung cancer
3. GDC-0449 (vismodegib) - basal cell carcinoma
4. OncoVex - advanced melanoma
5. PLX4032 (RG7204) - melanoma
6. Ponatinib - leukemia
7. SGN-35 (brentuximab vedotin) - Hodgkin's lymphoma, anaplastic large cell lymphomas
8. Tivozanib (AV-951) - advanced renal cell carcinoma
9. T-DM1 (Trastuzumab-DM1) - breast cancer
10. XL184 (cabozantinib) -  prostate cancer

Pfizer's To Present Lung Cancer Data July 3-7

Image via CrunchBase Pfizer Inc. will present early and mid-stage data from its lung cancer portfolio, including PF-00299804 (PF-299) an investigational, oral, pan-HER inhibitor;¹ and crizotinib, an investigational, oral, first-in-class compound that inhibits the anaplastic lymphoma kinase, or ALK,² at the International Association for the Study of Lung Cancer’s (IASLC) 14^th World Conference on Lung Cancer (WCLC), July 3-7 in Amsterdam, The Netherlands.

“While lung cancer remains a difficult-to-treat disease, we’re learning more about how therapies like crizotinib and PF-299 may be able to specifically target ALK or the HER pathway, respectively, and how this may lead to more rationally selected and personalized therapy,” said Maurizio Voi, MD, Thoracic Tumor Strategy Lead, Pfizer Oncology. “Data being presented show survival outcomes for PF-299 and crizotinib, as well as quality-of-life or patient-reported outcomes after treatment for patients with non small cell lung cancer, which represent important considerations in determining the best treatment option for these patients.”

First Presentation of PF-299 Preliminary Overall Survival Data

Continued....

Bristol melanoma drug extends survival in study

By Bill Berkrot

NEW YORK | Mon Mar 21, 2011 6:37pm EDT

(Reuters) - Bristol-Myers Squibb Co's eagerly anticipated experimental drug ipilimumab extended survival of previously untreated patients with advanced melanoma in a late stage study, the company said.

Details of how much longer patients who were suffering from the deadly skin cancer lived after taking the highly promising Bristol drug will be unveiled at a major medical meeting in June.

Bristol-Myers shares were up 4.3 percent at $27.10 in extended trading from their New York Stock Exchange close at $26. They initially jumped 5.7 percent after news of the clinical trial's success was reported.

Extending overall survival -- the primary goal of the study -- is considered the gold standard for cancer drug trials.

U.S. health regulators are expected to approve ipilimumab this week based on results of a different study of patients who had received prior treatment for advanced melanoma.  In that study the Bristol-Myers drug extended survival by an average of four months, which was seen as a major advance for a disease littered with drug failures and for which there are really no effective treatment options.

The Food and Drug Administration in November delayed its approval decision to give it more time to review data on the medicine, setting a new action date of March 26. "Ipilimumab is an exciting drug, especially given the dearth of effective therapies for this bad form of cancer," Sanford Bernstein analyst Tim Anderson said in a research note.Advanced melanoma is one of the deadliest cancers and can quickly spread from the skin to internal organs, such as the brain. Once melanoma spreads to other organs the average survival is typically only six to nine months.

This Week's Watchlist Oct 25 2010 With the FDA

Image via Wikipedia

A, B and Z DNA Structures, the building blocks of Proteins and Amino Acids

Today's Theme For Pictures Today

 On tap for this week we have three FDA decisions:

ARNA - Arena received an expected CRL on Saturday for its weightloss drug Lorcaserin. (Subscribers to BioRunUp were immediately notified via SMS and email alerts) The CRL was as expected with no real surprises. It will be interesting to see how the market reacts to the FDA's requests on Monday morning. ARNA closed at $1.63 on Friday after surging nearly 22% at one point during the day. These prices are much below its run-up high of $8 in late July.  Arena Receives CRL

BIOD - Biodel is up for an FDA decision on 10/30/10, and trader consensus is clearly leaning towards a CRL from the FDA. Traders became even more jittery last week as the FDA delivered some heavy handed CRLs to AMLN/ALKS, on a drug that was widely expected to receive approval. The market seemed to react as if saying 'If AMLN/ALKS was 'in the bag' and the FDA required more trials, there is NO way that the FDA will approve Linjeta with that botch India data.' Trading at under a 100M market cap, BIOD has incredible potential on approval. However FDA uncertainty seems to have limited the run-up.

AVNR - Out of this week's watchlist stocks, AVNR seems to have the best odds of approval. Despite this, AVNR still took a hit from the AMLN/ALKS CRL. This was because that CRL was based largely because the FDA was concerned about prolongation of QT interval, a concern that was also expressed by the FDA in Avanir’s first CRL for AVP-923. Will this continue to haunt AVNR? We will soon find out.

EXAS - Its catalyst time for one of our best picks of the year. We recommended EXAS in the high $3 range and were thrilled to watch it climb to over $9. Study results are going to be presented this Friday, 10/29 at the AACR conference.  
 
BioPharma Investor's Decisions:
 
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Exact Sciences Anticipating Oct. 29th Results

Image by Christiana Care via Flickr Exact Sciences has been on fire lately.  I do think that the stock will dilute in the next few weeks but I could be wrong.  They will need to recoup some of their capital from their clinical trials debt that they have accrued.  Exact Sciences is a very explosive stock that could really go higher than expected.  Who Knows?  I really like the options for Exact Sciences growth in 2011 and beyond.  In 3 Months Exact has gone from  3.46 to 8.88, a gain of 158.89%.    I expect it to drop down a bit and would suggest any future purchase of shares to come down a bit with a Limit Order.  Buy Exact at  some form discount at these very hyped up increased levels.  But they might not come down and you should buy some at the current Market Price. 

Wikinvest---Exact Sciences (EXAS)

Google Finance--Exact Sciences (EXAS)


Biotech Stock Mailbag: Exact Sciences

BOSTON (TheStreet) -- Did you catch Jim Cramer's excellent Mad Money segment Wednesday on Exact Sciences(EXAS_)?

If not, a question from Paul P. on the colon cancer diagnostic stock kicks off this week's Biotech Stock Mailbag: "Have you followed and/or have any thoughts on Exact Sciences? I've been following it and am hearing that it may be overhyped. Your thoughts would be appreciated."

Roche Touts Drug For ESMO

Roche Drug T-DM1 Outdoes Herceptin With Chemotherapy

By Rob Waters - Oct 8, 2010 3:02 PM ET Tweet (1)LinkedIn Share

Roche Holding AG said its two-drug treatment combining an anticancer agent with Herceptin, the company’s $5.27-billion breast cancer drug, was about as effective as, and caused fewer side effects than, Herceptin with chemotherapy.

The results, presented at the European Society for Medical Oncology meeting in Milan, were the first to measure the effectiveness of Roche’s experimental drug called trastuzumab- DM1 as an initial therapy in patients with a particular subtype of breast cancer. T-DM1 is a member of a new class of experimental drugs called antibody-drug conjugates that combine antibodies and anticancer drugs.

BSD Medical's Stock is Rising Fast: BSDM

BSD Medical is going up like hotcakes these days. I still think there is plenty of room for future growth. Today's trading is BSDM 3.16 +0.19 (6.40%) They recently had FDA approval for cancer treatment medical device. I don't think it's too late to get on board with this stock and see it as a real Long Term Growth Potential. They are selling their newly acquired 510K approved products at a rapid pace to Cancer Treatment centers across the country.

Wikinvest is a great Market Tool: BSD Medical




Texas Oncology Acquires Hyperthermia System from BSD Medical

Seattle Genetics Reports Disappointing Phase II Data For AML, and Upcoming Clinical Trial Results for NHL

Wikinvest-Seattle Genetics (SGEN)

Disappointing news reported from Seattle Genetics today. I actually like the stock after the price bottoms out as they are focusing their efforts on Non-Hodgkins Lymphoma drug, brentuximab.  Wait for the massive sell-off in the next week or two and wait for Clinical Trials results to come out in about 6 weeks from Phase II testing for NHL.  I anticipate a massive sell-off in the next couple of days after todays disappointing clinical trials news on a separate medication for AML, acute myeloid leukemia.

KEYWORDS: Antibody-Drug Conjugates, Millenium Pharmaceuticals, Seattle Genetics, AML, Monoclonal Antibody Therapeutics, Hodgkin Lymphoma

Seattle Genetics is ditching further development of its clinical-stage acute myeloid leukemia (AML) candidate lintuzumab (SGN-33) after a Phase IIb trial failed to show the drug extended overall survival. The firm says it will now focus on the rest of its clinical pipeline, headed by the Phase III-stage Hodgkin lymphoma drug, brentuximab vedotin, which is being developed in collaboration with Millennium Pharmaceuticals.

Is ArQule The Next Dendreon?

Image via Wikipedia This stock has been on my radar for a couple of months. Arqule could be the next Dendreon. It is a cash cow and needs a little more clinical trial data before I pull the trigger but I will continue to watch this stock. I will keep you up to date if anything changes. Currently AQ197 is entering Phase III clinical trials for non-small cell lung cancer with Japanese partner Daiichi Sankyo.

ArQule:  (ARQL)
Daiichi Sankyo:  (Tokyo: 4568)

ArQule's sky-high, but there still could be upside

By Val Brickates Kennedy, MarketWatch June 4, 2010

iCAD Veralook Colon Cancer Screening Technology

Image via Wikipedia I really like this stock for Long Term Growth Potential. iCAD

Radient Pharmaceuticals Emerging Cancer Screening Technology

Image via Wikipedia Radient Pharmaceuticals (AMEX: RPC) is having one impressive day. Today it announced target market details for the commercialization of its Onko-Sure in vitro diagnostic cancer test.

It received approval FDA approval 24 months ago and has been validating test kits for oncologists, gastroenterologists, and lab directors for use. The company is now in position for marketing and commercializing Onko-Sure technology.

Nanoshell particles

Image via Wikipedia Nanoparticle Cancer Treatments 100% Eradication
 by James Rickman

Nanoshell therapy is comprised of three components:
- an off-the-shelf near infrared laser source
- an off-the-shelf interstitial fiber optic probe delivers the laser energy to a site near or inside the tumor
- the investigational nanoshell particles, a near-infrared absorbing, inert material designed to absorb and convert the laser energy into heat.

FDA approve's Dendreon's Provenge

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Here's Dendreon's newswire on it's approval of Provenge. Stock hit an all time high of 57.55 and has tapered off a bit around the 53 point range. This is a quality stock and it's profits should help the bottom line with this big news on April 29th, 2010.

SEATTLE, April 29, 2010 /PRNewswire via COMTEX/ --Dendreon Corporation (Nasdaq: DNDN ) today announced that the U.S. Food and Drug Administration (FDA) has approved PROVENGE(R)
(sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.