Poniard Pharmaceuticals: Positive Phase 2 News and Patent Portfolio Could Make it a Good Buy
|Written by Gene Quinn
Patent Attorney & Founder of IPWatchdog, Inc.
Principal Lecturer, PLI Patent Bar Review Course Posted: March 7, 2010 @ 5:32 pm
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Over the weekend I was doing some research on stocks that I might be interested in purchasing. In a previous life I was somewhat active in the stock market, and I am starting to once again get involved in the market. It might be news to some, but back in 1999 when I acquired IPWatchdog.com the thought was that it would be used by me and a group of friends who together with me formed a think tank to build a business evaluating companies and stocks based on their intellectual property portfolios, of which patents are a primary component.
Obviously, that didn’t go as planned. Many of those involved in our fledgling think tank went on to bigger and better things with high paying jobs. Having acquired the domain name personally, after the think tank fell apart I decided to take IPWatchdog.com in a different direction, particularly after the bubble burst. In any event, I have long wanted to try to at least occasionally get back to what was to be the IPWatchdog.com roots. With this in mind I figured I would give it a try when I came across something interesting. I think I have, but of course you will be the judge no doubt. What I can say is that I have not been paid to write anything positive about this or any other company I may write about in the future, and the analysis is mine alone, relying on information available to the general public.
First, the goal was never going to be to say to the reader buy this or buy that, but rather to provide additional information that might not otherwise be readily available to investors. I am not sure that evaluation of an intellectual property portfolio, or patent portfolio, in and of itself can provide actionable intelligence. Nevertheless, the way I personally decide what to buy is to look at a bunch of different information and then when there are enough things pointing in the right direction I buy. So with that being said, let me caution readers that I am not saying that you should buy based on what I am about to write, but it is interesting information that depending on your risk tolerance could help make a decision.
As I was searching I perused data on the most active stocks for Friday, March 5, 2010 on ClearStation.com. While I don’t try and time the market or any stock, per se, I do think that trends can be helpful to identify what others are thinking and doing, which of course does affect stock price. I personally like to buy stocks that have strong volume, which makes it easier to dump shares if need be. As I was doing this I came across Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), a biopharmaceutical company focused on innovative oncology therapies. Shares of PARD were only up $.10 on the day, closing at $1.77, with a high of $2.09 and a low of $1.63, but volume of shares traded was 9,127,941, which is a positive increase of 140.96%, so something seemed to be going on.
With a little digging, not much really, I found a press release from the company announcing the presentation of positive final data, including survival data, from the Company’s Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The final data showed that picoplatin, in combination with docetaxel and prednisone, the current standard of care for CRPC, produced a clinically meaningful benefit in patients as measured by overall survival, progression-free survival (PFS) and prostate specific antigen (PSA) response rate. These results also demonstrated that picoplatin can be safely administered with full doses of docetaxel and prednisone.
I then decided to do some more research to learn more about the company, about picoplatin and about what patents and pending patent applications they have. I found three pending US patent application on the use of picoplatin to treat colorectal cancer. These are:
Use of picoplatin to treat colorectal cancer
United States Patent Application 20090197854
Filed February 6, 2009
Published August 6, 2009
Use of picoplatin to treat colorectal cancer
United States Patent Application 20090275549
Filed May 12, 2009
Published November 12, 2009
Use of picoplatin to treat colorectal cancer
United States Patent Application 20090306034
Filed May 13, 2009
Published December 10, 2009
Each of these pending patent applications has a common specification, which explains that picoplatin is a platinum analogue that has demonstrated synergy with 5-FU in vitro in pre-clinical studies and has undergone extensive Phase 1 and 2 testing in a variety of cancers. Like other platinum analogues, picoplatin causes cell death by the formation of covalent cross-links in DNA that interfere with DNA replication and transcription, leading to cell death. Cisplatin, the first platinum analogue, was introduced approximately 20 years ago and is still widely used. The approval of cisplatin was followed by approval of carboplatin, and most recently by that of oxaliplatin.
Treatment with platinum analogues is limited by their toxicity. While neurotoxicity and nephrotoxicity are the main dose-limiting toxicities (DLT) observed following cisplatin treatment, myelosuppression is most significant following carboplatin treatment. Carboplatin is known to cause cumulative dose-related toxicity that results in slow bone marrow recovery. Peripheral neurotoxicity is well documented in patients treated with oxaliplatin. The unacceptable nephrotoxicity, oto-, and neurotoxicity associated with earlier platinum analogues has not been reported with picoplatin either in animal studies or in clinical trials.
The efficacy of platinum analogues is also limited by several (intrinsic or acquired) mechanisms of resistance, including impaired cellular uptake, intracellular inactivation by thiols [e.g., reduced glutathione], and enhanced DNA repair and/or increased tolerance to platinum-DNA adducts. Pre-clinical studies indicate that picoplatin can overcome these three mechanisms of resistance.
In Phase 1 studies, indications of activity were seen in subjects with ovarian cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), colorectal cancer, head and neck cancer, renal cell cancer, thymic cancer, pancreatic cancer, stomach cancer, leiomyosarcoma, liver cancer, mesothelioma, and prostate cancers. In Phase 2 studies, indications of efficacy were seen in subjects with ovarian, NSCLC, SCLC, mesothelioma, prostate cancer, and breast cancer.
An embodiment of the present invention provides a method of treatment of colorectal cancer, comprising administering to a patient afflicted with colorectal cancer picoplatin, 5-fluorouracil (5-FU), and leucovorin, wherein 5-FU and leucovorin are administered intravenously at least twice at intervals of about 2-6 weeks and the picoplatin is administered with the leucovorin and 5-FU every other time that the fluorouracil and leucovorin are administered.
Now here is what really caught my attention about PARD, on November 13, 2009 the stock was trading at $7.58, and on Monday, November 16, 2009 it dropped like a rock to $1.83, where it has largely stayed in a trading range plus or minus since. So what happened? On November 16, 2009, PARD announced what they called a positive Phase 3 study of picoplatin for use to treat small cell lung cancer patients. Those treated with picoplatin had an 11% reduction in the risk of death compared to patients treated with current best practices, which was not a positive enough result to be statistically significant. As is often the case with companies like this in the biotech sector, bad news is devastating to a stock. It is also true that stocks in the biotech sector also do quite well on good news. Back in March 2009, PARD was trading at about $1.70 to $1.80 before running up to a high of $9.14. So could this positive Phase 2 news of picoplatin and colorectal cancer be the precursor to another run up? It seems to me that this Phase 2 news is good news, and after PARD fell off a cliff on November 16, 2009, it fell to where it is now, so good news could well result in a rise from this threshold level.
In evaluating this information it is important to note that more than two million American men are currently living with prostate cancer, and it is the most common cancer, other than skin cancers, among men in the U.S. In 2009, an estimated 192,280 new cases of prostate cancer were expected to be diagnosed. Prostate cancer is the second leading cause of death in American men, behind only lung cancer, with an estimated 27,360 deaths in 2009.(2) All patients with metastatic prostate cancer eventually become refractory to hormone treatment. Docetaxel in combination with prednisone is the current standard of care in the United States. According to IntrinsiQ, 88.5 percent of U.S. patients received a docetaxel-containing regimen for first-line treatment of CRPC in 2008. To date, a docetaxel-containing regimen is the only FDA approved treatment regimen proven to prolong the lives of patients with CRPC.
“Safety and efficacy results from this study, particularly the overall survival data, are encouraging and suggest that picoplatin in this combination regimen has the potential to play a meaningful role in the treatment of metastatic prostate cancer,” said William K. Oh, M.D., professor of medicine and urology and chief, Division of Hematology and Medical Oncology, Tisch Cancer Institute at Mount Sinai School of Medicine. “The results also support the study of picoplatin as a first-line treatment for advanced prostate cancer, a disease for which too few treatment options currently exist.”
“We believe these results reflect the promise of picoplatin as a safe and effective platinum chemotherapeutic agent in prostate cancer, and suggest picoplatin could play a significant role in the treatment of other tumor types where platinum and taxane chemotherapies are currently used, further supporting picoplatin’s value proposition to potential partners,” said Ronald Martell, chief executive officer of Poniard. “We intend to consult with our clinical advisory board and the U.S. Food and Drug Administration to finalize registration strategies in prostate cancer while simultaneously exploring potential partnership opportunities to support the continued development of picoplatin in multiple solid tumor indications.”
Results from the positive study included:
- Median overall survival was 21.4 months in 29 patients who received picoplatin in combination with docetaxel and prednisone. Data from published literature report a median overall survival of 18.9 months for patients who received docetaxel 75 mg/meter squared and prednisone 5 mg alone.
- Progression free survival was 7.4 months.
- PSA response was achieved in 78 percent of evaluable patients. Data from published literature report a PSA response of 45 percent in patients who received docetaxel 75 mg/meter squared and prednisone 5 mg alone. In addition, 30 percent of these patients experienced PSA level normalization following treatment with the picoplatin, docetaxel and prednisone combination.
- Picoplatin was safely administered with full-dose docetaxel and prednisone for up to 10 cycles of therapy. Neuropathy was not observed in this study. Data from published literature report evidence of neuropathy in 30 percent of patients, including severe neuropathy (Grade 3/4) in 1.8 percent of patients receiving 75 mg/meter squared docetaxel and prednisone alone every three weeks.
- Neutropenia was the most common hematologic adverse event, and was managed with supportive care. In contrast to data from picoplatin monotherapy studies, thrombocytopenia was less severe and less frequent when picoplatin was administered in combination with docetaxel.
It is also worth noting that PARD has a family of patents related to the treatment of bone cancers that will soon be expanding by one. On October 6, 2009, the United States Patent and Trademark Office sent a notice of allowance to PARD and the issue fee was paid on January 6, 2010. The family of patents is listed below, followed by a brief summary I cut and paste together from the common specification.
Treatment of bone-associated cancers
United States Patent 7408046
Issued August 5, 2008
Skeletal-targeted radiation to treat bone-associated pathologies
United States Patent 7605239
Issued October 20, 2008
High dose radionuclide complexes for bone marrow suppression
United States Patent 7378077
Issued May 27, 2008
This invention, covered by the above patents and pending patent application, provides a method for selectively, rapidly, and effectively suppressing bone marrow or to treat a pathology associated with (in or near) the bone or bone marrow. In one aspect, the method comprises administering to a mammal in need of such treatment a high dosage of a complex of a bone marrow suppressing radionuclide with a bone targeting ligand, such as an aminophosphonic acid. Such pathologies include cancer, autoimmune diseases, certain infections and certain hematopoietic genetic disorders.
A preferred embodiment of the invention provides a method to increase the efficacy of chemotherapy, particularly high dose or intensive chemotherapy, without a substantial increase in total side effects, such as urinary tract side effects, and more preferably, without the need for total body irradiation (TBI).
For those disease states where the treatment regimen requires bone marrow suppression, the present invention is particularly advantageous since it provides a means of achieving selective reduction in the hemopoietic cell population, without having to resort to external irradiation of the subject, e.g., to TBI, resulting in minimal damage to non-target tissues. The reduction in the radiation dose delivered to non-target tissues (as compared to the use of TBI alone), provides the opportunity to use the same or increased amounts of conventional chemotherapeutic regimens, particularly non-radioactive antineoplastic (“anti-cancer”) agents that per se suppress bone marrow, such as alkylating agents.
It may be possible to completely eliminate the use of targeted radiation or TBI in certain patient populations, such as those under 55 years of age, while retaining equivalent efficacy. It may also be possible to increase the efficacy of regimens in which TBI is desirable, but too hazardous to use, as in older patients (>55 years of age). However, if it is desirable to employ targeted irradiation or TBI in conjunction with the bone marrow suppression method described herein, for example, in the treatment of leukemia, it can be possible to reduce the radiation dosage used for the total body irradiation and still obtain the same or higher level of reduction of leukemic cells.
Other patents held by PARD include:
Compounds and therapies for the prevention of vascular and non-vascular pathologies
United States Patent 7511070
Issued March 31, 2009
Bridged aromatic substituted amine ligands with donor atoms
United States Patent 7268220
Issued September 11, 2007
Therapeutic and diagnostic compounds, compositions, and methods
United States Patent 7385042
Issued June 10, 2008
PARD went through a reverse stock split on September 25, 2006, and since that time it has ranged from $1.48 per share to $8.63 per share (see chart below) so at these prices there doesn’t seem to be much down side, at least after holding its current range since bad Phase 3 news relating to the treatment of small cell lung cancer.
For those interested, Poniard Pharmaceuticals, Inc. will hold a conference call on Monday, March 8, 2010 to discuss the Company’s fourth quarter and fiscal year 2009 financial results and provide a corporate update. Ronald A. Martell, chief executive officer, Michael S. Perry, president and chief medical officer, and Greg Weaver, senior vice president and chief financial officer, will host the call beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). A press release for the fourth quarter ended December 31, 2009, will be released before the market opens and prior to the conference call on March 8, 2010.
If you wish to participate in the live call by telephone, please dial 866-543-6403 (United States) or 617-213-8896 (International). The passcode for the conference call is 50673823. In addition, the live conference call is being Webcast and can be accessed on the “Events” page of the “News & Events” section of the Company’s Web site at http://www.poniard.com . A replay of the Webcast will be available on the Company’s Web site for 10 days.
So am I buying? I think I more or less have to put my money where my mouth is, but I will likely listen in on the call or at least read the press release just to make sure, but as of the time this article was written I do not presently have a position in PARD. The stock looks good in that it is above the 13 day moving average, and is closing in on crossing over the 50 day moving average. I think with the steep sell off in November 2009 waiting for the stock to cross over the 200 day moving average, which would really signal meaningful and growing interest, is not wise. The 200 day moving average is just below $5, so if signs of growing interest on at least decent Phase 2 news is correct there will be a lot of ground already covered by the time the 200 day moving average is crossed.- - - - - - - - - -
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Posted in: Biotechnology, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, Pharmaceutical
About the Author
Gene Quinn is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.