Cougar Biotechnology (CGRB)

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Here's a re-post from SI on Paramount, the Rosenwald related firm that has done some financing for Cougar -

>>> Paramount has a terrible rep from a few years back, in particular Genta will taint them forever. But the current Paramount model is pretty interesting.

They find a ceo they like, form a company with say $5M. ceo builds a small mgt team and looks for product to inlicense. This is how Cougar was started. At some point the sooner the better its completely hands off. As you can see the $50M cgrb offering was with Leerink.

It's a great business model for Paramount, help launch a company, modest upfront investment at risk, collect banking fees when they raise money through their capital arm. If the companies succeeds they can make a huge return all around without much being at risk.

Here's a list of some Paramount started companies, some good ones and some duds. chtp, ivph, gnta, dsco, kerx, cgrb, idev, adh, ntec, hnab, cypb, jav, nvd, ctic, ptn, crme.

I think Paramount has cleaned up their act, but I'm sure there's a lot of people out there who will never invest in these and future paramount companies because of the connection. <<<

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Cowen initiates with outperform on Cougar -

>>> 09:32 am Cougar Biotechnology: Cowen & Co initiates Outperform. Cowen initiates CGRB with an Outperform saying the lead product CB7630 is supported by compelling Phase I and Phase II data and has the potential to be a blockbuster product in the large and dynamic prostate cancer market. The firm expects Phase III trials in chemotherapy-refractory patients to begin in H1:08. Additional product candidates CB3304 and CB1089 round out Cougar's pipeline. The firm believes CGRB shares will significantly outperform the market as investors gain greater comfort and appreciation for CB7630's $500 mln+ sales potential. <<<

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Cougar's interim Phase 2 results from AACR -

>>> Cougar Biotechnology Presents Positive CB7630 Clinical Data at AACR Annual Meeting Late-Breaking Clinical Trials Session
Tuesday April 17, 1:20 pm ET

Interim Phase II Results Confirm Efficacy of CB7630 in Both Chemotherapy Naive and Chemotherapy Refractory Prostate Cancer Patients

LOS ANGELES--(BUSINESS WIRE)--Cougar Biotechnology, Inc. (OTCBB:CGRB - News) today announced that positive Phase I and Phase II data on the Company's prostate cancer drug candidate CB7630 (abiraterone acetate) was presented at the American Association for Cancer Research (AACR) Annual Meeting in Los Angeles, California. The data was presented in two oral presentations as part of a special session, Phase II Proof of Concept Late-Breaking Clinical Trials. These presentations are further detailed below:
Inhibition of androgen synthesis results in a high response rate in castration refractory prostate cancer: A Phase II clinical trial

The Phase I/II trial of CB7630 was conducted at The Institute of Cancer Research and at The Royal Marsden NHS Foundation Trust in the United Kingdom. In the trial, CB7630 was administered orally, once daily, to chemotherapy-naive patients with castration refractory prostate cancer (CRPC), who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies, including antiandrogens, diethylstilboestrol and dexamethasone. To date a total of 38 patients have been treated in the Phase I/II trial, including 15 patients treated in the Phase I portion of the trial and 23 patients treated in the Phase II portion of the trial. In his oral presentation, Dr. Gerhardt Attard from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust in the United Kingdom reported that in the 38 patients treated in this trial, CB7630 was well tolerated at doses as high as 2000 mg/day with minimal toxicity. Moreover, no dose limiting toxicity has been observed in the trial to date.

Of the 30 patients who were evaluable in the Phase I/II trial, 18 patients (60%) experienced confirmed declines in prostate specific antigen (PSA) levels of greater than 50%, with 10 of the 30 patients (33%) experiencing PSA declines of greater than 90%. Of the 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 11 patients (55%), with 7 patients demonstrating ongoing stable disease and 3 patients experienced regressing bone disease. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use. Circulating tumor cells (CTC) were detected in 14 of 31 patients and changes in CTC counts were shown to correlate with changes in PSA.

Currently 27 (90%) of the 30 patients in the Phase I/II trial remain on study and continue to be treated with CB7630. Of the 15 patients in the Phase I portion of the trial, 12 patients (80%) are still receiving treatment with CB7630, with the average patient having received the drug for over 8.5 months and 4 patients having received the drug for over 12 months.

Abiraterone, an oral, irreversible CYP450c17 enzyme inhibitor appears to have activity in post-docetaxel castration refractory prostate cancer patients

The Phase II trial is being conducted at numerous locations in the United States and United Kingdom. In the trial, CB7630 is administered orally, once daily, to patients with castration refractory prostate cancer who have failed treatment with first line docetaxel based chemotherapy. The oral presentation was made by Dr. Alison H. M. Reid from The Institute of Cancer Research.

To date, 19 patients have been treated in this Phase II trial, with 13 of the patients having been treated for over 3 months. Of the 19 patients who have been treated, CB7630 was well tolerated with only minimal toxicity in this post-docetaxel population. In the 13 patients who have been on study for over 3 months, 8 patients (62%) experienced confirmed declines in PSA levels of greater than 50%, with 2 of the 13 patients (15%) experiencing PSA declines of greater than 90%. All 19 patients in this trial are still receiving treatment with CB7630. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use. Circulating tumor cells (CTC) were detected in 14 of 19 patients and changes in CTC counts were shown to correlate with changes in PSA.

Dr. Arie S. Belldegrun, M.D., FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology, said, "The data from both trials of CB7630 presented at AACR continues to support the potential role of the drug in the treatment of CRPC. Interestingly, CB7630 showed strong evidence of antitumor activity in patients who were both chemotherapy naive and chemotherapy refractory, both of which represent significant unmet medical needs in prostate cancer. We continue to have strong confidence in CB7630's potential in both of these patient populations." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology, added, "We are pleased to be able to present data from both of these CB7630 trials at AACR. We look forward to continuing to provide updates on these ongoing trials at future cancer conferences and greatly look forward to the continued development of CB7630 in both the second line hormone therapy and second line chemotherapy settings."

About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based biotechnology company established to in-license and develop clinical stage drugs, with a specific focus on the field of oncology. Cougar's oncology portfolio includes CB7630, a targeted inhibitor of the 17-alpha hydroxylase/c17,20 lyase enzyme, which is currently being tested in Phase II clinical trials in prostate cancer; CB3304, an inhibitor of microtubule dynamics, which is currently in a Phase I trial in hematological malignancies; and CB1089, an analog of vitamin D, which has been clinically tested in a number of solid tumor types.

Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com. <<<

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Cougar Biotechnology - Feuerstein mentioned them recently (see article excerpt below) and I thought they looked interesting. They had a presentation at the CIBC Investor Conference in April, which is still available for replay. I was skeptical at first of the CEO (he was previously a biotech stock analyst), but I thought his CIBC presentation was impressive. They appear to have a capable management team, with their new regulatory affairs guy coming from Amgen (was involved with PMab). The company just raised $50 mil. The stock is on the bulletin board but trades in the low-mid $20s, and apparently they'll be going onto a larger exchange at some point. I see that Lindsay Rosenwald is on the BOD, though I'm not sure of the extent of his involvement with the company. I think he holds some warrants from a prior financing.

Anyway, I'd be curious to hear opinions on the company's prospects. Their lead program looks very interesting - CB-7630, an inhibitor of the 17-alpha hydroxylase/C17,20 lysase enzyme, in Phase 2 for prostate cancer. They also have CB-3304, an inhibitor of tubulin dynamics, in phase 1 for hemotological malignancies, and CB-1089, an analog of Vitamin D, tested in various solid tumors. The CIBC presentation is well worth hearing, and the slides provide a good overview -


>>> Feuerstein's Biotech-Stock Mailbag
By Adam Feuerstein
Senior Writer
5/5/2007 10:36 AM EDT
URL: http://www.thestreet.com/newsanalysis/biotech/10354681.html

It's Saturday, which means the Biotech-Stock Mailbag has returned. Responding to your emails brings me great joy, so keep those letters coming.

... Martin M. chimes in about Cougar Biotechnology (CGRB) :

Cougar has a very promising prostate cancer drug that looks interesting. Abiraterone is an oral, irreversible CYP450c17 enzyme inhibitor that appears to have activity in post-docetaxel, castration refractory prostate cancer patients. It is safe ... and has shown some dramatic effects on PSA levels in later stage prostate cancer patients. The company is super small (20 employees) but its presentation generated a lot of buzz at the [April 15-18 American Association for Cancer Research] meeting. Another Dendreon perhaps?

Does everyone understand that? You think Martin has a science background? I agree with him. I'm also excited about Cougar and its prostate cancer drug abiraterone.

What I'm not so hot on right now is the fact that Cougar trades on the bulletin boards and is, therefore, very illiquid. I'm told the company has plans to list on a more traditional stock exchange soon, which should take care of the liquidity issue. Whether all the hedge funds that currently own the stock decide to use that new liquidity to cash out remains to be seen. Just be careful.

But let's talk about abiraterone in more simple language. The drug inhibits testosterone production with the potential to drop androgen levels below "castration" levels even in patients who no longer respond to current androgen-deprivation therapy.

A quick reminder: Prostate cancer feeds off of testosterone, so prostate cancer patients are treated with hormone therapy to block the production of testosterone and keep their cancer in remission. This can be an effective therapy for a long time, but eventually, the prostate cancer cells become "independent" of hormone therapy and start growing again.

As it stands now, doctors do have some drugs to use when their prostate cancer patients stop responding to initial hormone therapy. (This is before patients are treated with chemotherapy.) Early data suggests that abiraterone might be a better drug in this setting, which represents a sizeable commercial market opportunity.

There are also early data to suggest that abiraterone can be effective for prostate cancer patients on chemotherapy, specifically as a second-line treatment once first-line drugs like Taxotere are no longer working. This is a smaller market, but one that probably has a quicker route to approval.

So, yes, Martin is right. Cougar might be another Dendreon. In fact, depending on how abiraterone is used, it might impinge on Provenge's market opportunity. Then again, it might not. Regardless, I think Cougar is a cancer stock worth keeping on your radar screen, especially once it moves to a larger exchange. <<<