For all new investors in CRIS and for old timers for reminders as to why we are still invested. Here are links to articles to help understand CRIS, some fairly recent while others are old. In addition to these links, I highly recommend going to www.curis.com and look through some of the 2009 and 2010 presentations to see pictures in their presentations of the dramatic results in the BCC testing.
The first link is to the government website showing all clinical trials currently underway for the drug being developed by Roche under license from CRIS.
List of all clinical trials for GDC-0449.
Recent story by Currin Research
From May, 2008 in a Phoenix paper “'Dramatic results' for experimental cancer drug”
Forum for those suffering from Gorlins syndrome using GDC 0449.
Click on the above link to enter as a Guest so you don’t have to register to read the posts. From the posts it sure sounds like the drug works for Gorlin's syndrome.
Link below for an article discussing preliminary results for those with Gorlins syndrome
From One-Eyed Sheep To Cancer Cure? Article from Forbes 09/03/09:
The Curious Case of The One-Eyed Sheep From 2005
Seeking Alpha article from 2/19/10
This weeks story from the street.com
Good luck with your investment.
Click on the Delphi Forum link in the first message in this thread and you can see messages from actual Gorlins patients who use the drug. Once you enter the site as a guest, you can see various threads concering Erivedge. Did I mention that I hate Yahoo at times?
Not sure when this interview was actually conducted (at least a year old imo) but it is an interview with the lead investigator Frederic De Sauvage and Jennifer Low of Gennetech. It is worth watching IMO. The page also has a link to the transcript of the interview. It may be a little old but still worth watching, takes only 7 minutes.
I searched uspto.gov and found 62 approved patents assigned to Curis, Inc., or Curis/Genentech since 2001. I found 27 patents assigned to Curis or Curis/Genentech in which the word Hedgehog was present in the abstract. In addition, I found multiple Curis, Inc. patent applications yet to be approved, including one that was filed on 1/13/2011. Curis's IP makes them very valuable for many hedgehog inhibition strategies. Almost all are small molecules, but there is at least one that is a humanized monoclonal antibody. Very interesting.
JME is Jean-Marie Eveillard who manages Arnhold and S. Bleichroeder Advisers, LLC which was the top holder of CRIS stock and has been for years. Here is a link to the most recent institutional ownership as of 9/30/10.
from 10k continued
"Under the terms of the June 2003 agreement with Genentech, we granted Genentech an exclusive, global, royalty-bearing license, with the right to sublicense, make, use, sell and import small molecule and antibody Hedgehog pathway inhibitors for human therapeutic applications, including cancer therapy. We had responsibilities to perform certain funded preclinical research activities through December 2006. In November 2008, Genentech granted a sublicense to F. Hoffmann-LaRoche, Ltd (Roche) for non-U.S. rights to GDC-0449. Roche received this sublicense pursuant to an agreement between Genentech and Roche under which Genentech granted Roche an option to obtain a license to commercialize certain Genentech products in non-U.S. markets. In February 2010, we announced that Chugai Pharmaceutical Co., Ltd. had exercised its right of first refusal for the development and commercialization in Japan of GDC-0449 under an existing agreement with Roche.
Genentech and Roche have primary responsibility for worldwide clinical development, regulatory affairs, manufacturing and supply, formulation and sales and marketing. We are eligible to receive cash payments for regulatory filing and approval objectives achieved and future royalties on products developed outside of the U.S., if any, under our June 2003 collaboration agreement with Genentech. We are eligible to receive up to $115,000,000 in contingent cash payments under the terms of our June 2003 collaboration for the development of GDC-0449 or another small molecule, assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives, of which we have received $18,000,000 to date, including $6,000,000 in 2009 upon Genentech's initiation of its pivotal phase II clinical trial in advanced BCC and an aggregate of $6,000,000 in 2008 upon Genentech's initiation of phase II clinical trials in metastatic colorectal cancer and metastatic ovarian cancer. We are also eligible to receive royalties on sales of any Hedgehog pathway inhibitor products that are successfully commercialized by Genentech and Roche. For GDC-0449, we are entitled to a mid-to-high single digit royalty, which escalates within this range with increasing product sales. In certain specified circumstances, the royalty rate applicable to GDC-0449 may be decreased to a low-to-mid single digit royalty."
Information on the Genentech agreement from the 2009 10k filed in March 2010, some of which is now outdated such as the reference to the colorectal and ovarian studies. It states "We are also eligible to receive royalties on sales of any Hedgehog pathway inhibitor products that are successfully commercialized by Genentech and Roche." So we know we will receive royalties on all product sales no matter the indication IMO.
Our most advanced program is our Hedgehog pathway inhibitor program under collaboration with Genentech, Inc., a wholly-owned member of the Roche Group. The lead drug candidate being developed under this program is GDC-0449, a first-in-class orally-administered small molecule Hedgehog pathway inhibitor. The Hedgehog pathway is normally active during embroyonic development and regulates tissue and organ formation. Malignant activation of the hedgehog pathway is believed to play a central role in the proliferation and survival of certain cancer cells, including in basal cell carcinoma, or BCC, as well as colorectal, ovarian, small cell lung, pancreatic and breast cancers among others. Genentech and Roche are currently conducting three clinical trials of GDC-0449, including a pivotal phase II trial in advanced BCC that was initiated in February 2009 and two phase II clinical trials of GDC-0449, in metastatic colorectal cancer and in advanced ovarian cancer, which were initiated in 2008…
Other GDC-0449 Clinical Studies. In addition to the ongoing clinical trials that Genentech and Roche are conducting, Genentech and the National Cancer Institute, or NCI, entered into a collaborative relationship that allows the NCI to study GDC-0449 in additional potential cancer indications. Under this arrangement with NCI, third-party investigators began enrolling patients in a phase I clinical trial that is designed to evaluate dose and safety of GDC-0449 in young patients with medulloblastoma and a phase II trial to test the molecule in adult medulloblastoma patients. A phase I clinical trial in pancreatic cancer patients and randomized phase II clinical trials in small cell lung cancer and advanced stomach or gastroesophageal junction cancer patients were also initiated and an additional phase II study is planned in glioblastoma multiforme patients under this NCI arrangement. Furthermore, an investigator-sponsored study evaluating GDC-0449 in patients with basal cell nevus (Gorlin) syndrome has been initiated….
It has been written that Genentech discussed with the FDA the possibility of a successful PHII obviating the need for a PHIII. If this is true and the results are good, but a PHIII is required, do you think that this will have an immediate negative affect on the pps?