“These are early results but they are promising, says the study’s lead author, Ayalew Tefferi, M.D. a hematologist at Mayo Clinic. “Some patients in our clinical trial taking imetelstat obtained dramatic responses and there have been some complete responses which is almost unheard of for drug therapy in this disease.”
Charles Duncan - Piper Jaffray
Been a long time.
John Scarlett - President and CEO
It seems like…
Charles Duncan - Piper Jaffray
You’ve been having this…
John Scarlett - President and CEO
Yeah. It seems like I have been having this conversation for a long time I guess. The results were published not too long ago. The abstract will be presented by Dr. Tefferi in a podium presentation on Monday late afternoon. I think it's 4.45 something like that at ASH in New Orleans. I encourage everyone to go and listen to it. And we'll probably have some comments hopefully in the investor event shortly thereafter.
So at the end of the day, we have not commented very much about the specifics of the abstract, we're still under in a embargo from ASH in doing so. So I'm afraid, probably you have to come to ASH or look into our webcast in order to hear our take on it. But I'm happy to answer any other questions that I can. Hopefully that's a good background for what we hear.
John Scarlett - President and CEO
Well, I think you have to realize that this is an IST. And at the end of the day I Ayalew Tefferi wrote that abstract and had a definitive decision making capability as to what he thought were the important things to emphasize and I would recommend that anyone who read the abstract again with that in mind, these were the things he emphasized the things that he thought were important in the field. And he is not a he is a very thoughtful person. So, I would just say that. We didn’t write it and we didn’t have control over it. For that reason, one of the things that we hope to be able to do at ASH, at an investor presentation and analyst presentation that evening after, we will send a press release out about that, but at that evening after this presentation, we hope to be able to make some further commentary that will clarify some of these questions as to individual patient responses and so forth. But that was -- those were -- that’s what he thought wa
"NO NEGATIVES". So many promising medicines have been put on the sidelines by an unforeseen side-effect that was "worse than the cure". This does not seem to be a factor with Imetelstat. Imetelstat obviously works, but we will have to see from ASH, if we can put it in the "great" or "breakthrough" category.
The CELG-OMED partnership gets me speculating about a partner for Geron. Since Chip mentioned Gilead in a previous talk, that would be my number one choice. They have similar interest, deep pockets, and like to combine drugs for improved outcomes.
Chip PJ talk was definitely encouraging.
So far I haven't heard any reversals of previously promising information and abstracts. The best news today would be "no negatives", and Chip being generally encouraging about ASH, and the future beyond ASH. What time does Chip speak? Chip and Duncan can have impact by their tone and demeanor.
I think you are wrong. Geron has a credibility problem going back to hESC's. ASH will cure that, or make it worse. It is possible that ASH will have limited effect, if the news if "lukewarm", that is that Imetelstat has some limited effect, but is only marginally promising. Mayo knows much, but is revealing little before ASH.
ASH means everything. Geron, after the embryonic-human-stemcell set backs, became a company that no one trusted, especially old-time and potential new investors. Some people are still saying that Imetelstat, and the whole telomere premise, are either faked or greatly exaggerated. Those fears are holding the stock price in a very narrow channel (~$4.50 to ~$5.75). ASH could create new confidence in Geron, and "breakout" to much higher prices, if the news at ASH has no "negative-kickers". If it is "extra-positive" the sky is the limit.
Obama is not running for reelection. He is charting the right path for the USA, and leading the way for our first woman president. This is the century of the woman (gender-gap), and the time for the demise of southern white male supremacy. Very soon we will be going from RomneyCare & ObamaCare to HillaryCare.
MENLO PARK, Calif., - Geron Corporation announced that John Scarlett, M.D., President and Chief Executive Officer, will present an overview of the company at 12:30 p.m. Eastern Time on Wednesday, December 4, at the 25th Annual Piper Jaffray Healthcare Conference in New York.
Geron is a clinical stage biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies.
Anna Krassowska, Ph.D.
Investor and Media Relations
I will be listening for negatives. If there are none, I believe ASH will be a positive experience, and Geron will push higher.
So far I have been correct about Geron. Mayo could disappoint on Dec. 9 and tell us that everything that they believed early-on, turned in into a "medical nightmare" and Imetelstat is dangerous. it doesn't look that way to me, but you obviously disagree. Of course, I do not have a crystal ball, so my guesses about the future are based upon what I read, hear and commonsense. That does not always work, and investments in any common stock are risky.
The abstracts from Mayo have been encouraging. The PJ PhD in biotechnology ( with the Mayo contacts) has been very accurate. It looks like Dec. 9 (ASH) will provide more good news, and $10 will be the new floor.
The "DOG OF THE DOW" will be at the forefront of the coming USA infrastructure boom, and the improving job market. The economy is now in the hands of the 4th part of government (Fed), that was designed to be independent of dysfunctional congressional politics. Bernanke and Yellen are saviors.
SAPIEN 3 Heart Valve
PLANO, TX, November 14, 2013 – The Heart Hospital Baylor Plano became the first in the nation to treat a patient with the catheter-based SAPIEN 3 heart valve using the transapical approach (through the ribs). This new phase of a clinical trial, also known as Partner II, may offer older patients with inoperable heart valve conditions a second chance at life.
Edwards Lifesciences Corp. created the transcatheter aortic valve replacement (TAVR) treatment option, which can give patients the opportunity to have their valves replaced without open-heart surgery. While a version of this product is approved by the U.S. Food and Drug Administration (FDA), it is the only one approved at this time. Additionally, there is no drug therapy for this type of valve condition.
Prior to the availability of TAVR, patients with high risk heart valve conditions , or determined to be inoperable, often went untreated. At the Heart Hospital Baylor Plano the heart team takes a comprehensive approach to evaluate these high-risk patients to determine the best treatment options. The team offers patients access to early stage TAVR clinical trials, the latest heart valve devices and a physician heart team with more than 10 years’ experience in transcatheter valve therapy.
“The Heart Hospital’s mission is to offer the latest, cutting-edge treatments to patients and achieve the highest quality outcomes. We’re thrilled to be among 25 sites to be awarded an investigational treatment that offers patients a variety of options to replace their heart valve via a catheter-based approach. This Transcatheter Aortic Valve Replacement not only helps to extend a patient’s life but, more importantly, it enhances their quality of life. We’re excited that Edwards Lifesciences Corp. continues to provide new innovations that allow surgical teams across the globe to expand offerings to high-risk, inoperable patients,” said David L. Brown, MD, Director of Interventional Cardiology and Transcatheter Valve Therapy.
Edwards Lifesciences Corp. received conditional approval from the FDA in August to initiate a clinical trial of the SAPIEN 3 device. The trial is evaluating the safety and effectiveness of the valve for the treatment of high-risk and inoperable patients with severe, symptomatic, aortic stenosis. The trial will enroll up to 500 patients to be treated with one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route using a small incision on the side, and the transaortic approach through a small incision in the chest and aorta.
If you are a patient, or are a family member of a patient suffering from severe aortic stenosis and are interested in learning more about transcatheter aortic valve replacement, please contact The Heart Valve Center of Texas at 1.855.4CV.CARE (1-855-428-2273).
By David J. Phillips (about Celgene)
Despite doubling in the value of its stock price in the last year, Celgene still offers investors a compelling growth story, assuming the drug maker can expand its pipeline of cancer treatments beyond multiple myeloma and successfully execute - pending regulatory approval - the launch of Apremilast in the crowded psoriatic arthritis market.
Much of the risk around Celgene continues to be its dependence on Revlimid to drive top-line growth (66% of net sales); nonetheless, analysts believe that the drug's composition-of-matter and method-of-use patents are solid, offering durable barriers to entry (from repeated generic challenges) out to 2023. Additionally, anticipated regulatory approval in a first-line setting for newly diagnosed multiple myeloma (MM) patients, combined with a benign neurotoxic side-effect profile, should bolster growth and lead to peak global sales of approximately $8 billion per annum by decade's end, up from an expected $4.15 billion this year.
Similar to Revlimid, the efficacious and benign side-effect profile of Pomalyst has favorably positioned Celgene's newest entry as a preferred third-line treatment with hematological oncologists in refractory/relapsed MM patients. Executing on its "keeping it in the family" strategy, management told analysts on the third-quarter earnings' call that a majority of refractory/relapsed MM patients failing on Revlimid are receiving Pomalyst instead of Amgen's newly acquired Kyprolis (carfilzomib).
Additionally, European approval in August, combined with eventual use in myelofibrosis (another disorder of the bone marrow), suggest Pomalyst could contribute another $1 - $2 billion to the company's MM franchise. Abraxane was initially approved in 2005 for metastatic breast cancer. Driven by expanded usage in non-small cell lung cancer and new patient starts in pancreatic cancer (September 2012 approval), this injectable form of the protein- bound chemotherapy drug paclitaxel, delivered a robust 60% increase in quarterly sales to $170 million. Abraxane could be the medicine that Celgene needs to broaden its oncology portfolio beyond blood cancers to solid tumors. Should the drug show clinical utility in additional indications, such as melanoma and Triple Negative Breast Cancer, peak annual sales could blow by current estimates of $1.5 billion - $2 billion.
Although growth prospects for Celgene's oncology franchise remain strong, the product portfolio remains highly concentrated. To justify a PE almost twice that of key competitors, the company needs additional revenue streams to offset these known risks.
One never knows for sure, but this looks like it is real. There is talk of FDA "breakthrough status" for Imetelstat. This could render the Incyte approach irrelevant. Do yourself a favor, and check it out.