When Stemline Therapeutics (STML - Get Report) makes a pitch to investors, the company's presentation includes a slide containing Internet message board posts from two patients with a rare form of blood cancer. Both patients say they had complete responses following treatment with Stemline's experimental drug SL-401.
But Stemline edited the message board posts, omitting information which would help determine if SL-401 or some other therapy was responsible for the complete responses observed in these cancer patients.
Stemline also issued a press release claiming one of the cancer patients experienced no "serious side effects" following treatment with SL-401. But this patient's own blog described treatment with SL-401 as "difficult and unpredictable" with "harsh side effects" that required a prolonged hospital stay.
Stemline's investor slide deck and its press release accurately describe the experience cancer patients have following treatment with SL-401, said CEO Ivan Bergstein in an interview last week.The Leukemia and Lymphoma Society, which runs the message board from which Stemline took the cancer patients' posts, was okay with their use, said Bergstein. "We worked together with them on our investor slide deck," he said. That's not exactly how the Leukemia and Lymphoma Society views the situation. Chief Mission Officer Lou DeGennaro says the society has met with Stemline to discuss SL-401 but was not aware patient posts from its message board were being used by the company to promote its stock. "We don't have decision-making authority over the the message board excerpts but we have asked Stemline to reconsider their use," said DeGennaro. At Monday's $21.91 close, Stemline shares have more than doubled in value since the company went public in January at $10 per share, although the stock is off more than 50% from its Oct. 1 high of $47 per share. The company's lead pipeline drug is SL-401, a biologic therapy consisting of a protein, IL-3, linked to a toxic diptheria payload. SL-401 is designed to attach itself to IL-3 receptors found on cancer stem cells associated with blood-related cancers. Once attached, the diptheria payload is released inside the tumor, killing it. Next year, Stemline is planning a "pivotal" phase II study of SL-401 in patients with refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), a ultra-rare form of cancer that attacks a specialized form of immune cells found in the bloodstream and bone marrow. Stemline has not yet conducted its own clinical trial of SL-401, so the small amount of data presented by the company to date comes from outside investigators who have used the drug to treat their own BPDCN patients. Updated data will be presented later this week at the American Society of Hematology (ASH) annual meeting. But without FDA permission (yet) to run its own clinical trial, Stemline is reliant on anecdotal patient information to promote SL-401 -- and its stock -- to investors. Notably, Stemline's investor presentation includes this slide:
Thirty days after SL-401 treatment, the patient achieved a CR, with no evidence of malignant BPDCN cells in his bone marrow or bloodstream and his blood cell counts; in particular, his absolute neutrophil and platelet counts returned to normal levels. Furthermore, he did not experience any serious side effects from SL-401 treatment.This patient and his wife write a blog on CaringBridge.org discussing his fight against BPDCN. This is how they describe treatment with SL-401:
We are back at MD Anderson for follow-up after finally completing the clinical trial in Temple. As I write, [name redacted for privacy] is preparing for a platelet blood transfusion. One of the side effects of his treatment is low platelets but we were hoping that he could avoid any more pricks and transfusions once he was discharged. Guess not. The last few weeks have been difficult and unpredictable. What we thought (and were led to believe) was a fairly mild treatment, has turned out to be a very potent drug with some harsh side effects. What was supposed to be 5 days in the hospital turned into 8 and consisted of fevers, chills, headaches, GI issues, sleepless nights, etc.This patient's cancer returned in early 2013, requiring more hospital stays and further treatments. Last month, a second cycle of SL-401 was not successful, according to his blog.
As I write, we are on a flight home. [Name redacted for privacy] was able to get the full 5 doses of treatment [SL-401] but his body did not respond like we had hoped. His white blood cells unfortunately dropped to zero and all his other counts stayed low as well. The easiest explanation is that [name redacted for privacy] maintained some antibodies from last treatment that negated the drug (even though we tested for this and his anti-body level was low) or that possibly the disease burden was too high.Stemline hasn't issued a follow-up press release disclosing the inability of "CR pt #1" to respond to a second cycle of SL-401. "We have not publicly reported on that," said Stemline CEO Bergstein. "This is not what we're talking about now. We only report on confirmed information based on patient [medical] charts, not what's found on blogs." But what about Stemline cribbing posts from cancer patient message boards? "I'm not going to let you play 'gotcha' with me," said Bergstein.
-- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.