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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Machaon who wrote (21458)	5/27/1998 8:05:00 PM
From: RXGOLF	Read Replies (1) \| Respond to of 32384

<<What do you think tomorrows action is going to be like? Will LGND jump up, on the news, and then settle back to around $14 (like always)?>> Good evening Robert, I just sent you a private message. The above is a question a lot of longs and shorts are asking after the news release this evening. I'm sure not smart enough to have the answer, but I feel more comfortable being long than I would being short at tomorrows open. With a company like this, we should see a few of these NDA's announced in the coming years. My personal bet is that Mr.Robinson and Co. have the expertise to take this thing and others to market. The FDA is a huge hurdle, but with the right compound and the right people taking the message to the FDA, drugs ARE taken to market. Good Luck longs, Greg

To: Machaon who wrote (21458)	5/27/1998 8:07:00 PM
From: bob zagorin	Respond to of 32384

BOP slid slightly further into the yellow on slightly less volume. the BOP pattern over the last two weeks has been to make a new high in the green; then slide back into the yellow but not as low as before; then make a higher high in the green etc. if this higher high, higher low BOP continues then tomorrow needs to be a big up today for BOP. ps. i think mr. mudcat ought to acknowledge that his oft-repeated assertion that the NDA was delayed was flat wrong.

To: Machaon who wrote (21458)	5/27/1998 8:29:00 PM
From: Flagrante Delictu	Read Replies (1) \| Respond to of 32384

Bob, at a minimum the filing of the NDA on time ought to rid the marketplace of the worry of whether LGND can or can't figure out appropriate time schedules; and, thereby allow the market to bet on the probability of the acceptance of the SRGN compound by the ODAC panel next Tuesday unhinderd by a potential negative reaction to another missed filing deadline. It's hard to believe LGND would have done the deal with SRGN before the ODAC meeting without a suspician of approval. A prior post seemed to indicate that Susan Atkins thought the chance of such was 90%. Let's hope she's right.

To: Machaon who wrote (21458)	5/29/1998 9:22:00 AM
From: Henry Niman	Respond to of 32384

bob, Speaking of breast cancer and Panretin, the ASCO abstracts are now available to the public, including the study combining Panretin (9-cis retinoic acid - 9cRA, LGD1057) with Tamoxifen to treat advanced (Stage IV) breast cancer patients. The study was very small (8 patients) but 25% (2 patients) have responded to the treatment and remain on the protocol at 11 and 14 months. This study was conducted by the National Cancer Institute: A PHASE I TRIAL AND PHARMACOKINETIC (PK) STUDY OF 9 CIS-RETINOIC ACID (9cRA, LGD 1057) AND TAMOXIFEN (Tam) IN METASTATIC BREAST CANCER PATIENTS. J.A. Lawrence, R.F. Murphy, R. Caruso, M. Shovlin, M. Noone, M. Kaiser, K.H. Cowan, P.C. Adamson, J. Zujewski, Division of Clinical Sciences, National Cancer Institute, Bethesda, MD. The antiproliferative, differentiation, and apoptotic effects of retinoids have led to their development for breast cancer. The inhibitory effect of Tam is potentiated by the addition of retinoids in preclinical models. A phase I trial and PK study of 9cRA and Tam in metastatic breast cancer patients was performed. 9cRA was administered p.o. daily at 5 planned dose levels of 50 to 140 mg/m2/d. Following 4 wks of 9cRA administration, patients received Tam 20 mg q.d. Dose limiting toxicity (DLT) was defined as >/= to grade 3 non-hematologic toxicity, grade 4 neutropenia >3 days, or grade 4 thrombocytopenia. Maximum tolerated dose (MTD) was defined as the highest dose level that not more than 1/6 patients experienced a DLT. Eight stage IV breast cancer patients (6 ER/PR positive, age 49 to 64 y.o.) were entered. Prior therapy included hormonal (n = 5) and chemotherapy (n = 6). At 90 mg/m2/d, 3/5 patients experienced DLT prior to Tam administration: grade 3 headache (n = 1), grade 3 hypercalcemia (n = 1), and grade 3 pulmonary toxicity (n = 1). Hyperlipidemia was seen (n = 7) but not considered a DLT. One of 5 patients had an asymptomatic delay in the rod-cone break by Goldman Weekers dark adaptometry at 8 weeks. Two patients (dose 70 and 90 mg/m2) demonstrated improvement in their pulmonary metastasis and remain on therapy at 11 and 14 months. The peak plasma concentration of 9cRA following a 70 mg/m2 dose was 1.6 ñ 0.9 M. Plasma AUC decreased from 237 ñ 135 M on day 1 to 135 ñ 125 M by day 28. In the pt with a rod-cone break delay, retinol decreased to 25% of baseline levels. Additional patients are being evaluated at the 70 mg/m2/d dose level. A well tolerated combination of such agents may be useful in the management of metastatic breast cancer and in the development of chemoprevention strategies.